Parent-Based Intervention for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)

This study aims to test the efficacy of a parent-based approach to treating Avoidant/Restrictive Food Intake Disorder (ARFID) in children, SPACE-ARFID (Supportive Parenting for Anxious Childhood Emotions, adapted for ARFID), by comparing it to Nutritional Support (NS). The study design is a randomized controlled trial with 2 treatment arms and 3 assessment points (pre, post, and follow-up) using questionnaire data and clinical interviews.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety Disorder of Adolescence; Avoidant / Restrictive Food Intake Disorder
• Intervention / Treatment: Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE); Behavioral: Nutritional Support (NS)

Detailed Description

The primary objective is to examine if SPACE-ARFID is more efficacious than NS in reducing adolescent ARFID symptoms. The secondary objective is to examine if SPACE-ARFID produces greater change than NS in improving family accommodation and family functioning. SPACE and NS will be delivered over 16-20 weekly sessions, pre-assessment will take place before sessions begin and post-assessment will take place once sessions end, there will also be a midpoint assessment halfway through treatment (sessions 8-10) and one more follow-up assessment 6 months later.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alison Magnotti, MA; Phone Number: 203-737-4644; Email: alison.magnotti@yale.edu
• Study Contact Backup: Name: Eli Lebowitz, PhD; Phone Number: 203-737-4644; Email: eli.lebowitz@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale Child Study Center
      • Contact: Eli Lebowitz, PhD; Phone Number: 203-737-4644; Email: eli.lebowitz@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be between 6 and 12 years old.
• Meet DSM-5 diagnostic criteria for ARFID, as determined by the PARDI diagnostic interview.
• Cease all other psychotherapeutic treatment targeting eating or feeding behaviors, upon consultation with project staff and the current service provider.
• Not currently use any psychotropic medication, unless on a stable dose for a minimum of 4 weeks prior to enrollment; no changes anticipated during the course of the study.
• BMI at or above the 5th percentile for age and sex.
• Have an eligible and willing participating parent (see parent exclusions below).

Exclusion Criteria:

Adolescents:

• Meet criteria for any other DSM-5 disorder as determined by the ADIS diagnostic interview and health history form, that is sufficiently impairing or disruptive so as to make treatment focused on ARFID not feasible.
• Have any of the following disorders: intellectual disability; bipolar disorder; schizophrenia and other psychotic disorders; and alcohol and substance use disorders, as determined by the health history form.
• Report a suicide attempt in the last 3 months, or current suicide intent and/or plans.
• Be a victim of past or present undisclosed abuse requiring investigation or ongoing supervision by the Department of Children and Families.
• Not have sufficient proficiency in English to complete assessments.
• Require a level of medical care for nutritional compromise that exceeds what can be safely provided in an outpatient setting.

Parents:

• Have any of the following: intellectual disability; untreated bipolar disorder; untreated schizophrenia and other psychotic disorders; and untreated alcohol and substance use disorders, report a suicide attempt in the last 3 months, or current suicide intent and/or plans.
• Not be living with the child at least 50% of the time.
• Not have sufficient proficiency in English to complete assessments and participate in treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Parenting for Anxious Childhood Emotions (SPACE); Parent-only approach to treating anxiety disorders in adolescents delivered over 16-20 sessions.	Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE); Parent-based treatment delivered by therapist for 16-20 weekly sessions.
Active Comparator: Nutritional Support (NS); Parent-only approach comparator arm delivered over 16-20 sessions.	Behavioral: Nutritional Support (NS); Nutritional Support from Registered Dietician for 16-20 weekly sessions with parents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pica, ARFID, and Rumination Disorder Interview (PARDI-C/P)	This semi-structured clinical interview will assess ARFID presence and severity. Symptoms are rated on a 0 (no symptoms) to 6 (severe symptoms) scale. It yields an overall severity score and three profile scores (sensory sensitivity, lack of interest in eating or food, fear of aversive consequences). Score range = 0 to 6 with higher scores indicating greater severity.	Weeks 1 and 16-20
Nine-Item Avoidant/Restrictive Food Intake Disorder Screen - Parent and Child Report (NIAS-C/P)	This measure is a screener of ARFID severity. It contains 9 items, each rated on a 6-point scale from 0 ("strongly disagree") to 5 ("strongly agree"). It yields a total score and three subscale scores (picky/selective eating, poor appetite/limited interest, fear of negative consequences). Total score range = 0 to 45, with higher scores indicating greater severity.	Weeks 1, 8-10, 16-20 and 6 months later
Clinical Global Impression Scale - Severity (CGI-S) and Improvement (CGI-I)	This measure will be used to assess overall severity (CGI-S) and improvement (CGI-I) in adolescent ARFID. Total score range for each is 1-7. (Scores of 1 ("very much improved/normal") or 2 ("much improved/borderline ill") indicate a positive treatment response; all other responses are considered negative responses. Higher scores indicate worse outcome.	Weeks 1 and 16-20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Food Neophobia Scale - six item version (CFNS-6)	This measure of children's reluctance to try new or unfamiliar foods contains 6 items rated on a 4-point scale from 1 ("strongly disagree") to 4 ("strongly agree"), with 2 items reverse-scored. Total score range = 1 to 24, with higher scores indicating greater food neophobia.	Weeks 1, 8-10, 16-20 and 6 months later
Caregiver Strain Questionnaire (CGSQ)	This scale will measure the strain caregivers experience as a result of their child's emotional and behavioral problems. It contains 21 items, each rated on a 5-point scale from 1 ("not at all a problem") to 5 ("very much a problem") for how much each occurrence or feeling was a problem in the past 6 months. The items form three subscales: objective strain (11 items), subjective internalized strain (6 items), and subjective externalized strain (4 items). Subscale and global scores are item means, 1 item ("relating well to child") is reverse scored. Scores range = 1 to 5, with higher scores indicating greater strain.	Weeks 1, 8-10, 16-20 and 6 months later
Parent-Rated Food Flexibility Scale (FFS)	This scale is a 10-item parent-report measure of the child's tolerance of variability across food-related domains. Parents rate each domain on a 5-point scale from 0 ("very inflexible") to 4 ("very flexible"), with "mostly inflexible" (1), "some flexibility" (2), and "mostly flexible" (3) in between. Ratings are summed to a total score (range = 0 to 40), with higher scores indicating greater flexibility.	Weeks 1, 8-10, 16-20 and 6 months later
Acceptance and Confidence Scale - Anxiety	This scale is a measure of the extent to which parents express acceptance of and confidence in the face of their child's anxiety, a key clinical target of SPACE. It contains 8 items, each rated on a 6-point scale from 1 ("strongly disagree") to 6 ("strongly agree"). Total score range = 8 to 48, with higher scores indicating greater acceptance and confidence.	Weeks 1, 8-10, 16-20 and 6 months later
Weekly Food Update	This brief questionnaire tracks changes in the child's eating over the course of treatment. Parents complete it before each weekly session, thinking back over the past week. The form has two parts. In the first, parents indicate whether their child ate each food already being tracked, and if so, how much (a taste, some, or a full portion), and whether the child now eats it regularly. In the second, parents record foods that are new that week: foods the child has never eaten before, foods the child is eating again after a long period of avoidance, and familiar foods eaten in a new way (for example, a different brand, preparation, or setting).	Weeks 1-20
Parent-completed Glasgow Sensory Questionnaire, short form (rGSQ-P)	This scale has 24 items and measures children's sensory hyper- and hypo-sensitivity across six sense domains (visual, auditory, gustatory, olfactory, tactile, vestibular). Parents rate items on a 5-point scale from 0 ("never") to 4 ("always"), yielding total (0-96), hyper-sensitivity (0-48), and hypo-sensitivity (0-48) scores, with higher scores indicating greater sensory sensitivity.	Weeks 1, 8-10, 16-20 and 6 months later
Client Satisfaction Questionnaire (CSQ-8)	This 8-item measure assesses client satisfaction. Parents and adolescents rate items on a 0-4 scale, with higher summed scores indicating greater satisfaction with services (range = 0 to 32).	Week 16-20

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family Accommodation Scale - Anxiety (FASA-C/P)	This scale is a widely used measure of family accommodation. Adolescents and parents rate 9 items on a 5-point scale from 0 ("never") to 4 ("daily"). Total score range = 0 to 36.	Weeks 1 and 16-20
Family Assessment Device - General Functioning Scale (FAD-GF)	This scale measures overall family functioning. Adolescents and parents rate 12-items on a 4-point scale from 0 ("strongly disagree") to 3 ("strongly agree"). Total score range = 0 to 36.	Weeks 1 and 16-20

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Eli Lebowitz, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: October 29, 2026
• First Submitted That Met QC Criteria: October 29, 2026
• First Posted (Actual): November 4, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: October 29, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Avoidant Restrictive Food Intake Disorder; Therapeutics; Nutrition Therapy; Nutritional Support
• Other Study ID Numbers: 2000044082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No