An interventional study of Supportive Parenting for Anxious Childhood Emotions (SPACE) and Nutritional Support (NS) in Anxiety Disorder of Adolescence and Avoidant / Restrictive Food Intake Disorder, sponsored by Yale University. Not yet recruiting at 1 site in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
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.
40 studies on the registry are indexed under Avoidant Restrictive Food Intake Disorder; 12 are open to participants now.
This study's planned enrollment of 110 is above the median of 38 across 28 interventional studies indexed under Avoidant Restrictive Food Intake Disorder.
Browse Avoidant Restrictive Food Intake Disorder studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
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Exclusion Criteria:
Adolescents:
Parents:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Parent-only approach to treating anxiety disorders in adolescents delivered over 16-20 sessions.
Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE)
Parent-only approach comparator arm delivered over 16-20 sessions.
Behavioral: Nutritional Support (NS)
Parent-based treatment delivered by therapist for 16-20 weekly sessions.
Nutritional Support from Registered Dietician for 16-20 weekly sessions with parents.
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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 1 and 16-20
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: Week 16-20
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.
Time frame: 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.
Time frame: Weeks 1 and 16-20
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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