Safe Place: Clinical Utility and Feasibility of a Multi-Disciplinary Intervention for Children with Sensory Processing Disorder and Complex Trauma – a Feasibility Study

Abstract

Issues of feasibility, acceptability, satisfaction, safety, and fidelity were examined in a single case program review as an initial step to assessment of the clinical utility of the SAFE PLACE program, a unique multi-disciplinary intervention program for children with complex trauma and sensory processing disorder. The feasibility of conducting a pilot intervention study was also examined. A mixed methods, single-case, program review was conducted. The intervention was the 12-week SAFE PLACE program with pre and post-intervention baseline periods. Random intervention sessions were assessed for fidelity. Post-program interviews and questionnaires were utilized to obtain qualitative and quantitative information on feasibility, acceptability, satisfaction, and safety. The SAFE PLACE fidelity measure demonstrated the intervention was safe and implemented with fidelity to the intervention model. The intervention was acceptable to the family with an average rating of 4.3 (between acceptable and perfectly acceptable) on a five-point scale. The family was very satisfied with the intervention and its outcomes with a rating of 4.75 (between satisfied and very satisfied). Numerous positive qualitative comments about participation in the program and outcomes of the intervention were spontaneously provided by the family. Staff satisfaction rating was 4.3. Scheduling, staffing and financial reimbursement feasibility challenges were identified. Preliminary outcomes of the intervention suggested positive results and provided guidance for selection of future clinical and research outcome measures. The SAFE PLACE intervention was found to be a safe, acceptable intervention with high caregiver satisfaction that could be delivered with fidelity. The program was deemed feasible for future research studies but scheduling, staffing and financial reimbursement challenges may inhibit implementation in routine clinical practice.

In recent years, there has been an increased interest in the underpinnings of and interventions for children’s affect and behavioral dysregulation challenges that impact daily life function, skill performance and participation across settings. These dysregulation challenges are often associated with mental health concerns which may include histories of complex trauma, abuse and attachment disorders. The Substance Abuse and Mental Health Services Administration (SAMHSA) has stated that childhood exposure to traumatic events has become a major public health problem in the United States (SAMHSA 2011). Understanding what constitutes a traumatic event has also increased. Traditional views of trauma, as defined events such as physical and sexual abuse, now include awareness of the increased risk of complex trauma on children who have spent time in orphanages or foster care, were born prematurely, suffered medical trauma, lived in poverty, or survived a natural disaster or community violence (Spinazzola et al. 2013). The influence of exposure to these types of traumatic events on children’s ability to develop attachment bonds with caregivers (Miranda et al. 2019), participate in daily life activities at home, school and community, and to regulate emotions and behavior (McCall et al. 2019) has become a subject of much interest.

In the mental health literature there is an increased understanding of the complex inter-relationship of children’s sensory, physical and emotional experiences and their neurobiological, social-emotional functioning and development (Champagne and Stromberg 2004; Koomar 2009; Streeck-Fischer and van der Kolk 2000; van der Kolk et al. 2005; Warner et al. 2013). Authors such as van der Kolk (1994), Perry (2006), and Ogden et al. (2006) have raised awareness of the relationship between traumatic events and body-based disorders. Simultaneously, occupational therapists have begun to play a greater role in pediatric mental health (AOTA 2016), especially in the area of sensory-based trauma intervention and attachment promotion (AOTA 2015).

Occupational therapists providing Ayres Sensory Integration® (ASI) intervention (Smith Roley et al. 2007) routinely address problems in sensory regulation and motor performance in children with Sensory Processing Disorder (SPD). SPD is a problem with processing and integrating sensory inputs which results in deficits in making appropriate responses to sensorimotor demands and impacts between 5 and 16% of otherwise typically functioning children (Ahn et al. 2004; Ben-Sasson et al. 2009a) and up to 95% of children with autism spectrum disorder (Ben-Sasson et al. 2009b). These problems impact children’s ability to learn, be self-sufficient, and engage in meaningful lives (Chien et al. 2016; Dunn et al. 2016). Occupational therapists with expertise in provision of ASI intervention are increasingly asked to treat children with SPD who also have complex trauma and attachment disorders (Scanlan and Novak 2015). Similarly, psychotherapists who treat children with trauma histories are identifying increasing numbers of children who also present with sensory sensitivities characteristic of SPD that appear secondary to the trauma (Engel-Yeger et al. 2016). Because of their physiological sensitivities, children with SPD are often more vulnerable to adverse affects from traumatic experiences.

A variety of current or emerging treatment models and programs combining sensory and psychotherapy approaches to address the trauma experiences of children and their families exist. These include sensory-based programs such as the SMART: Sensory Motor Arousal Regulation Treatment program (Warner et al. 2012), and Sensorimotor Psychotherapy (Ogden and Minton 2000) as well as psychotherapy models such as the Neurosequential Model (Barfield et al. 2012), and Dyadic Developmental Psychotherapy (Becker-Weidman and Hughes 2008). While clinically popular, many of these programs are not yet supported as evidenced-based interventions. In addition, most programs are conducted exclusively by mental health professionals, even though the intervention may have a sensory basis. Occupational therapy services are typically provided separate from mental health services.

The increase in complexity of client needs has led to a call for new multi-disciplinary models of care. Not only has there been an increased need for occupational therapists to be involved in provision of client care of those who have experienced trauma, but there is a need for increased collaboration among professionals and parents involved with the child. With the increased awareness of the importance of addressing sensory and body-based factors associated with trauma healing and proliferation of sensory-based interventions, there is an identified benefit for attachment and trauma processing to occur within a sensory-based environment which promotes regulation and adaptive responses. The SAFE PLACE model and intervention program was designed to meet these needs. As a multi-disciplinary model, SAFE PLACE differs from other mental health psychotherapies and sensory-based programs in the sensory-rich environment used for the SAFE PLACE intervention, the full inclusion of parents in the treatment session, and the simultaneous and collaborative treatment provided by occupational therapy and mental health practitioners to both the child and their caregiver.

Developed by occupational therapist, Jane Koomar, PhD, OTR/L, FAOTA and psychologist, Daniel Hughes, PhD, SAFE PLACE is both a theoretical model explicating the relationship between sensory processing, disrupted attachment and complex developmental trauma concerns in children; and a specific 12-week collaborative, multi-disciplinary, sensory integration-based trauma-informed intervention program among occupational therapists, psychotherapists, and parents for children with SPD and complex trauma-attachment concerns. SAFE PLACE provides a therapeutic framework for service providers and parents which emphasizes development of body-based regulatory and adaptive functions with co-regulation and intersubjective experiences, deepening of attachment bonds and security, and processing and healing of traumatic experiences in the context of a sensory integration intervention process.

The development of the SAFE PLACE program has reached the point where it has become necessary to examine whether this intense program can be practically implemented in clinical practice and what the implications of those findings might be for future intervention research studies.

Implementation of a complex multi-disciplinary intervention can be challenging. Feasibility studies are one way to evaluate aspects of intervention implementation whether in clinical trials or in practice. Most authors discuss feasibility in regard to implementation of randomized clinical trial intervention research. Zwarenstein et al. (2008), however, articulated that small scale pragmatic trials which examined feasibility, safety, acceptability and fidelity of an intervention could inform decisions about practice and help clinicians choose between options for care (Schwartz and Lellouch 1967). Schaaf et al. (2014) used this model to examine the feasibility, safety, acceptability and fidelity of Ayres Sensory Integration® intervention. Orsmond and Cohn (2015), however, stated that feasibility studies should focus on the process of developing and implementing an intervention. This information could then be applied to higher level research or clinical practice. They identified the main objectives of a feasibility study as evaluation of: a) recruitment capability and resulting sample characteristics, (b) refinement of data collection procedures and outcome measures, (c) acceptability and suitability of the intervention and study procedures, (d) resources and ability to manage and implement the study and intervention, and (e) preliminary outcomes and participant responses to the intervention.

As an initial step to determining the clinical utility of the SAFE PLACE program and the feasibility of completing a larger pilot intervention study, issues of feasibility, acceptability, satisfaction, safety, and fidelity were examined. In addition, process issues related to clinical and research applications recommended by Orsmond and Cohn were also investigated. Application of findings to further clinical practice and research will be discussed.

Methods

Design

This study was part of a program review conducted at a private sensory integration-based occupational therapy clinic which utilized a single case mixed-methods design incorporating a baseline-no treatment, intervention and follow-up phases.

Participants

A single case was selected for investigation for this study due to the preliminary and resource intense nature of the SAFE PLACE program. Therefore, one child and family participated in the program review and were recruited as a sample of convenience. The child, Ethan (name changed for privacy), was a 4.10 year old male adopted from Russia who had received no previous occupational therapy or mental health services. Ethan met the criteria for both a sensory processing and trauma-attachment disorder. Ethan’s mother, the primary caregiver, attended the majority of the intervention sessions. Both parents were professionals with their own businesses. Inclusion criteria for child and parents are listed in Table 1. There was no cost to the family for participation in this study.

Table 1.

Child and parent participant inclusion criteria

•aged 4–15 years •with sensory processing dysfunction and •with complex trauma and attachment as identified by the OTA SAFE PLACE Intake Coordinator; Traumatic Events Screening Inventory – Parent Report Revised •no parent/guardian report of Autism Spectrum Disorder, uncontrolled seizure disorder, neurological motor coordination problem (e.g. cerebral palsy), or mental health diagnoses involving psychosis (e.g. manic-depression or schizophrenia) •child and parent/guardian speak sufficient English to fully participate in the study •family committed to fully participating in the program

Program staff consisted of an “assessment” occupational therapist, an “intervention” occupational therapist and a mental health practitioner. The “assessment” occupational therapist completed intake, pre- and post-intervention evaluations of sensory and motor performance as well as the intake, pre and post-intervention parent goal-setting interviews and intervention goal-setting. This therapist was not involved in the intervention. The “intervention” occupational therapist and the mental health professional (a psychiatrist) conducted the weekly intervention sessions and parent consultation sessions. All program staff had over 20 years’ experience, were licensed and credentialed in their appropriate field, and met the educational criteria outlined by the SAFE PLACE Fidelity Measure with regard to clinical experience, sensory integration training and mental health training in complex trauma and attachment. See Table 2 for details regarding staff qualifications.

Table 2.

Qualifications of SAFE PLACE professionals

Area of Knowledge	Discipline
	Occupational Therapist	Mental Health Professional
Sensory Integration	•Must have expertise in SI theory and intervention •Be SIPT certified •Have 5-years experience in sensory integration •50 hours of mentoring in sensory integration	•Must have good understanding of SI theory and intervention or taken a two day SI theory and two day intervention course •Recognize impact of sensory inputs on arousal •Understand what inputs are provided by specific pieces of equipment
Attachment	•Understanding of and ability to use PACE •Good understanding of attachment theory •Have taken Dan Hughes’ one day course on attachment and trauma	•Expertise in area of attachment theory and intervention •Have taken Dan Hughes’ Level 1 course on attachment and trauma
Trauma	•Good understanding of trauma theory •Ability to recognize signs and symptoms of trauma reactions •Have available ongoing consultation/mentoring from a mental health professional •Have taken at least one course (6 hours) on trauma informed care	•Expertise in trauma theory and intervention •Have 5 years experience in counseling/psychotherapy in the area of trauma and attachment •Have at least 12 hours coursework or continuing education in trauma and 12 hours in attachment •Have 50 hours of mentoring in trauma and attachment counseling/psychotherapy

Procedures

Ethan’s mother completed a comprehensive one-hour screening for appropriateness for the SAFE PLACE program, the child’s complex trauma and sensory integration problems were confirmed, and the child was referred for participation in the SAFE PLACE program. At enrollment the family was informed about the program review study and informed consent was obtained for participation. The study was designed with a 12-week pre-intervention baseline, 12-week intervention, and 12-week post-intervention follow up period. The child completed an occupational therapy evaluation and his mother completed study measures at the start and end of the pre-intervention baseline, at the end of the intervention phase and at the end of the follow-up period, See Table 3 for outcome measures collected at each stage.

Table 3.

Timeline of completion of study outcome measures

Measure	Family member	Staff	Pre-baseline	Post-baseline/ Pre-intervention	Post-intervention	Follow up
Gross motor and sensory processing measures
Beery VMI	Child	AT		X	X	X
ClinOb	Child	AT	X	X	X	X
MABC	Child	AT	X	X	X	X
SPM	Mother		X	X	X	X
Behavior and cognitive measures
BASC	Mother		X	X	X	X
BRIEF	Mother		X	X	X	X
Social skills measure
SSiS	Mother		X	X	X	X
Functional performance measures
GAS goals	Mother	AT	X	X	X
PEDI-CAT	Mother		X	X	X	X
PPDA	Mother		X	X	X
REAL	Mother		X	X	X	X

Note. Beery VMI - Beery-Buktenica Developmental Test of Visual-Motor Integration, Sixth Edition; ClinOb – Sensory Integration Clinical Observations; MABC - Movement Assessment Battery for Children – 2; SPM - Sensory Processing Measure Home; BASC - Behavior Assessment System for Children – Third Edition Parent Rating Scales; BRIEF - Behavior Rating Inventory of Executive Functioning Parent Form; SSiS - Social Skills Improvement System Rating Scales Parent Form; GAS - Goal Attainment Scaling; PEDI-CAT - Pediatric Evaluation of Disability Inventory - Computer Adaptive Test; PPDA - Parenting Profile for Developing Attachment; REAL - The Roll Evaluation of Activities of Life Rating Form; AT - Assessment Therapist

Intervention

The intervention was provided according to the manualized protocol outlined in the SAFE PLACE Intervention Manual (May-Benson and Sawyer 2015) by the “intervention” occupational therapist and the mental health professional with the child and the parent actively involved in all treatment sessions. Professionals were trained in implementation of the SAFE PLACE intervention by the primary investigator via a four-hour training session. Intervention consisted of: a) 60-min treatment sessions 2 times per week for 24 sessions with child, parent, occupational therapist and mental health professional which were video recorded; b) 60-min parent consultation sessions once per week for 12 sessions with the parent, occupational therapist and mental health professional; c) 60-min professional collaboration and intervention planning sessions once per week for 12 sessions with the occupational therapist, mental health professional and primary investigator.

At the end of the intervention phase the mother completed a progress interview with the assessment therapist to score Goal Attainment Scaling (GAS) intervention goals which had been set and checked for technical quality and relevance to the family before the start of the intervention. For program evaluation purposes, the mother, occupational therapist and mental health professional met with the primary investigator separately at the end of the study to discuss their participation experiences. The parent and all study staff completed the SAFE PLACE Feasibility, Satisfaction and Acceptability questionnaires. During the post-intervention follow-up period, the family elected to have the child receive individual direct occupational therapy and psychotherapy which was anticipated.

Outcomes

Outcome data collection involved direct assessment of the child, caregiver completed questionnaires and parent interview meetings. Additional data was collected from professionals providing screening, assessment and intervention as well as administrative staff involved in scheduling study sessions. Direct assessment measures examined gross motor skills. Caregiver questionnaires examined areas of sensory processing, behavioral regulation, social skills, and functional skills performance and participation. Goal attainment scaling was completed through parent interview and measured functional performance. See Table 3 for a complete list of outcome measures.

Fidelity

Integrity of the intervention was confirmed using the SAFE PLACE Fidelity Measure (May-Benson 2016). This four-part measure was developed to assess adherence to the SAFE PLACE program. Sections I and II outline therapist qualifications for the occupational therapist and mental health professional. Areas of minimum training are specified for sensory processing, attachment and trauma expertise. Section III details structural elements necessary to implement the SAFE PLACE intervention and includes components of physical safety of space, availability of suspended equipment and sensory and praxis materials. Section IV articulates the process elements identified as integral to the delivery of the SAFE PLACE intervention. This includes pre-intervention elements related to screening and assessment for appropriateness of the intervention, seven contextual factors and seven interpersonal factors. These factors are articulated in the SAFE PLACE Intervention Manual and were supported via a validity study which demonstrated inter-rater alphas and ICC’s > .87 (May-Benson and Teasdale 2019).

Results

Descriptive statistics and qualitative comments in written and interview format were used to summarize parent and therapist feedback regarding feasibility, acceptability, and satisfaction. Clinic accident report forms and study adverse event records were used to examine safety.

Recruitment and Retention Capability

It was easy to recruit one participant and family for this study. Numerous children were identified by clinical staff as potentially appropriate for the program. Two individual children were identified as particularly interested in participation within a 2–3 week time period and one was recruited. The selected participant easily met the inclusion criteria. Parent commitment to the project was high and all parts of the study were completed with the exception of the final post-intervention baseline parent goal evaluation interview which was not able to be scheduled after repeated attempts due to the parent’s busy work schedule.

Evaluation of Data Collection Procedures and Outcome Measures

Direct assessment of the child was timely, within a week of the anticipated timeline. Pre-intervention direct assessment demonstrated some missing data on sensory integration clinical observations (May-Benson 2015) due to the child being unable or unwilling to complete the activities and assessment time running out. After intervention and at final re-assessment, however, the child was able to complete nearly all items in a timely manner. The parent in this study was motivated to complete the parent measures, but due to the number of measures involved in this preliminary study, return of measures often took somewhat longer than anticipated. In addition, vigilance was needed to assure completion of all parts of questionnaires as several measures at each time period had to be returned for completion due to some items being missed.

A wide variety of measures were initially selected for this study in an attempt to capture change in all possible areas of function as an initial guideline for use of possible future measures with the program. At initial data collection it was noted that the child was rated as performing well within average limits on some parent measures and thus had ceiling effects due to the measures use of t-scores. This left little if any room for change on subsequent ratings of the measures.

Satisfaction, Acceptability and Program Participation

Feasibility of implementing the SAFE PLACE program was evaluated, in part, by the satisfaction with, acceptability of and participation in the program. These factors were reported by the parent participant and the SAFE PLACE program staff.

Satisfaction

Parent and staff involved in the study rated their experience with the intervention as being “very satisfied” on 48% of items and as “satisfied” on 44%. The mother expressed that the intervention process, while intensive with three hours per week of intervention between child and parent sessions, was a “fantastic experience [which] had a significant impact on my son and our relationship”. She further reported, “The consultation sessions not only helped my son, but helped me to be more aware of my reactions and learning new methods and techniques for dealing with his behaviors in a positive, loving and effective manner.”

Acceptability

Acceptability of the amount of paperwork, space, number and frequency of sessions was rated overall as “acceptable’ by the parent with 70% of items rated “acceptable” and 20% rated as “perfectly acceptable”. Acceptability of overall participation, changes observed in child and changes in parental interactions with child were rated 100% “perfectly acceptable”. The parent reported that “The ability to participate in this intervention program was a blessing! It had a major impact on my son; his confidence in his ability to perform certain physical tasks, his interactions with me changed dramatically.”

Program Participation

The SAFE PLACE staff reported that overall participation in the program, and scheduling and sustaining the necessary appointments was “easy” or “neutral”. Rescheduling of treatment and consultation sessions was reported as “difficult”. The parent reported that the intake process and completion of child assessments and required questionnaires was “neutral”. Scheduling and rescheduling of sessions and consultations was reported as “difficult”, as was participation in the sessions and the overall program. Attending the various sessions was reported as “very difficult”. In the comments, the parent clarified that the difficulty in all of the above was in regard to scheduling because of her busy, very full work schedule, the travel time to and from the center, and time of day of appointments. She noted that afterschool and weekend hours would have made participation much easier. In spite of scheduling challenges, retention of the participant in this study was not a problem. The family was very committed to the intervention and expressed a desire for continued services in both the occupational therapy and mental health arenas at the conclusion of the study.

Resources and Management of Study and Program Implementation

As expected, this program was very resource intense in terms of space, time, staffing and finances.

Space, Equipment, and Safety

Appropriate intervention space and equipment was available at the clinical site for the intervention which met the criteria outlined in the SAFE PLACE Fidelity Measure. No adverse events regarding physical safety were reported over the 24 intervention sessions. The mental health professional was trained on physical safety procedures in use of the equipment and an occupational therapist was present at all times to monitor safety of child and parent while in the sensory integration treatment spaces. There were no adverse events regarding emotional safety. Parent rated 100% of items asking about physical and emotional safety as being “very comfortable”. She further reported she felt safe to express herself in intervention and consultations.

Therapeutic Staff

Recruitment of therapeutic staff was initially challenging. Occupational therapists for assessment and intervention were recruited easily. For the “intervention” therapist, however, this required some initial movement on her regular full-time treatment schedule to create time for this program. This was possible but required lead time to accomplish prior to the initiation of the program. The mental health practitioner was particularly challenging to recruit as there was not a regular mental health practitioner on staff in the clinic. Several practitioners were approached and expressed interest in participating, but the time commitment was difficult for them to accommodate in their already full schedules. A psychiatrist was eventually located who was willing and able to accommodate the scheduling, however, the cost of hiring this consultant was higher than originally budgeted.

Scheduling

Coordination of multiple individual’s schedules increased the complexity of implementation of the study. Scheduling of sessions for the intervention required some initial changes in clinician availability that needed to coincide with clinic space and parent availability. This involved the less used early morning clinic session times. The parent and client were available at the designated early morning times, however, both parents were professionals with jobs that periodically required last minute appointments, over which they had no control, that were scheduled during treatment sessions. As a result, Ethan’s mother attended 19 of the 24 sessions, his father attended four and a significant caregiver attended one. This had a benefit of allowing all adults involved with the child to have an increased understanding of the child’s needs. Approximately 46% of the 24 treatment sessions over a 3 month period needed to be rescheduled due to child/parent/clinician illness, holidays, staff vacations, parent work conflicts and inclement weather. With the rescheduled sessions, the intervention was completed in 15 weeks. Another scheduling challenge was that the family was frequently late to treatment sessions for a variety of reasons, sometimes by as much as 30 min. The clinicians attempted to accommodate the family as much as possible, often running over into their planning time.

Finances

The financial aspects of the SAFE PLACE program were considered. The cost of two therapeutic staff for four hours each per week per child for a 12 session period was examined. Most parents desire insurance reimbursable services, however, as this service involves co-treatment of two therapists, only one service is reimbursable per session. In this case the occupational therapy services were reimbursable by insurance. The parent consultation session may ultimately be reimbursable as a mental health service for the parent if approval for the center to provide insurance-based mental health services is obtained. The clinician planning session was not reimbursable at all as it was not a direct service. For this project services were provided to the family free of charge as part of the program review study.

Study/Program Personnel, Expertise and Management

Study personnel were appropriate for this project and adequate time was allotted for study management. All clinicians had required expertise in their respective areas. The primary investigator and research staff had sufficient expertise to implement the study effectively. For one participant, the primary investigator and research assistant were sufficient staff for study management. Additional support staff would be needed, primarily for scheduling and video recording, for studies with larger numbers of participants. Additional clinical staff or additional hours for current staff would also be needed.

Fidelity Ratings

Adherence to the SAFE PLACE intervention was examined via use of a fidelity measure. Parts I – III of the fidelity measure were rated at the start of the study and met all criteria at 100%. The process elements articulated in Part IV were assessed during the intervention. Six fidelity checks were completed across the study. Intervention was divided by four-session blocks (approximately every two weeks) and a single one hour session was randomly selected from each block. The fidelity checks were completed by the primary investigator who viewed the intervention session and rated each session on the fidelity measure. The 14 items on the fidelity measure were rated on a scale of 1–4 from likely did not occur to likely did occur. All sessions met fidelity to the intervention at 85% or better. Thus adherence to the proposed intervention was supported.

Preliminary Participant Response to Intervention

Preliminary participant response to intervention was examined via standardized parent-report, direct evaluation assessments, goal attainment scaling and qualitative participant feedback. Change in performance was examined using a 90 or 95% confidence interval for each measure depending on standards identified in the test manuals. In general, outcomes reflected a decrease in skills over the pre-intervention baseline period, a return to baseline or increase in skill over the intervention and variable responses over the post-intervention follow-up period.

Gross Motor and Sensory Processing Outcomes

Gross motor and sensory processing outcomes included the Movement Assessment Battery for Children-2 (MABC: Henderson et al. 2007), Beery-Buktenica Developmental Test of Visual-Motor Integration, Sixth Edition (Beery: Beery and Beery 2010), and Sensory Integration Clinical Observations (May-Benson 2015) as direct assessments and the Sensory Processing Measure (SPM: Parham et al. 2007) as a parent report measure. These measures captured deficit areas at pre-test and were sensitive to change across the baseline and intervention periods. Intervention outcomes in this area reflected significant improvement over the intervention period. The motor tests demonstrated continued improvement over follow up, however, sensory processing results were variable from decreased scores to maintenance of performance.

Behavioral and Cognitive Outcomes

Behavioral and cognitive outcomes were measured with the Behavior Assessment System for Children, Third Edition (BASC: Reynolds and Kamphaus 2015) and the Behavior Rating Inventory of Executive Function (BRIEF: Gioia et al. 2000). Both of the measures reflected deficit areas at pretest and were sensitive to changes over the baseline and intervention period. The BASC had a number of missing values at pre and post-baseline because the mother felt she was not able to rate the child’s performance on many items. By post-intervention, however, all items were able to be scored for both tests with the child being able to complete an additional six sections from pre- to post-testing. Items on both tests that reflected typical performance remained consistent across measurement periods. Response to intervention over deficit areas was difficult to determine with these measures. Many scores demonstrated a decrease from pre to post-intervention with either a sustained or decrease in performance at follow up. However, a number of those scores demonstrated an improvement in performance over the pre-intervention baseline, so it was difficult to determine if the positive change over intervention was change in parent ratings, a trend toward improvement which began before intervention, or the intervention itself.

Social Skills Outcomes

Social skills outcomes were measured using the Social Skills Improvement System (SSIS: Gresham and Elliot 2008). For this child, this outcome was not a useful measure. The parent reported the child’s performance to be within average limits on all sections, at all times, although significant behavioral challenges existed. As a result, repeated measure of this outcome did not reflect any change as there was little room for improvement in scoring.

Functional Performance Outcomes

Functional performance outcomes were measured using the Roll Evaluation of Activities of Life (REAL: Roll and Roll 2013), Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT: Haley et al. 1992), goal attainment scaling (GAS) and the Parenting Profile for Developing Attachment (which measured parent outcomes). As with the SSIS, at baseline, the parent rated the child within average limits on both the REAL and the PEDI-CAT, although functional challenges in these areas were evident during the intervention sessions and parent interviews. As a result, there was little room for change and parent ratings remained stable across the repeated measure of these outcomes.

GAS goals were established at the start of baseline and re-assessed at post intervention. Individualized goals reflected challenges in self-regulation, activities of daily living, social participation, and fine motor skills. The GAS goals were sensitive to meaningful changes for the family and, at post-testing, the GAS t-score was 53 which reflected a greater than expected change for the intervention period. Qualitative responses by the parent during consultations and the GAS interview reflected anecdotal evidence of a reduction in negative child behaviors including violence towards the parent and increased parent understanding of those behaviors when they did still occur. Increased parent understanding was also reflected in the improvement in perception of the self on the Parenting Profile for Developing Attachment and in the final parent interview.

Discussion

This program review focused primarily on issues related to clinical implementation of the program. Results demonstrated that the SAFE PLACE program may be implemented with safety and fidelity. Parental and staff acceptance and satisfaction with the program was high and very positive. Challenges identified to conducting larger studies and clinical implementation included cost of staff and scheduling. Outcome measures were examined and sensitive measures were identified. Preliminary effectiveness, while clearly limited in generalizability, was suggested in areas of motor performance, sensory processing and behavioral regulation for this participant. Additional examination of these areas as sensitive outcomes is recommended.

Several procedural changes and additions were expressed by both the family and the therapeutic staff. Although parents were informed about the nature and expectations of the SAFE PLACE program both the parent and therapists expressed a desire for more parent education on sensory integration and SAFE PLACE prior to the first treatment session. As a result of this feedback, an additional parent session to occur before initiation of the child’s treatment was added to the proposed intervention schedule for future implementation of the program. In addition, parent materials on sensory integration and SAFE PLACE have been developed to facilitate this education. This program review also highlighted the need to designate time (approximately 5–10 min) at the end of each intervention session for note writing for the therapists. An additional concern that arose was the strong desire of the mental health practitioner to provide ancillary advice to the parents on nutrition and diet, areas of expertise for her. Although these topics might be addressed in routine therapy, it was decided that addition of these interventions might confound this project. It was difficult for both clinicians to restrict their therapeutic tools to only those advocated by the SAFE PLACE program. In clinical practice it is possible that additional therapeutic tools will be integrated into the SAFE PLACE intervention sessions although the impact of those changes on intervention outcomes is unknown.

Recruitment of a single participant for this study was easy. In a larger intervention study, however, the need for a no-treatment baseline before and after the intervention are likely to present a barrier to participation. In this study it was more challenging to collect data and schedule follow up visits after the intervention had been completed even with a committed parent. In clinical practice there would be no baseline periods and commitment to a 12-week program is more feasible. The presence of appropriate clients is not a barrier as a number of clients met criteria for participation in the program, but the intensive nature of program makes it most viable for individuals in crisis or who have a strong commitment to change at that time. It was clear that this type of program was needed and desired by families.

Scheduling presented one of the largest challenges in this study. The center used for this study was a large private occupational therapy clinic specializing in sensory integration with over 11 large treatment rooms available. During the prime treatment hours of 9:00 am to 5:00 pm there were routinely 11–13 clinicians treating in the clinic space. As the SAFE PLACE sessions were videotaped and there were routinely 4 adults (therapists, parent and videographer) and the child present during a treatment session, intervention sessions most desirably occurred (for confidentiality, space management and therapeutic reasons) when there were no other children and therapists present. This requirement challenged scheduling and the lack of availability of after work and weekend hours was reported as a limitation by the parent. In addition, the need to reschedule nearly half of the intervention sessions was excessive, resulted in a three week extension of the program, and the flexibility demonstrated in this study is generally not sustainable in a clinic setting. The use of make-up therapists, while less therapeutically optimum, may be necessary to maintain a regular therapeutic schedule. These experiences highlighted the need to have staff time that was dedicated to the SAFE PLACE program. Time commitments for this program are challenging for most clinicians to accommodate when they have a full clinical schedule. Hiring new staff on a salaried full or part-time basis with designated hours for this program was determined to be the best way to manage this limitation. This experience resulted in the expectation that future research or clinical program implementation may need to allow a longer time frame than 12 weeks for the family to receive the requisite 24 treatment sessions. It was noted that it is not unusual to have tardiness and missed treatment session in routine clinical intervention, but the need to accommodate scheduling in a relatively short amount of time was more extreme than typically seen in clinical practice.

Finances were also identified as a possible barrier to clinical implementation of the program. While grant funding would be expected for future research studies, clinical reimbursement would need to come from insurance or private pay sources. As noted, the occupational therapy services for the child may be insurance reimbursable but the mental health services likely will not be in many clinical settings. The parent consultation session may ultimately be reimbursable as a mental health service for the parent if the center is an approved provider for insurance-based mental health services. Regardless, unless insurance models of service are changed, only one therapeutic service may be reimbursed per treatment. It is possible that parents may pay privately for the unreimbursed services. It is common to pay out of pocket for both occupational therapy and mental health services. The intensive nature of this program, however, condenses the expense into a short time period. It is likely that many parents will be willing to cover these costs, but this may result in only more affluent families being able to take advantage of this program. Identification of alternative funding or additional financial arrangements is needed for if this program is to be clinically sustainable.

Preliminary outcome results suggest positive changes in both child and parents from participation in the SAFE PLACE program. Significant changes in understanding of their child, ability to utilize new strategies when dealing with challenging behaviors, and increased awareness of personal sensory and coping styles were reported by the parents. In the child, the best changes were found in sensory and motor skills, which is expected given the sensory-based nature of the intervention. Lesser behavioral and social skills changes were observed with few, if any noted changes in functional performance, except those identified in goal attainment scaling. It is likely that a 12-week intervention is too brief to result in significant functional life tasks. The outcome measures used in this study were sensitive to change when the child had identified problems in an area. Similarly, the use of primarily parent-report measures for social, behavioral and functional skills (those areas that showed the least change) may be less than optimum. Identification of additional observational or administered assessments is recommended.

As a program review, this study reflected the strengths and weaknesses of research in clinical practice. Feasibility challenges identified in this program review can inform future research. The small sample size of a single subject limits generalizability, particularly in regard to outcomes, but was believed by the researchers and clinical staff involved to reflect the feasibility challenges of implementing this intense intervention in a clinical setting. Use of an assessment therapist who was not involved in the intervention was an attempt to decrease bias in objective assessment, but in the clinic setting total blinding was not possible as part of the program review process. Similarly, parent involvement in the intervention may bias parent report outcomes but was unavoidable and undesirable in a clinical setting. These issues, as well as potentially, use of a control group, random assignment to groups, etc. would need to be addressed in a formal intervention study.

Conclusions

The SAFE PLACE program is an intensive, safe and acceptable interdisciplinary program that demonstrates promising outcomes for children with sensory processing challenges and trauma/attachment concerns and their families. Clinical application of the program is possible but scheduling and finances present potential barriers to routine implementation. The next step in the development of the SAFE PLACE program is to conduct a larger, full scale feasibility and fidelity study with approximately ten participants. This sample size will provide more information on the feasibility of conducting a pilot intervention study and also further inform the feasibility of implementing this program in a clinical setting as a routine clinical intervention.

Funding

This study was funded by OTA the Koomar Center who employed the first author to develop and study the Safe Place program.

Compliance with Ethical Standards

The first author was hired to develop the SAFE PLACE program and conduct this study. The second author was a research assistant on the study. The study was approved by the Spiral Foundation Institutional Review Board. Parental informed consent and permission to video record intervention sessions was obtained.

Conflict of Interest

The first author, Dr. Teresa May-Benson, Executive Director of the Spiral Foundation, was employed by OTA the Koomar Center to develop the SAFE Place program and to conduct this study as Principle Investigator. Dr. May-Benson has received financial support for travel expenses from OTA the Koomar Center to present this research at various conferences. The second author, Alison Teasdale is an employee of the Spiral Foundation and participated in conducting this research.