Parent-Based Intervention for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
NCT07916974, Not applicable, Not yet recruiting, Yale University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Parent-Based Intervention for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID) | ClinicalTrials.gov |
| NCT number | NCT07916974 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 110 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Yale University | ClinicalTrials.gov |
| Conditions | Anxiety Disorder of Adolescence, Avoidant / Restrictive Food Intake Disorder | ClinicalTrials.gov |
| Interventions | Supportive Parenting for Anxious Childhood Emotions (SPACE), Nutritional Support (NS) | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Pica, ARFID, and Rumination Disorder Interview (PARDI-C/P) | Weeks 1 and 16-20 | 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. | ClinicalTrials.gov |
| Primary | Nine-Item Avoidant/Restrictive Food Intake Disorder Screen - Parent and Child Report (NIAS-C/P) | Weeks 1, 8-10, 16-20 and 6 months later | 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. | ClinicalTrials.gov |
| Primary | Clinical Global Impression Scale - Severity (CGI-S) and Improvement (CGI-I) | Weeks 1 and 16-20 | 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. | ClinicalTrials.gov |
| Secondary | Children's Food Neophobia Scale - six item version (CFNS-6) | Weeks 1, 8-10, 16-20 and 6 months later | 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. | ClinicalTrials.gov |
| Secondary | Caregiver Strain Questionnaire (CGSQ) | Weeks 1, 8-10, 16-20 and 6 months later | 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. | ClinicalTrials.gov |
| Secondary | Parent-Rated Food Flexibility Scale (FFS) | Weeks 1, 8-10, 16-20 and 6 months later | 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. | ClinicalTrials.gov |
| Secondary | Acceptance and Confidence Scale - Anxiety | Weeks 1, 8-10, 16-20 and 6 months later | 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. | ClinicalTrials.gov |
| Secondary | Weekly Food Update | Weeks 1-20 | 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). | ClinicalTrials.gov |
| Secondary | Parent-completed Glasgow Sensory Questionnaire, short form (rGSQ-P) | Weeks 1, 8-10, 16-20 and 6 months later | 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. | ClinicalTrials.gov |
| Secondary | Client Satisfaction Questionnaire (CSQ-8) | Week 16-20 | 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). | ClinicalTrials.gov |
| Other | Family Accommodation Scale - Anxiety (FASA-C/P) | Weeks 1 and 16-20 | 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. | ClinicalTrials.gov |
| Other | Family Assessment Device - General Functioning Scale (FAD-GF) | Weeks 1 and 16-20 | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
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Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)