Development and Testing of a Peer-Coaching Model for the Treatment of Eating Disorders
Primary Purpose
Eating Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Coaching and Patient Education
Parent Education and Patient Coaching
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorder
Eligibility 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
Sites / Locations
- Department of Psychiatry, Eating and Weight Disorders ProgramRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Parent Coaching and Patient Education
Parent Education and Patient Coaching
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05562258
First Posted
September 28, 2022
Last Updated
August 16, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05562258
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parent Coaching and Patient Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Parent Education and Patient Coaching
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Parent Coaching and Patient Education
Intervention Description
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
Intervention Name(s)
Parent Education and Patient Coaching
Intervention Description
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 Measure Information:
Title
Change in Eating Disorder Recovery Self-Efficacy Questionnaire (EDRSQ)
Description
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.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in Parents Versus Anorexia Scale (PVA)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in Depression Anxiety and Stress Scale (DASS)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in Center for Epidemiologic Studies-Depression (CES-D)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in the Clinical Impairment Assessment (CIA)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in weight
Description
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.
Time Frame
Baseline and 12 weeks
Title
Number of Contacts with Coach outside treatment visit
Description
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.
Time Frame
12 weeks
Title
Number of Treatment visits attended
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Hildebrandt, PsyD
Phone
212-659-8673
Email
tom.hildebrandt@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Bibeau, MA
Phone
212-659-8724
Email
jessica.bibeau@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Hildebrandt, PsyD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Eating and Weight Disorders Program
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Bibeau, MA
Phone
212-659-8724
Email
jessica.bibeau@mssm.edu
First Name & Middle Initial & Last Name & Degree
Tom Hildebrandt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Anonymized data can be made available upon request.
Learn more about this trial
Development and Testing of a Peer-Coaching Model for the Treatment of Eating Disorders
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