Anxiety Disorder of AdolescenceNCT07916974
Parent-Based Intervention for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
A study testing Supportive Parenting for Anxious Childhood Emotions (SPACE) and Nutritional Support (NS) in people with Anxiety Disorder of Adolescence and Avoidant / Restrictive Food Intake Disorder, run by Yale University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Anxiety Disorder of Adolescence, Avoidant / Restrictive Food Intake Disorder
- What is being tested?
- Supportive Parenting for Anxious Childhood Emotions (SPACE) and Nutritional Support (NS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale Child Study Center
New Haven, Connecticut, 06519
Eli Lebowitz, PhD, 203-737-4644, eli.lebowitz@yale.edu
About this study
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.
Read the 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.
- Being tested
- Supportive Parenting for Anxious Childhood Emotions (SPACE), Nutritional Support (NS)
- 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.
Supportive Parenting for Anxious Childhood Emotions (SPACE)Behavioural
Parent-based treatment delivered by therapist for 16-20 weekly sessions.
Nutritional Support (NS)Behavioural
Nutritional Support from Registered Dietician for 16-20 weekly sessions with parents.
| Study group | Role | What they receive |
|---|---|---|
| Supportive Parenting for Anxious Childhood Emotions (SPACE) | Experimental | Parent-only approach to treating anxiety disorders in adolescents delivered over 16-20 sessions. Receives: Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE) |
| Nutritional Support (NS) | Active comparator | Parent-only approach comparator arm delivered over 16-20 sessions. Receives: Behavioral: Nutritional Support (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Weeks 1 and 16-20
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Week 16-20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorder of AdolescenceStudies of the same condition, open and under way.
- More trials run by Yale 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
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eli Lebowitz, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916974
- Sponsor's protocol ID
- 2000044082
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Based Intervention for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
- ClinicalTrials.gov ID
- NCT07916974
- Acronym / sponsor ID
- 2000044082
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Parenting for Anxious Childhood Emotions (SPACE) | Experimental | Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE)Parent-only approach to treating anxiety disorders in adolescents delivered over 16-20 sessions. |
| Nutritional Support (NS) | Active comparator | Behavioral: Nutritional Support (NS)Parent-only approach comparator arm delivered over 16-20 sessions. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive Parenting for Anxious Childhood Emotions (SPACE)Parent-based treatment delivered by therapist for 16-20 weekly sessions. | Behavioural | Supportive Parenting for Anxious Childhood Emotions (SPACE) |
| Nutritional Support (NS)Nutritional Support from Registered Dietician for 16-20 weekly sessions with parents. | Behavioural | Nutritional Support (NS) |
Primary outcome
Pica, ARFID, and Rumination Disorder Interview (PARDI-C/P)
Time frame: 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.
Nine-Item Avoidant/Restrictive Food Intake Disorder Screen - Parent and Child Report (NIAS-C/P)
Time frame: 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.
Clinical Global Impression Scale - Severity (CGI-S) and Improvement (CGI-I)
Time frame: 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.
7 secondary outcomes
Children's Food Neophobia Scale - six item version (CFNS-6)
Time frame: Weeks 1, 8-10, 16-20 and 6 months later
Caregiver Strain Questionnaire (CGSQ)
Time frame: Weeks 1, 8-10, 16-20 and 6 months later
Parent-Rated Food Flexibility Scale (FFS)
Time frame: Weeks 1, 8-10, 16-20 and 6 months later
Acceptance and Confidence Scale - Anxiety
Time frame: Weeks 1, 8-10, 16-20 and 6 months later
Weekly Food Update
Time frame: Weeks 1-20
Parent-completed Glasgow Sensory Questionnaire, short form (rGSQ-P)
Time frame: Weeks 1, 8-10, 16-20 and 6 months later
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Week 16-20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eli Lebowitz principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Parenting for Anxious Childhood Emotions (SPACE) and Nutritional Support (NS) in people with Anxiety Disorder of Adolescence and Avoidant / Restrictive Food Intake Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eli Lebowitz, PhD (203-737-4644, eli.lebowitz@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pica, ARFID, and Rumination Disorder Interview (PARDI-C/P) (time frame: Weeks 1 and 16-20). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.