NCT05562258

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
May 2023Oct 2026

First Submitted

Initial submission to the registry

September 28, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

3.4 years

First QC Date

September 28, 2022

Last Update Submit

October 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 12 weeks

Secondary Outcomes (7)

  • Change in Parents Versus Anorexia Scale (PVA)

    Baseline and 12 weeks

  • Change in Depression Anxiety and Stress Scale (DASS)

    Baseline and 12 weeks

  • Change in Center for Epidemiologic Studies-Depression (CES-D)

    Baseline and 12 weeks

  • Change in the Clinical Impairment Assessment (CIA)

    Baseline and 12 weeks

  • Change in weight

    Baseline and 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Parent Coaching and Patient Education

EXPERIMENTAL

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 Coaching and Patient Education

Parent Education and Patient Coaching

EXPERIMENTAL

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.

Behavioral: Parent Education and Patient Coaching

Interventions

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 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 weekly educational material and patients will have access to a coach.

Parent Education and Patient Coaching

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Tom Hildebrandt, PsyD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Hildebrandt, PsyD

CONTACT

Jessica Bibeau, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Chief of the Division of Eating & Weight Disorders

Study Record Dates

First Submitted

September 28, 2022

First Posted

September 30, 2022

Study Start

May 1, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

October 7, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Anonymized data can be made available upon request.

Locations