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. Author manuscript; available in PMC: 2024 Jan 1.
Published in final edited form as: Contemp Clin Trials. 2022 Nov 29;124:107036. doi: 10.1016/j.cct.2022.107036

Protocol for a randomized clinical trial for Avoidant Restrictive Food Intake Disorder (ARFID) in low-weight youth

Eliza Van Wye 1, Brittany Matheson 1, Kyra Citron 1, Hyun-Joon Yang 1, Nandini Datta 1, Cara Bohon 1,2, James D Lock 1,*
PMCID: PMC9839641  NIHMSID: NIHMS1854402  PMID: 36460266

Abstract

Background:

Avoidant Restrictive Food Intake Disorder (ARFID) is an eating disorder recently added to the Diagnostic and Statistical Manual, 5th Edition (DSM-5) that involves nutritional, developmental, and/or psychosocial impairment, and often presents with a lack of interest in eating, sensory-related eating concerns, and/or fear of adverse consequences related to eating. There is limited evidence on treatments for ARFID, and in particular, treatments for children in the outpatient setting. Pilot data suggest that Family-Based Treatment (FBT) modified for ARFID is efficacious, and that improvements in parental self-efficacy may be the mechanism behind its success. This manuscript describes a study protocol seeking to confirm these preliminary findings through an adequately powered, randomized clinical trial (RCT).

Methods:

This trial will randomize 100 children ages 6–12 years old who meet DSM-5 criteria for ARFID and their families to receive either 14 telehealth sessions of FBT-ARFID (n=50) or a manualized Psychoeducational Motivation Therapy (PMT) treatment (n=50), an individual therapy addressing the child’s understanding of the problems ARFID is causing and promoting non-behavioral motivation and exploration of changing their eating patterns. Masked assessments will be conducted at baseline, one and two months within treatment, end-of-treatment, and six-month follow-up. Primary outcomes include change in body weight, parental self-efficacy, and parent feeding behaviors between baseline and end-of-treatment.

Conclusions:

The results of this RCT will advance our understanding of effective treatments for low-weight ARFID in youth.

Keywords: avoidant restrictive food intake disorder, family-based treatment, eating disorders, youth, parental self-efficacy

Introduction

Avoidant Restrictive Food Intake Disorder (ARFID) is a new psychiatric disorder in the Diagnostic and Statistical Manual 5 (DSM-5) [1] with an estimated prevalence of 7.2 to 17.4 percent [2], making it a notable mental health concern. ARFID is characterized by a range of problematic eating behaviors, including a lack of interest in eating; sensory-related eating concerns (such as taste, color, or texture); and a fear of adverse consequences of eating (i.e., fear of choking or vomiting). Unlike eating disorders such as anorexia nervosa (AN) or bulimia nervosa (BN), body image and weight concerns are absent in individuals with ARFID. However, ARFID often causes significant medical and psychosocial challenges, including malnutrition, nutritional deficiencies, growth and developmental delays, family discord, and social and educational difficulties [3–5]. Despite its prevalence and potential for detrimental damage to children’s health, the literature on treatments for ARFID is sparse. Due to its relative novelty to the DSM-5, research on treatments for ARFID is largely in the exploratory phase. While there is some preliminary evidence supporting the use of cognitive behavioral therapy (CBT) for ARFID with adolescents in both inpatient and outpatient settings [6,7], there is a need for adequately powered studies testing treatments for younger children with ARFID in the outpatient setting.

Preliminary evidence suggests that Family-Based Treatment (FBT)—the first-line approach for treating AN and BN in children and adolescents, as supported by international guidelines [8–11]—modified for ARFID is a promising approach. Family-Based Treatment for ARFID (FBT-ARFID) is based on FBT for adolescent AN and BN, and uses the same strategies—externalization of the eating disorder, agnosticism, parental empowerment, and a behavioral emphasis on changing eating behavior [12]. FBT-ARFID has been explored as a potential treatment modality for three profiles of ARFID, indicating that principles of FBT can be applied across ARFID presentations (e.g., lack of interest, sensory sensitivities, fear of aversive consequences) to a pre-adolescent outpatient population [12,13]. Furthermore, preliminary data from a feasibility study comparing FBT-ARFID to Usual Care (UC) provide evidence that manualized FBT adapted for patients with ARFID is feasible and effective. Compared to children in the UC condition, children receiving FBT-ARFID gained more weight, showed greater increase in percent of their expected body weight (%EBW; for underweight children, ES= −0.90), and showed greater reduction in ARFID symptom severity (ES=0.83) between baseline and end-of-treatment [12]. Additionally, parents receiving FBT-ARFID showed larger improvements in parental self-efficacy, which was highly correlated with improvement in their child’s ARFID symptoms and weight gain (change in %EBW) [12]. These findings align with previous research, which suggests that early improvement in parental self-efficacy is a likely mechanism of FBT for other eating disorders in youth. However, adequately powered studies are needed to confirm or refute these preliminary findings and advance identification of efficacious treatments for ARFID.

This manuscript describes a randomized clinical trial for low-weight ARFID in youth ages 6–12 years old. This study aims to confirm whether FBT-ARFID is superior to a manualized specific individual therapy—Psychoeducational Motivation Therapy (PMT) for ARFID—and whether the mechanism of this effectiveness is achieved through parental self-efficacy.

Study Design

This study is a randomized controlled clinical trial funded by the NIMH (MH110538 to JL). The trial was registered in advance of recruitment on clinicaltrials.gov (NCT04450771). We will randomize 100 children ages 6–12 who meet DSM-5 criteria for ARFID and are low-weight (weigh between 75–88% of their EBW or fall at or under the 10th percentile for weight for their age and sex [14]) and their families to receive 14 telehealth sessions of either FBT-ARFID or manualized PMT as described below. Children must be medically stable for outpatient treatment and receive medical monitoring through their own treating physician throughout the study. A Data Safety and Monitoring Board consisting of study team members as well as external experts will meet annually to review study progress, data quality, treatment dropouts, study withdrawals, and any adverse events. Additionally, adverse events will be reported to the Data Coordinating Center and IRB.

Aims and Hypotheses

  • Aim 1: To conduct an RCT involving children between the ages of 6 and 12 who meet DSM-5 criteria for ARFID and are low-weight (mean %EBW between 75–88% or fall at or under the 10th percentile for weight for their age and sex [14]) comparing FBT-ARFID with medical management to manualized PMT with medical management. We hypothesize that participants randomized to FBT-ARFID will have a significantly greater change in %EBW at EOT compared to participants randomized to PMT.

  • Aim 2: To examine early change in parental self-efficacy as a mediator of treatment effect (FBT-ARFID vs. PMT on outcome). We hypothesize that positive changes due to FBT-ARFID in parental self-efficacy related to feeding behaviors using the Parents vs ARFID Scale (PvsARFID) will be associated with positive changes in %EBW at EOT. Secondarily, we will explore whether changes in parental re-feeding behavior are a possible mechanism of FBT-ARFID using a mediator analysis.

  • Aim 3: To explore moderators of treatment outcome. We will examine all baseline variables as potential predictors and/or moderators of outcome. Our exploratory hypothesis is that baseline participant age, parental self-efficacy, severity scores on the Pica, ARFID, and Rumination Disorder Interview (PARDI), psychiatric comorbidity, parenting style, and family structure are possible moderators of treatment effect on outcome (%EBW at EOT).

Participants:

We plan to recruit 100 families with children between the ages of 6–12 meeting DSM-5 criteria for ARFID, with a mean %EBW between 75–88% or fall at or under the 10th percentile for weight for their age and sex [14]. Families are randomized to receive 14 sessions of FBT-ARFID (n=50) or a manualized PMT (n=50). FBT-ARFID includes sessions with all family members of a household, while PMT treatment includes nine child-only sessions and five parent-only sessions. Sessions in both treatment conditions are held weekly via telehealth, over a period of approximately four months.

Inclusion/Exclusion Criteria:

The inclusion criteria for participants in this study are as follows: 1) A child between the ages of 6–12 who meets DSM-5 criteria for ARFID and lives with at least one parent; 2) Medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine [15]; 3) Child is not engaging in another individual or family-based psychotherapy trial throughout the course of treatment sessions in the study; 4) If the family has received previous FBT, the family has had fewer than four sessions of FBT; 5) If taking medication for comorbid disorders that affect appetite and/or weight, participants must be on a stable dose of the medication for at least 8 weeks before beginning treatment; 6) Child must either have a mean %EBW between 75–88% or fall at or under the 10th percentile for weight for their age and sex, based on CDC equations [14]; 7) Child and family members must be able to fluently speak and read English.

The exclusion criteria for this study include: 1) Any current physical, psychotic, or mental illness requiring hospitalization; 2) Psychotic illness, significant cognitive impairment, or any other mental illnesses that would prohibit the use of psychotherapy; 3) Current dependence on drugs or alcohol; 4) Physical conditions (e.g., diabetes, pregnancy) known to influence eating or weight; 5) 4 or more sessions of FBT; 6) Currently taking adjunctive medication for comorbid disorders (e.g., antidepressants) for less than 2 months that cannot be safely discontinued; 7) In the case of patients with current or a history of sexual or physical abuse by family members, perpetrators of the abuse will be excluded from treatment; 8) Active suicidality that cannot be appropriately managed on an outpatient basis.

Recruitment:

As a telehealth study, families with a child with ARFID will be recruited throughout the United States via media advertisements, including national eating disorder websites, email listservs, and social media posts. Additionally, potential participants may learn of the study through eating disorder specialists and their treating physicians. All families who express interest in the study, via email or phone, will be contacted by a research coordinator to answer several pre-screening questions to determine whether their child meets weight criteria for the study. Following the pre-screen, families will complete a phone screen to determine additional eligibility criteria before being invited to complete a baseline assessment. We anticipate a recruitment rate of 2–3 participants/month in order to reach 100 participants in four years.

Methods

After completing the phone screen, eligible families are invited to complete a baseline assessment, during which a research coordinator will obtain informed consent from parents and assent from children. Following the consent process, parents complete two interviews on behalf of their child: one interview designed to assess for psychiatric comorbidities, and another to confirm the presence of an ARFID diagnosis and assess severity of eating symptoms. Additionally, parents and children complete online questionnaires. Once the baseline assessment is complete, and the child has received medical clearance from the study pediatrician, families are randomized to FBT-ARFID or PMT and are eligible to begin treatment.

Assessments are conducted at five major timepoints (baseline; one and two months within treatment; end of treatment; and six months post-treatment) through a secure online video platform by an assessor who is masked to the randomization condition. Assessments are administered to parents only and include the collection of the child’s height and weight (from parent self-report); current medications and treatments; and assessment of ARFID symptomatology through the Pica, ARFID, and Rumination Disorder Interview (PARDI) [16]. Percent expected body weight (%EBW) will be calculated through parent-reported height and weight, and the PARDI will be used to establish or confirm an ARFID diagnosis. As part of the baseline assessment, parents will also complete the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) [17] on behalf of their child, to determine comorbid psychopathology and any psychopathology that could be exclusionary (i.e., presence of psychosis). Self-report measures for parents and patient will be collected at all major assessments and throughout treatment through online surveys.

Measures:

Primary Measures:

Percent Expected Body Weight (%EBW).

Parents will self-report their child’s height and weight at baseline and all major time points. Percent of expected body weight will be calculated using CDC equations, based on the 50th body mass index percentile [14].

Parental self-efficacy at re-feeding.

Parents will complete the Parents vs. ARFID (PvARFID) measure, a 7-item self-report measure that assesses parental self-efficacy in combatting symptoms of ARFID. This measure is adapted from the Parents vs. Anorexia Nervosa scale (PvAN) [18], which is widely used to measure parental self-efficacy in AN treatment studies. Example items include, “I don’t have the knowledge to take a leadership role when it comes to achieving a total victory over the ARFID,” with response options ranging from “1 – strongly disagree” to “5 – strongly agree.” The PvARFID is administered to parents at the end of each session and at all major assessment timepoints.

Family meal behaviors.

All families will be asked to record a family meal at baseline and after six treatment sessions. The Parental Feeding Behavior Assessment consists of two recorded family mealtimes that are coded for parental re-feeding behavior. The coding procedure has been previously used to establish predictors of AN recovery in FBT [19].

Secondary Measures:

ARFID diagnosis and severity.

Parents will complete the Pica, ARFID, and Rumination Disorder Interview (PARDI) [16], an 80-item semi-structured interview used to diagnose ARFID and assess symptom severity. The PARDI will be administered by a trained assessor at all major assessment timepoints.

Child psychopathology.

Parents will complete the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL DSM-5) [17] interview with a trained research coordinator to determine co-current child psychopathology. The KSADS is a widely used interview for detecting psychiatric disorders in children and adolescents with good psychometric properties [20].

Within-session weight.

Study therapists will collect patient weight at each treatment session, regardless of treatment arm. These measurements will be self-reported.

Perceptions of suitability and expectancy of treatment.

Parents will complete the Therapy Suitability and Patient Expectancy (TSPE) scale, which asks parents to rate the suitability and expectancy of the treatment provided using a visual analogue scale (0–10).

Parenting style.

Parents will complete the Parenting Style Questionnaire (PSQ) [21], a validated measure of parenting style related to authoritative and permissive style, at baseline and end-of-treatment.

Therapist-patient relationship.

Parents will complete the Helping Alliance Questionnaire (HAQ) [22], an 11-item questionnaire that measures the quality of the therapist-patient relationship, at all major assessment timepoints.

Child’s behavior.

Parents will complete the Strengths and Difficulties Questionnaire (SDQ) [23], a 25-item questionnaire designed to assess a child’s conduct, social, and peer behaviors, at all major assessment timepoints.

Parental depression and anxiety.

Parents will complete the Beck Depression Inventory (BDI) [24]) and the Beck Anxiety Inventory (BAI) [25] at baseline and end-of-treatment.

Parental health.

Parents will complete the 36-Item Short Form (SF-36) [26], a general measure of physical and mental health functioning, at baseline.

General parental self-efficacy.

Parents will complete Bandura’s General Self-Efficacy Scale (GSES) [27] and the Parenting Sense of Competence Scale (PSOC) [28] at all major assessment timepoints, and after every session.

Child depression and anxiety.

Children will complete the Center for Epidemiological Studies Depression Scale for Children (CES-DC) [29] and the Revised Children’s Manifest Anxiety Scale (RCMAS) [30] at all major assessment timepoints.

Randomization:

Once the baseline measures are complete, and a child has received medical clearance by the site-specific pediatrician, families will be randomized to one of two treatment arms (described below) and begin treatment. Randomization is conducted by the data coordinating center using block randomization with a block size of 8. Participants in both treatment conditions are expected to receive ongoing medical care to ensure medical stability for outpatient treatment.

Treatments:

Family-Based Treatment for ARFID (FBT-ARFID):

FBT-ARFID is a manualized treatment based on FBT for adolescents with AN and BN [31,32] and utilizes the same interventions: externalization of the illness, agnosticism, parental empowerment, and a behavioral emphasis on changing eating behavior. FBT-ARFID consists of two phases: in the first phase, parents are encouraged to take charge of their child’s eating, and includes a family meal, which allows therapists to observe and confer directly on mealtime behaviors [33]. In the second phase, the child is encouraged to take control of their own eating once again, maintaining the changes made by parents in the first phase. All family members participate in the treatment sessions.

Psychoeducational Motivation Therapy for children with ARFID (PMT):

PMT treatment for ARFID is a manualized psychoeducational and motivational enhancement approach developed for this study and age group based on similar approaches that have been used as comparisons in other eating disorder treatment RCTs [34]. PMT [35–39] consists of nine individual meetings with the child and five parent sessions. PMT provides psychoeducation about the health and social impacts of restrictive eating and supports children in their exploration surrounding motivation to change their eating patterns. In this treatment arm, the therapist does not initiate behavioral or cognitive interventions. There is no overlap with FBT-ARFID, because there are no family sessions, no discussions about weight or behavioral strategies, no monitoring of behavioral progress, no in-session family meal, and no empowerment of parents to manage the restrictive eating.

Therapist Training and Supervision:

Therapists are assigned to conduct only one type of treatment—either FBT-ARFID or PMT—but not both. Prior to initiating treatment, the study PI (JL) will conduct a two-day intensive workshop to ensure therapists are adequately trained in their respective treatment modality. Therapists will also be provided with the corresponding treatment manual. Across treatment arms, all therapists are PhD-level clinicians with experience treating children with eating disorders. Separate weekly supervision will be conducted (by JL) to address compliance with the manualized approaches, ensure no overlap in interventions occurs, address pressing clinical concerns, and support proper implementation of both treatment modalities.

Therapeutic Adherence and Treatment Fidelity:

Once the study is completed, 20% of recorded treatment sessions will be randomly selected. Independent coders will rate sessions using specialized fidelity measures designed for the treatments in this study. An assessor trained by Dr. Lock and masked to treatment allocation will assess fidelity to FBT-ARFID using video or audiotapes of sessions 1–4 on a random sample of 20% of the recordings, employing the standardized fidelity measure focused on early FBT treatment [40].

Proposed Statistical Analyses

Our main statistical analysis will employ longitudinal mixed-effects modeling to test treatment effects, comparing FBT-ARFID to PMT. This method will allow us to utilize repeated measures of primary and secondary outcomes. Specifically, in Aim 1, we will use a random intercept/slope model with and without conditional on relevant covariates that are potential predictors of %EBW. If the trajectory shape is nonlinear, we will apply polynomial growth models. Power calculations suggest that our proposed sample of N=100 will be adequately powered at B=0.84 (alpha=0.05, two-tailed) to detect a medium effect size (d=0.5) difference in %EBW between the two treatment conditions at end-of-treatment. In Aim 2, we will examine whether earlier change (from baseline to six weeks) in parental self-efficacy mediates the effect of treatment on %EBW using the MacArthur model for mediator analysis [41]. Mediator assessment will occur at baseline and every two weeks during the first six weeks of treatment to allow detection of change in parental self-efficacy prior to outcome. Sensitivity analyses will be conducted using modern causal mediation approaches that utilize potential outcomes and propensity scores [42–45]. We will also explore whether parental re-feeding behavior during mealtimes is a possible mediator by examining changes in coded mealtime behavior from baseline to six weeks. Mixed-effects modeling will examine associations between parental self-efficacy, mealtime behavior, and %EBW throughout the study to complement mediation analysis. In Aim 3, we will use the MacArthur framework to explore potential moderators of treatment effect such as age, parental self-efficacy, ARFID severity, psychiatric comorbidity, and family structure [41]. All analyses will be intent-to-treat with missingness assumed at random. We will use SPSS 28 and specialized statistical programs as necessary to conduct these analyses.

Discussion

This study aims to assess whether Family-Based Treatment modified for ARFID (FBT-ARFID) is superior to PMT for children with low-weight ARFID, and whether its success is achieved through enhancing parental self-efficacy at re-feeding. More importantly, this study seeks to address an important unmet need: the advancement of outpatient treatments for children with low-weight ARFID. As FBT is esteemed as the gold-standard treatment for both adolescent AN and BN, if this study reveals that FBT can successfully treat children with ARFID, FBT could be used as a transdiagnostic approach across eating disorders [46].

Strengths of the study include the utilization of videoconferencing platforms that allow for national recruitment and increased access to care. Additionally, as assessors can determine whether children meet DSM-5 criteria for ARFID through the Pica, ARFID, and Rumination Disorder Interview (PARDI) [16], participants are not required to have previously been diagnosed with ARFID, broadening the accessibility of the study and its treatments to more families. Furthermore, all study therapists are expert psychotherapists with specialized training in the treatment of eating disorders, including ARFID, in children and adolescents. Therapists are assigned to deliver treatment in only one arm of the study to limit cross-contamination effects of the interventions. This is a one-site study, and thus site effects are not a concern. However, due to the inability to conduct assessments and treatment in languages other than English, families may be excluded on this basis, which could limit the diversity of the sample and thus impact the generalizability of the research findings. Additionally, the study is designed for participants with low-weight ARFID only and may not pertain to normal weight ARFID presentations. Future research studies may consider eliminating weight-based inclusion criteria to test treatment options for a wider range of ARFID presentations.

Because patients with ARFID do not have shape and weight concerns, but instead have problematic eating behaviors related to poor appetite, eating with sufficient variety, and fear of the consequences of eating related to pain, choking, or vomiting, FBT may be a particularly apt treatment approach for this group. This study focuses on a younger age group (6–12-year-olds) than has been the case for AN and BN RCTs. This will add to the knowledge about the usefulness of FBT in this age group, for which parental management of eating is developmentally expected. Further, the approach is for outpatients, and is of relatively short duration and intensity, potentially making it a scalable intervention. Evidence suggests that for adolescent AN and BN, FBT can be disseminated [31,32]. Thus, if this study finds FBT effective for ARFID as it is for AN and BN, FBT may become an evidence-based transdiagnostic [46] approach for eating disorders in youth, allowing therapists to utilize a single approach across several eating disorders in children and adolescents. Results of this study, regardless of outcome, will clarify whether FBT-ARFID should be studied in effectiveness and/or dissemination and implementation studies in the future, and whether the mechanism of treatment effect is confirmed and possibly generalizable to other family treatments.

Acknowledgements

This work is supported by the National Institute of Mental Health [NIMH110538]. The authors would also like to thank the children and their families for their participation in the study.

Abbreviations:

ARFID

Avoidant Restrictive Food Intake Disorder

FBT

Family-Based Treatment

FBT-ARFID

Family-Based Treatment for ARFID

PMT

Psychoeducational Motivation Therapy

%EBW

percent expected body weight

EBW

expected body weight

Footnotes

Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Author Disclosure Statement: JDL is the author of Family-based Treatment for Avoidant Restrictive Food Intake Disorder.

Trial Registration: The trial was registered in advance of recruitment on clinicaltrials.gov (NCT04450771).

Declaration of interests

JL receives royalties from Guilford Press and Routledge. He also is co-director of the Training Institute for Child and adolescent Eating Disorders, LLC. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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