NCT04779801

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

December 10, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2022

Completed
Last Updated

March 3, 2021

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

February 25, 2021

Last Update Submit

March 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Eating Disorder Examination (EDE)

    Change in frequency of binge-eating and, if applicable, purging from baseline to treatment completion, at 16 weeks

Study Arms (1)

ABFT

EXPERIMENTAL

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

Behavioral: Attachment-Based Family Therapy

Interventions

16 weeks of Attachment-Based Family Therapy treatment.

ABFT

Eligibility Criteria

Age12 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Bulimia NervosaBinge-Eating DisorderFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 3, 2021

Study Start

December 10, 2020

Primary Completion

December 10, 2021

Study Completion

April 10, 2022

Last Updated

March 3, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations