Eating DisorderNCT05562258
Development and Testing of a Peer-Coaching Model for the Treatment of Eating Disorders
A study testing Parent Coaching and Patient Education and Parent Education and Patient Coaching in people with Eating Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This project includes developing and testing a coaching approach during the treatment of eating disorders. It is expected that with the addition of support outside of regular treatment, caregivers will experience improvements in emotional taxation and patients will strengthen skills necessary for recovery. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Eating Disorder
- What is being tested?
- Parent Coaching and Patient Education and Parent Education and Patient Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to Oct 2027
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 12 to 18 at entry to the study
- DSM-5 Diagnosis of an eating disorder
- Enrollment in treatment at the Center of Excellence for Eating and Weight Disorders Speak English
- Have access to a phone with WiFi or a data plan
- Parent and child/patient both willing to participate
Who cannot join
- Current or lifetime history of learning disorder or developmental disorder
- Acute suicide risk
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, 1 recruiting
- Recruiting
Department of Psychiatry, Eating and Weight Disorders Program
New York, New York, 10029
Jessica Bibeau, MA, 212-659-8724, jessica.bibeau@mssm.edu
Tom Hildebrandt
About this study
This project includes developing and testing a coaching approach during the treatment of eating disorders. It is expected that with the addition of support outside of regular treatment, caregivers will experience improvements in emotional taxation and patients will strengthen skills necessary for recovery. Twelve weeks of coaching will be incorporated into standard treatment. Randomization will occur placing participants into (1) parent coaching + patient educational materials or (2) parent educational materials + patient coaching.
Read the detailed description
A total of 70 adolescents with eating disorders between the ages of 12-18 and their parents/caregivers will be enrolled in a randomized-controlled trial comparing parent coaching/patient education to parent education/patient coaching. Measures will include demographics, vitals, parent and patient self-efficacy, quality of life, illness related distress/impairment, and changes in eating disorder symptoms and severity.
During a screening and consenting visit, participants will complete assessments including height, weight, demographics, and interview questions to determine inclusion/exclusion criteria and eating disorder diagnoses. At baseline, patients and parents will complete online questionnaires via a REDCap interface, measuring self-efficacy, quality of life, and illness related distress/impairment.
During the intervention, participants will attend standard therapy sessions for the treatment of eating disorders, and patients and parents will be randomized to either have access to a designated coach or weekly educational materials. Patients and parents assigned to coaching will be able to contact their coach outside of their therapy session time for 15-minute coaching calls. Completed calls will be tracked to document engagement with coaching. Patients and parents assigned to weekly education materials will receive a link, which will direct them to YouTube videos related to the skills covered in therapy for that week. They will also receive a link with a few questions to document engagement with each video.
- Coaching: A coach trained in specific skills targeted to assist in family-based therapy, will be assigned to the parent/patient to be available throughout the 12-week intervention. The coach will available between the hours of 9am - 9pm, Monday - Sunday for a brief 15-minute coaching call. During the call, the coach will remind the parent/patient of family-based skills that can be utilized in vivo to address emerging situations. If a call is running over 15 minutes, the coach will refer them to their primary therapist or emergency services.
- Educational Materials: A 2-5 minute YouTube video will be distributed to the parent/patient weekly. Videos will incorporate a new skill learned in therapy that week.
Follow-up measures will be conducted mid-way through treatment and at the end-of-treatment, and these visits will involve patients and parents repeating the assessments administered during baseline.
- Conditions
- Eating Disorder
- Being tested
- Parent Coaching and Patient Education, Parent Education and Patient Coaching
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Coaching and Patient EducationBehavioural
This group includes 12 weeks of eating disorder therapy provided to the patient. Outside of therapy, parents will have access to a coach and patients will have access to weekly educational material.
Parent Education and Patient CoachingBehavioural
This group includes 12 weeks of eating disorder therapy provided to the patient. Outside of therapy, parents will have access to weekly educational material and patients will have access to a coach.
| Study group | Role | What they receive |
|---|---|---|
| Parent Coaching and Patient Education | Experimental | This group includes 12 weeks of eating disorder therapy provided to the patient. Outside of therapy, parents will have access to a coach and patients will have access to weekly educational material. Receives: Behavioral: Parent Coaching and Patient Education |
| Parent Education and Patient Coaching | Experimental | This group includes 12 weeks of eating disorder therapy provided to the patient. Outside of therapy, parents will have access to weekly educational material and patients will have access to a coach. Receives: Behavioral: Parent Education and Patient Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eating Disorder Recovery Self-Efficacy Questionnaire (EDRSQ)
Changes in patient self-efficacy will be measured using the EDRSQ, which is a 23-item instrument that assesses self-efficacy with eating disorder behaviors and attitudes. Total scores range from 1-5 with higher scores indicating greater self-efficacy. Changes in self-efficacy will be calculated using the baseline and 12-week scores from the EDRSQ.
Measured: Baseline and 12 weeks
Secondary outcomes (7)
Change in Parents Versus Anorexia Scale (PVA)
Changes in parent efficacy will be measured using the PVA which is a 7-item instrument that assesses parent's level of efficacy with helping their child with an eating disorder. Total scores range from 5-35 with higher scores indicating greater efficacy. Changes in efficacy will be calculated using the baseline and 12-week scores from the PVA.
Measured: Baseline and 12 weeks
Change in Depression Anxiety and Stress Scale (DASS)
Changes in patient stress will be measured using the DASS. The DASS is a 42-item self-report measure of negative emotional states with subscales of depression, anxiety, and stress symptoms. Each subscale is scored 0-42, with total scores ranging from 0-126. Higher scores indicate more severe psychological distress. Changes in stress will be calculated using the baseline and 12-week total score of the DASS.
Measured: Baseline and 12 weeks
Change in Center for Epidemiologic Studies-Depression (CES-D)
Changes in parental stress will be measured using the CES-D, which is a 20-item self-report measure evaluating depressive symptoms. Scores range from 0 to 60 with higher scores indicating greater impairment. Changes in stress will be calculated using the baseline and 12-week total score of the CES-D.
Measured: Baseline and 12 weeks
Change in the Clinical Impairment Assessment (CIA)
Patient impairment is measured using the Clinical Impairment Assessment, which is a 16-item self-report measure of impairment from eating disorders. Responses are scored using 0, 1, 2, or 3 and the score is calculated using the sum of all items. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment. Change in impairment will be calculated using the baseline and 12-week scores from CIA.
Measured: Baseline and 12 weeks
Change in weight
Weight will be measured in the EWDP IP clinic by study staff during all study visits. Change in weight will be calculated using the baseline and 12-week measurements.
Measured: Baseline and 12 weeks
Number of Contacts with Coach outside treatment visit
Coaching utilization will be measured by tracking the number of contacts to the coach outside of treatment visits. Utilization will be calculated using the sum of contacts throughout the 12-week treatment.
Measured: 12 weeks
Number of Treatment visits attended
Coaching utilization will be measured by tracking the number of treatment visits attended. Utilization will be calculated using the sum of treatment visits throughout the 12-week treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 May 2023
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Model description
- Participants will be randomized to one of two conditions in a parallel design including a 12-week intervention. Participants will be recruited from the Center of Excellence in Eating and Weight Disorders Program (EWDP) until the recruitment goal of 70, 35 in each group, is reached.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Hildebrandt, Icahn School of Medicine at Mount Sinai
- Investigators
- Tom Hildebrandt, PsyD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562258
- Sponsor's protocol ID
- STUDY-22-00748
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data can be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Peer-Coaching Model for the Treatment of Eating Disorders
- ClinicalTrials.gov ID
- NCT05562258
- Acronym / sponsor ID
- STUDY-22-00748
- Conditions
- Eating Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 30 Sep 2022 (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 project includes developing and testing a coaching approach during the treatment of eating disorders. It is expected that with the addition of support outside of regular treatment, caregivers will experience improvements in emotional taxation and patients will strengthen skills necessary for recovery. Twelve weeks of coaching will be incorporated into standard treatment. Randomization will occur placing participants into (1) parent coaching + patient educational materials or (2) parent educational materials + patient coaching.
Detailed description
A total of 70 adolescents with eating disorders between the ages of 12-18 and their parents/caregivers will be enrolled in a randomized-controlled trial comparing parent coaching/patient education to parent education/patient coaching. Measures will include demographics, vitals, parent and patient self-efficacy, quality of life, illness related distress/impairment, and changes in eating disorder symptoms and severity.
During a screening and consenting visit, participants will complete assessments including height, weight, demographics, and interview questions to determine inclusion/exclusion criteria and eating disorder diagnoses. At baseline, patients and parents will complete online questionnaires via a REDCap interface, measuring self-efficacy, quality of life, and illness related distress/impairment.
During the intervention, participants will attend standard therapy sessions for the treatment of eating disorders, and patients and parents will be randomized to either have access to a designated coach or weekly educational materials. Patients and parents assigned to coaching will be able to contact their coach outside of their therapy session time for 15-minute coaching calls. Completed calls will be tracked to document engagement with coaching. Patients and parents assigned to weekly education materials will receive a link, which will direct them to YouTube videos related to the skills covered in therapy for that week. They will also receive a link with a few questions to document engagement with each video.
- Coaching: A coach trained in specific skills targeted to assist in family-based therapy, will be assigned to the parent/patient to be available throughout the 12-week intervention. The coach will available between the hours of 9am - 9pm, Monday - Sunday for a brief 15-minute coaching call. During the call, the coach will remind the parent/patient of family-based skills that can be utilized in vivo to address emerging situations. If a call is running over 15 minutes, the coach will refer them to their primary therapist or emergency services.
- Educational Materials: A 2-5 minute YouTube video will be distributed to the parent/patient weekly. Videos will incorporate a new skill learned in therapy that week.
Follow-up measures will be conducted mid-way through treatment and at the end-of-treatment, and these visits will involve patients and parents repeating the assessments administered during baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two conditions in a parallel design including a 12-week intervention. Participants will be recruited from the Center of Excellence in Eating and Weight Disorders Program (EWDP) until the recruitment goal of 70, 35 in each group, is reached.
| Arm | Type | Receives |
|---|---|---|
| Parent Coaching and Patient Education | Experimental | Behavioral: Parent Coaching and Patient EducationThis group includes 12 weeks of eating disorder therapy provided to the patient. Outside of therapy, parents will have access to a coach and patients will have access to weekly educational material. |
| Parent Education and Patient Coaching | Experimental | Behavioral: Parent Education and Patient CoachingThis group includes 12 weeks of eating disorder therapy provided to the patient. Outside of therapy, parents will have access to weekly educational material and patients will have access to a coach. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Ages 12 to 18 at entry to the study
- DSM-5 Diagnosis of an eating disorder
- Enrollment in treatment at the Center of Excellence for Eating and Weight Disorders Speak English
- Have access to a phone with WiFi or a data plan
- Parent and child/patient both willing to participate
Key exclusion criteria (2 listed)
- Current or lifetime history of learning disorder or developmental disorder
- Acute suicide risk
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 |
|---|---|---|
| Parent Coaching and Patient EducationThis group includes 12 weeks of eating disorder therapy provided to the patient. Outside of therapy, parents will have access to a coach and patients will have access to weekly educational material. | Behavioural | Parent Coaching and Patient Education |
| Parent Education and Patient CoachingThis group includes 12 weeks of eating disorder therapy provided to the patient. Outside of therapy, parents will have access to weekly educational material and patients will have access to a coach. | Behavioural | Parent Education and Patient Coaching |
Primary outcome
Change in Eating Disorder Recovery Self-Efficacy Questionnaire (EDRSQ)
Time frame: Baseline and 12 weeks
Changes in patient self-efficacy will be measured using the EDRSQ, which is a 23-item instrument that assesses self-efficacy with eating disorder behaviors and attitudes. Total scores range from 1-5 with higher scores indicating greater self-efficacy. Changes in self-efficacy will be calculated using the baseline and 12-week scores from the EDRSQ.
7 secondary outcomes
Change in Parents Versus Anorexia Scale (PVA)
Time frame: Baseline and 12 weeks
Change in Depression Anxiety and Stress Scale (DASS)
Time frame: Baseline and 12 weeks
Change in Center for Epidemiologic Studies-Depression (CES-D)
Time frame: Baseline and 12 weeks
Change in the Clinical Impairment Assessment (CIA)
Time frame: Baseline and 12 weeks
Change in weight
Time frame: Baseline and 12 weeks
Number of Contacts with Coach outside treatment visit
Time frame: 12 weeks
Number of Treatment visits attended
Time frame: 12 weeks
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 8 Sep 2026.
- Individual participant dataSharing planned: No. Anonymized data can be made available upon request.
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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.
Tom Hildebrandt, PsyD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Coaching and Patient Education and Parent Education and Patient Coaching in people with Eating Disorder, run by Icahn School of Medicine at Mount Sinai 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Sep 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 Tom Hildebrandt, PsyD (212-659-8673, tom.hildebrandt@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Eating Disorder Recovery Self-Efficacy Questionnaire (EDRSQ) (time frame: Baseline and 12 weeks). 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 8 Sep 2026.