Development and Testing of a Peer-Coaching Model for the Treatment of Eating Disorders

NCT ID: NCT05562258

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-10-31

Brief 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. 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.

Conditions

Eating Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parent Coaching and Patient Education

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.

Group Type: EXPERIMENTAL

Parent Coaching and Patient Education

Intervention Type: BEHAVIORAL

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 Coaching

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.

Group Type: EXPERIMENTAL

Parent Education and Patient Coaching

Intervention Type: BEHAVIORAL

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.

Interventions

Parent Coaching and Patient Education

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.

Intervention Type: BEHAVIORAL

Parent Education and Patient Coaching

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Current or lifetime history of learning disorder or developmental disorder
• Acute suicide risk

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Tom Hildebrandt

Professor of Psychiatry and Chief of the Division of Eating & Weight Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tom Hildebrandt, PsyD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tom Hildebrandt, PsyD

Role: CONTACT

tom.hildebrandt@mssm.edu

212-659-8673

Jessica Bibeau, MA

Role: CONTACT

jessica.bibeau@mssm.edu

212-659-8724

Facility Contacts

Jessica Bibeau, MA

Role: primary

jessica.bibeau@mssm.edu

212-659-8724

Other Identifiers

STUDY-22-00748

Identifier Type: -

Identifier Source: org_study_id