Table 3.
| Domains/Outcomes | Measure | Description of Measure | Respondent | Time point administered |
|||
|---|---|---|---|---|---|---|---|
| BL | End | 3-m | 6-m | ||||
| Primary Outcomes | |||||||
| Pain-related Fear and Avoidance | Fear of Pain Questionnaire (FOPQ-C) | Assesses fear of pain (11 items) and avoidance of activities (13 items). | Adolescent | x | x | x | x |
| Photograph Series of Daily Activities (PHODA-YE) | 50-item measure of photographs of activities (activities of daily living, physical activities, social activities) where adolescents rate the worry and anticipated pain associated with each activity by dragging the photograph along a ‘thermometer’ ranging from 0 to 10. | Adolescent | x | x | x | x | |
| Secondary Outcome | |||||||
| Functional Disability | Functional Disability Inventory (FDI) | 15-item measure assessing perceived difficulty in performing activities in school, home, physical, and social contexts. | Adolescent | x | x | x | x |
| Additional Outcomes: Child | |||||||
| Pain | Numeric Rating Scale | Patients rate their “typical or usual pain” and “current pain” on a standard 11-point numeric rating scale (0 = “no pain” to 10 = “most pain possible”) | Adolescent | x | x | x | x |
| Pain Catastrophizing | Pain Catastrophizing Scale, Child version (PCS-C) | 13-item measure assessing negative cognitions associated with pain. | Adolescent | x | x | x | x |
| Pain Acceptance | Chronic Pain Acceptance Questionnaire for Adolescents-8 (CPAQ-A8) | 8-item measure assessing pain acceptance in the adolescent. | Adolescent | x | x | x | x |
| School Functioning | Pediatric Quality of Life-School Functioning (PedsQL) | 5-item subscale of the PedsQL assessing school functioning, including school absences, ability to concentrate, and keeping up with assigned work. | Parent | x | x | x | x |
| Additional Outcomes: Parent | |||||||
| Psychological Flexibility | Parent Psychological Flexibility Questionnaire (PPFQ-10) | 10-item measure assessing parent ability to accept their distress and respond flexibly to their child's pain. | Parent | x | x | x | x |
| Pain Acceptance | Chronic Pain Acceptance Questionnaire (PPAQ) | 15-item measure assessing parent acceptance of their child's pain. | Parent | x | x | x | x |
| Pain-related Fear and Avoidance | Parent Fear of Pain Questionnaire (PFOPQ) | 23-items assessing parent fear and avoidance behavior associated with their child's pain experiences. | x | x | x | x | |
| Pain Catastrophizing | Pain Catastrophizing Scale- Parent Version (PCS-P) | 13-item measure assessing parents' negative cognitions associated with their child's pain. | Parent | x | x | x | x |
| Protective Behaviors | Adult Responses to Children's Symptoms | 16-item subscale assessing parent protective behavioral responses to children's pain behaviors. | Parent | x | x | x | x |
| Miscarried Helping | Helping for Health Inventory | 15-items assessing miscarried helping in parents of children with chronic pain. | Parent | x | x | x | x |
| SCED Outcomes | |||||||
| Child Daily Diary | 16-items assessing fear, avoidance, activity engagement/acceptance, pain-related distress, functioning, pain, and sleep in the last 24 h+. | Adolescent | D | D | 7-days | 7-days | |
| Parent Daily Diary | 11-items assessing distress, protective behavior, activity encouragement/acceptance, and family impact in the last 24 h+. | Parent | D | D | 7-days | 7-days | |
| Exploratory Outcomes | |||||||
| Biomechanics | Participants complete a 6-min walk test, jogging trials, and a single and double limb squat task, drop jump task. | Adolescent | x | x | n/a | n/a | |
| Physical Activity | Actigraphy | Daily mean and peak activity are collected via an Actigraphy watch [49] | Adolescent | D | D | n/a | n/a |
| Healthcare Use and Cost | Cost Diaries | Cost diaries are completed on a weekly basis and assess health care service use, out of pocket costs, support provided from family, friends and professional carers. | Parent | W | W | x | x |
| Quality of life and utility | EuroQual 5-Dimension Heath-related Quality of Life for Youth (EQ-5D-Y) | 5-item measure assessing health-related quality of life comprised of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. | Parent | x | x | x | x |
| Covariates | |||||||
| Medical History | chronic pain history and course (e.g., pain onset, duration, intensity, location, course, and current medications) | Adolescent, Parent | x | n/a | n/a | n/a | |
| Demographics | age, sex, education level and school absences, family composition, parental employment, income and sick leave, and ethnic background | Adolescent, Parent | x | n/a | n/a | n/a | |
| Readiness to Change | Pain Stages of Change Questionnaire-short form (PSOCQ-A; PSOCQ-P) | 13-item measures assessing adolescent readiness to adopt a self-management approach to chronic pain and parent readiness to support this approach. | Adolescent, Parent | x | x | x | x |
| Depression | Children's Depression Inventory (CDI-2) | 28-item measure assessing youth depressive symptoms. | Adolescent | x | x | x | x |
| Anxiety | Multidimensional Anxiety Scale for Children (MASC) | 50-item measure assessing anxiety in children and adolescents across four subscales: physical symptoms, social anxiety, harm avoidance, and separation anxiety. | Adolescent | x | x | x | x |
| Treatment Satisfaction | Pain Service Satisfaction Test (PSST) | 23-items assessing the patient and parent's experience with the intervention provided. | Adolescent, Parent | n/a | x | x | x |
| Treatment Expectancy | Treatment Expectancy and Creditability (TEC) | 6-items assessing expectations related to the effectiveness and benefits from the intervention received. | Adolescent, Parent | n/a | S1 | n/a | n/a |
| Treatment Adherence | daily diary completion, percentage of patients who drop out prior to treatment completion, and percentage of sessions completed on schedule. | Researcher | n/a | x | n/a | n/a | |
| Treatment Fidelity | Fidelity checklists for presence/absence of treatment elements and treatment process are coded for all sessions across treatment arms. | Researcher | n/a | x | n/a | n/a | |
Note. +Each word in bold is a separate construct assessed on the daily diary. BL = baseline; End = Discharge; D = Daily; W=Weekly, S = session.