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Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05562258
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact Tom Hildebrandt, PsyD
Phone 212-659-8673
Email tom.hildebrandt@mssm.edu
Status Recruiting
Phase N/A
Start date May 1, 2023
Completion date October 2024

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