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Recruiting NCT05562258

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

No phase Interventional Eating Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Parent Coaching and Patient Education, Parent Education and Patient Coaching.
Who it may be relevant to
Registry conditions: Eating Disorder. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 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.
  • 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.

Primary outcome measures

  • Change in Eating Disorder Recovery Self-Efficacy Questionnaire (EDRSQ) [Time frame: Baseline and 12 weeks]
Secondary outcome measures (7)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Department of Psychiatry, Eating and Weight Disorders Program — New York

Identifiers

NCT: NCT05562258 · STUDY-22-00748

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗