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
About this trial
This is an interventional treatment trial for Bulimia Nervosa
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
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
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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