- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04779801
Attachment-Based Family Therapy for Adolescents With Binge Eating (ABFT)
March 2, 2021 updated by: Drexel University
Attachment-Based Family Therapy for Adolescents With Transdiagnostic Binge Eating
The purpose of this study is to examine whether Attachment-Based Family Therapy (ABFT), a well-validated treatment for adolescents with depression and suicidality, is feasible and acceptable for adolescents with binge eating and their families.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
This study involves a phone screen and baseline assessment to determine eligibility.
Participants who are eligible for the study will receive 16 weeks of ABFT treatment.
The treatment primarily focuses on improving communication and relationships within the family, and will also address disordered eating behaviors (e.g., binge eating, laxative use, self-induced vomiting).
All participants enrolled in the study will receive the same treatment.
Participants will also complete research assessments throughout treatment, at the end of treatment, and 3-months after the end of treatment.
Research assessments include a battery of questionnaires and interviews.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Drexel University
-
Contact:
- Sophie R Abber, B.A.
- Phone Number: 215-553-7110
- Email: wellteen@drexel.edu
-
Principal Investigator:
- Stephanie M Manasse, Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 22 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Speak, write, and understand English
- Age 12-22 years old
- Have a diagnosis of DSM-5 AN, BN, BED, or OSFED
- Medically stable for outpatient treatment
- Must have a parent, guardian, or primary caregiver who is willing to participate in the study and treatment
Exclusion Criteria:
- Acute suicide risk
- No parent or guardian agreement to participate
- Are currently receiving psychological treatment for an eating disorder
- Are currently receiving weight loss treatment
- Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence)
- Diagnosis of intellectual disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ABFT
Adolescents and one or both parents will complete 16 weeks of Attachment-Based Family Therapy treatment.
|
16 weeks of Attachment-Based Family Therapy treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Five-Minute Speech Sample (FMSS)
Time Frame: Change in critical comments and emotional overinvolvement from baseline to treatment completion, at 16 weeks
|
The Five-Minute Speech Sample is a widely-used interview to assess critical comments and emotional overinvolvement in families.
|
Change in critical comments and emotional overinvolvement from baseline to treatment completion, at 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eating Disorder Examination (EDE)
Time Frame: Change in frequency of binge-eating and, if applicable, purging from baseline to treatment completion, at 16 weeks
|
The Eating Disorder Examination is a widely-used, semi-structured interview for the assessment of eating disorder symptoms.
|
Change in frequency of binge-eating and, if applicable, purging from baseline to treatment completion, at 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2020
Primary Completion (Anticipated)
December 10, 2021
Study Completion (Anticipated)
April 10, 2022
Study Registration Dates
First Submitted
February 25, 2021
First Submitted That Met QC Criteria
March 2, 2021
First Posted (Actual)
March 3, 2021
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 2, 2021
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004007768
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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