Avoidant/Restrictive Food Intake DisorderNCT04450771
Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID
A study testing Family-based Treatment for ARFID in people with Avoidant/Restrictive Food Intake Disorder, run by Stanford University at 1 site in United States.
Trial summary
This study is examining the efficacy and mechanism of family therapy compared to usual care for children between the ages of 6 and 12 who are diagnosed with Avoidant/Restrictive Food Intake Disorder. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Avoidant/Restrictive Food Intake Disorder
- What is being tested?
- Family-based Treatment for ARFID
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 16 Jan 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children meeting DSM-V criteria for ARFID
- Children between the ages of 6 to 12 years old, living with their families
- Medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine.
- Not engaging in another individual or family-based psychotherapy trial during the duration of treatment sessions in the study.
- Less than 4 sessions of FBT
- If taking medication for co-morbid disorders, participants must be on a stable dose of medication for 8 weeks (2 months) before participating. If the participant is on a new medication at baseline, but is discontinuing the medication in order to start the study, they must have discontinued the medication before beginning treatment.
- EBW between 75% and 88%.
- Able to fluently speak and read English
Who cannot join
- Current physical, psychotic illness or other mental illness requiring hospitalization
- Current psychotic illness or mental retardation or other mental illnesses that would prohibit the use of psychotherapy
- Current dependence on drugs or alcohol
- Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
- Any medical complications or severe mental disorder (psychosis, low-functioning Autism) that may reduce compliance with the study procedures or require more intensive care to manage the symptoms
- 4 or more sessions of FBT
Show all 13Show fewer
- Currently taking medication for co-morbid disorders that cannot be safely discontinued or prescribed for less than 2 months
- Medically unstable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine, defined as: vital sign instability (heart rate less than 45 beats per minute), clinically significant orthostatic blood pressure with changes usually greater than 35 points or findings of gastrointestinal bleeding, dizziness, or syncope, IBW <75%, hypothermia (body temperature less than 36 degrees centigrade), clinically significant electrolyte abnormalities, or prolonged QTc on electrocardiogram
- Expected Body Weight (EBW) <75% or > 88%
- Unable to fluently speak and read English
- Parent excluded
- Suicidal
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight Avoidant/Restrictive Food Intake Disorder (ARFID)
This study is examining the efficacy and mechanism of family therapy compared to usual care for children between the ages of 6 and 12 who are diagnosed with Avoidant/Restrictive Food Intake Disorder. Preliminary data suggest that family therapy is superior to usual care and that improvement in parental self-efficacy related to feeding their children is the mechanism of treatment. In addition, this study will attempt to identify specific patient groups who respond to family therapy.
Read the detailed description
Potential subjects aged 6 years to 12 years, 11 months old with DSM 5 ARFID, and weight equal to or between 75 to 88% EBW who are medically stable for outpatient treatment and their families will be recruited through Stanford University, pediatricians, mental health experts, clinics treating EDs, and local parents' groups. Those eligible for the program will be invited to read and sign informed consent forms and complete the baseline assessment. Participants will then be randomized to FBT-ARFID with medical management for 14 sessions provided over 4 months or manualized Non-Specific Care (NSC) with medical management for 4 months. NSC will consist of 14 sessions over 4 months.
There will be 5 major assessment time points: Baseline, 1 month, 2 months, End Of Treatment (4 months), and 6-month post-treatment Follow-Up. Both the child and the parent will complete measures at these time points. In addition, parents will complete short survey assessments after each of the 14 treatment sessions.
- Being tested
- Family-based Treatment for ARFID, Manualized Non-Specific Usual Care for ARFID
- Keywords
- FBT, Family Based Treatment, ARFID
- Medical subject headings
- Avoidant Restrictive Food Intake Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based Treatment for ARFIDBehavioural
Also called FBT-ARFID
This treatment includes 14 1-hour sessions that will be conducted approximately weekly over a 4 month period. It is a manualized treatment based on the model of FBT that employs the same interventions as standard FBT for AN and BN: externalization, agnosticism, parental empowerment, a behavioral focus on changing eating behavior.
Manualized Non-Specific Usual Care for ARFIDBehavioural
Also called NSC
This treatment is a manualized non-specific psycho-educational and motivational enhancement approach that is based on a supportive non-directive psychotherapy model. It consists of sessions with the child alone and 5 parent-only meetings, all of which are 1-hour over a 4 month period.
| Study group | Role | What they receive |
|---|---|---|
| Family-based Treatment for ARFID(FBT-ARFID) | Experimental | FBT-ARFID is a manualized treatment based on the model of FBT that employs the same interventions as standard FBT for AN and BN: externalization, agnosticism, parental empowerment, a behavioral focus on changing eating behavior. Early sessions focus on inciting parents to make changes and include a family meal that allows therapists to observe \& consult directly to mealtime behaviors. FBT-ARFID for children 12 and under is manualized and consists of 2 phases. The first phase is focused on parents taking charge \& changing the eating behaviors of their child that are maintaining ARFID. The second phase focuses on the child taking up in an age-appropriate way managing their eating consistent with the changes the parents have employed in phase 1. Fourteen 1-hour sessions will be conducted approximately weekly over 4 months. Throughout medical monitoring and weekly dietary consultation are available to the family. Receives: Behavioral: Family-based Treatment for ARFID |
| Manualized Non-Specific Usual Care for ARFID(NSC) | Active comparator | A manualized non-specific psycho-educational and motivational enhancement approach that is based on a supportive non-directive psychotherapy model that has been used in other RCTs with eating disorders as a comparison. NSC consists of sessions with the child alone and 5 parent-only meetings. Sessions are 1-hour. NSC matches FBT-ARFID for time and therapist attention. The focus of the NSC intervention is psychoeducation about health \& social impacts of restrictive eating and supporting parent \& child exploration of motivation to change eating patterns \& choices they make about changes to eating. The therapist does not initiate behavioral or cognitive interventions. Feelings about eating and making changes are explored in both the child and parent sessions. Medical and dietary advice are provided weekly. Receives: Behavioral: Manualized Non-Specific Usual Care for ARFID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expected Body Weight (EBW)
Expected Body Weights (EBW) percentages used will be calculated using Center for Disease Control Growth Chart metrics in children and adolescents with weight adjusted for age, gender, and height.
Measured: 4 months
Parents Versus Avoidant/Restrictive Food Intake Disorder (ARFID)
A modification of the Parents versus Anorexia Nervosa Scale, a measure of parental self-efficacy at changing eating behaviors. The modifications to the scale are minor and consisted of changing the name of the disorder named in the scale's questions from AN to ARFID. This is a 7 item 5 point scale (for an overall score range of 7 to 35), where higher scores mean greater parental self-efficacy.
Measured: 4 months
Parental Feeding Behavior Assessment
Meals are recorded by video and then coded for behaviors associated with successful re-feeding using a procedure developed for Family Based Treatment. Criticisms were counts of critical comments to the child. Warmth was counts of positive comments to the child. Physical behaviors were counts of non-verbal praise and support to eat such as rubbing the child's back or loading the child's fork. Directives were counts of direct statements to the child to eat, try a food, or take a bite. Indirectives were statements to the child suggesting that they eat, try a food, or take a bite.
Measured: Baseline and week 6
Secondary outcomes (13)
The Pica, ARFID, Rumination Disorder Interview (PARDI)
The Pica, ARFID, Rumination Disorder Interview (PARDI) is a semi-structured interview designed to diagnose and evaluate symptom severity of Avoidant/Restrictive Food Intake Disorder (ARFID). Parents reported on their child's behavior using the PARDI. The severity score is comprised of 17 items on a 7 point scale (for an overall score range of 0 to 6), where greater scores indicate greater ARFID symptom severity.
Measured: All assessment time points (Baseline, 1 month, 2 months, 4 months, and 10-months)
Therapy Suitability and Patient Expectancy (TSPE)
The Therapy Suitability and Patient Expectancy Scale is a measure with two subscales (Suitability and Success) and 2 items on 11 point scale (for an overall score of 0 to 10 on each subscale) that measures perceptions of the suitability and expectancy of the treatment provided and will be rated by parents. Higher scores on the subscales indicates greater perceptions of suitability and success. There is no TSPE total score.
Measured: At the end of session 1 (approximately 1 week following baseline), and end of sessions 3, 5, 7, 9, 11, and 13.
Parenting Style Questionnaire (PSQ)
The Parenting Style Questionnaire is a 30 item 6 point validated measure of parenting style related to authoritative, authoritarian, and permissive style. This questionnaire is divided up into three subscales: authoritative (13 questions), authoritarian (13 questions), and permissive (4 questions). Each question was rated on a scale of 1 to 6. Item scores in each subscale were summed and averaged to create the subscale score (range: 1 to 6). For all question and subscale scores, greater scores suggest the more preferred parenting style. This questionnaire will be completed by parents/caregivers.
Measured: Completed at baseline and 4 months
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
The Center for Epidemiological Studies Depression Scale for Children is a 20-item 4 point self-report scale (for an overall score range of 0 to 60) that measures child depression, with higher scores suggesting greater depressive symptoms.
Measured: Completed by children at all major assessment timepoints (Baseline, 1 month, 2 months, 4 months, and 10-months).
Revised Children's Manifest Anxiety Scale (RCMAS-2) Short
The Revised Children's Manifest Anxiety Scale Short is a 10 item 2 point scale (for an overall score range of 0 to 10) and is a validated measure of childhood anxiety and will be completed by children, with higher scores suggesting greater anxiety symptoms.
Measured: Completed by children at all major assessment timepoints (Baseline, 1 month, 2 months, 4 months, and 10-months).
Helping Alliance Questionnaire (HAQ)
The HAQ is an 11-item survey, each item scored on a 6 point scale (scores of -3, -2, -1, 1, 2, 3). This questionnaire measures the quality of the therapist-patient relationship. The form is divided up into two subscales: Helpfulness (5 questions for an score range of -15 to 15) and Cooperation (6 questions for a score range of -18 to 18). For each subscale, higher scores correspond to a more positive relationship and perception of the therapist's helpfulness and cooperation. The HAQ will be completed by parents/caregivers.
Measured: Completed by parents after treatment sessions 1, 3, 5, 7, 9, 11, and 13, and at major assessment points at 1 month, 2 months, 4 months, and 10-months.
Number of Participants With Disorders Identified Using the Schedule for Affective Disorders and Schizophrenia for School-Aged Children (6-18 Years) (K-SADS)
The Schedule for Affective Disorders and Schizophrenia for School-Aged Children (K-SADS) is a widely used semi-structured interview detecting psychiatric disorders in children and adolescents. The individual items are scored on a 0 to 3 point rating scale, with scores of a 3 representing threshold criteria that leads to an additional diagnostic supplement based on the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria evidence of the disorder. The K-SADS was administered to ascertain co-morbid psychiatric diagnoses prior to starting treatment.
Measured: Completed by parents on behalf of their child at baseline.
Strengths and Difficulties Questionnaire (SDQ)
The Strengths and Difficulties Questionnaire assesses conduct, social, and peer behaviors consists of 25 items (questions) each rated on a scale from 0 to 2. The SDQ has with 5 subscales (emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship, and prosocial behavior). Each subscale consists of 5 questions resulting in a subscale score range of 0-10 (higher scores scores correspond to greater difficulties, except for prosocial behavior, where higher scores correspond to fewer difficulties). The total difficulties score is generated by summing scores from all the subscales except prosocial behavior, to create an overall score range of 0-40, where higher scores mean greater difficulties.
Measured: Completed by parents at all major assessment points (Baseline, 1 month, 2 months, 4 months, and 10-months).
Beck Depression Inventory (BDI)
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a 4-point scale (overall scores ranging from 0 to 63). This measure also includes questions about suicidal ideation and intent. Higher scores suggest greater depressive symptoms.
Measured: Completed by parents at baseline and 4 months
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory consists of 21 self-reported items assessing a participant's anxiety symptoms on a 4-point (0 to 3) scale (for an overall score range of 0 to 63), where higher scores suggests greater anxiety symptoms.
Measured: Completed by parents at baseline and 4 months.
36-Item Short Form (SF-36)
The 36-Item Short Form is a 36 item scale and is a general measure of physical and mental health functioning. This form is divided up into 8 subscales: vitality (4 questions), physical functioning (10 questions), bodily pain (2 questions), general health perceptions (5 questions), physical role functioning (4 questions), emotional role functioning (3 questions), social role functioning (2 questions), and mental health (5 questions). 1 question is not included in subscale scoring. The questions range between 2 and 6 points (1 to 2, 1 to 3, 1 to 5, and 1 to 6) and then are each re-coded (scale of 0 to 100), summed, and averaged to create the subscale score (score range of 0 to 100). For all subscales scores, greater scores suggest less disability. This assessment will be taken by the parents/caregivers.
Measured: Completed by parents at baseline
Bandura's General Self-Efficacy Scale (GSES)
Bandura's General Self-Efficacy Scale is a 10-item 4 point self-report scale (for an overall score range of 10 to 40) of general self-efficacy, where higher scores mean higher self-efficacy. This measure was completed by parents for their general self-efficacy score.
Measured: Completed by parents at all major assessment time-points (Baseline, 1 month, 2 months, 4 months, and 10-months) as well as after each of the 14 weekly treatment sessions.
Parental Sense of Competence Scale (PSOC)
The Parenting Sense of Competence Scale contains 17 items measuring a participant's sense of competence in their parenting skills and as a parent of a child on a 6 scale (for an overall score range of 17 to 102), with higher scores meaning greater parental efficacy.
Measured: Completed by parents at all major assessment time-points (Baseline, 1 month, 2 months, 4 months, and 10-months) as well as after each of the 14 weekly treatment sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Dec 2020
- Primary completion13 Jul 2025
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Avoidant/Restrictive Food Intake DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, James Dale Lock, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450771
- Sponsor's protocol ID
- 56878
- Other IDs
- R01MH121292
- Status last verified
- Aug 2026
- First submitted
- 22 Jun 2020
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lock J, Matheson B, Jo B, Bohon C, Datta N, Whyte A, Boyce H, Gurcan HY, Cogburn AE, Kim B. Family vs Individual Treatment for Children With Avoidant/Restrictive Food Intake Disorder: A Randomized Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2026 Apr 20:S0890-8567(26)00150-4. doi: 10.1016/j.jaac.2026.04.007. Online ahead of print.
PubMed 42019720Van Wye E, Matheson B, Citron K, Yang HJ, Datta N, Bohon C, Lock JD. Protocol for a randomized clinical trial for Avoidant Restrictive Food Intake Disorder (ARFID) in low-weight youth. Contemp Clin Trials. 2023 Jan;124:107036. doi: 10.1016/j.cct.2022.107036. Epub 2022 Nov 29.
PubMed 36460266