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Attachment-Based Family Therapy for Adolescents With Binge Eating (ABFT)

Primary Purpose

Bulimia Nervosa, Binge-Eating Disorder, Other Specified Feeding or Eating Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attachment-Based Family Therapy
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa

Eligibility Criteria

12 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Drexel UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABFT

Arm Description

Adolescents and one or both parents will complete 16 weeks of Attachment-Based Family Therapy treatment.

Outcomes

Primary Outcome Measures

Five-Minute Speech Sample (FMSS)
The Five-Minute Speech Sample is a widely-used interview to assess critical comments and emotional overinvolvement in families.

Secondary Outcome Measures

Eating Disorder Examination (EDE)
The Eating Disorder Examination is a widely-used, semi-structured interview for the assessment of eating disorder symptoms.

Full Information

First Posted
February 25, 2021
Last Updated
March 2, 2021
Sponsor
Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT04779801
Brief Title
Attachment-Based Family Therapy for Adolescents With Binge Eating
Acronym
ABFT
Official Title
Attachment-Based Family Therapy for Adolescents With Transdiagnostic Binge Eating
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
December 10, 2021 (Anticipated)
Study Completion Date
April 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Binge-Eating Disorder, Other Specified Feeding or Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ABFT
Arm Type
Experimental
Arm Description
Adolescents and one or both parents will complete 16 weeks of Attachment-Based Family Therapy treatment.
Intervention Type
Behavioral
Intervention Name(s)
Attachment-Based Family Therapy
Intervention Description
16 weeks of Attachment-Based Family Therapy treatment.
Primary Outcome Measure Information:
Title
Five-Minute Speech Sample (FMSS)
Description
The Five-Minute Speech Sample is a widely-used interview to assess critical comments and emotional overinvolvement in families.
Time Frame
Change in critical comments and emotional overinvolvement from baseline to treatment completion, at 16 weeks
Secondary Outcome Measure Information:
Title
Eating Disorder Examination (EDE)
Description
The Eating Disorder Examination is a widely-used, semi-structured interview for the assessment of eating disorder symptoms.
Time Frame
Change in frequency of binge-eating and, if applicable, purging from baseline to treatment completion, at 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie R Abber, B.A.
Phone
215-553-7110
Email
wellteen@drexel.edu
First Name & Middle Initial & Last Name & Degree
Stephanie M Manasse, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Attachment-Based Family Therapy for Adolescents With Binge Eating

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