Clinical trial NCT05562258: Development and Testing of a Peer-Coaching Model for the Treatment of Eating Disorders
Official title: Development and Testing of a Peer-Coaching Model for the Treatment of Eating Disorders
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Eating Disorder
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Eating Disorder Recovery Self-Efficacy Questionnaire (EDRSQ)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Parents Versus Anorexia Scale (PVA)
timeFrame: Baseline and 12 weeks
measure: Change in Depression Anxiety and Stress Scale (DASS)
timeFrame: Baseline and 12 weeks
measure: Change in Center for Epidemiologic Studies-Depression (CES-D)
timeFrame: Baseline and 12 weeks
measure: Change in the Clinical Impairment Assessment (CIA)
timeFrame: Baseline and 12 weeks
measure: Change in weight
timeFrame: Baseline and 12 weeks
measure: Number of Contacts with Coach outside treatment visit
timeFrame: 12 weeks
measure: Number of Treatment visits attended
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Psychiatry, Eating and Weight Disorders Program
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Tom Hildebrandt, PsyD
role: PRINCIPAL_INVESTIGATOR
References: