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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04779801
Other study ID # 2004007768
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 10, 2020
Est. completion date April 10, 2022

Study information

Verified date December 2020
Source Drexel University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date April 10, 2022
Est. primary completion date December 10, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years to 22 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Attachment-Based Family Therapy
16 weeks of Attachment-Based Family Therapy treatment.

Locations

Country Name City State
United States Drexel University Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Five-Minute Speech Sample (FMSS) 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 Eating Disorder Examination (EDE) 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
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