Group Parent Training for Adolescent Eating Disorders (GPT-AN)
Primary Purpose
Adolescent Anorexia Nervosa, Subthreshold Anorexia Nervosa
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Parent Training
Maudsley Family Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Anorexia Nervosa focused on measuring anorexia nervosa, group parent training, caregiver burden, eating disorders, treatment
Eligibility Criteria
Inclusion Criteria:
- age 11-18 years old
- living at home
- meet criteria for anorexia nervosa or subthreshold anorexia nervosa
Exclusion Criteria:
- no active psychosis
- no current suicidality
- medically safe for outpatient treatment
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
Active Comparator
Arm Description
Group Parent Training/Adolescent Skills Training
Family Therapy according to the Maudsley Model
Outcomes
Primary Outcome Measures
Body Mass Index
Secondary Outcome Measures
Eating disorder symptoms other than body weight.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00672906
Brief Title
Group Parent Training for Adolescent Eating Disorders
Acronym
GPT-AN
Official Title
Group Parent Training for Adolescent Eating Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
While parents are considered essential for the effective treatment of adolescents with anorexia nervosa, the most effective manner to involve parents in treatment is unknown. Given reports of high caregiver burden among parents of this clinical group, finding treatments that minimize parent burden while improving the child's eating disorder symptoms is essential.
This investigation will examine the preliminary effectiveness of a parent skills group and adolescent skills group compared to family therapy for the treatment of adolescent anorexia nervosa. The target of this intervention is the improvement of eating disorder symptoms in the child and improving self-efficacy, emotion regulation, and perceived burden in the parent.
The effectiveness of this experimental treatment group (Group Parent Training for the parents/Adolescent Skills Training for the adolescent) will be compared to the Maudsley model of family therapy. The effectiveness of the group program will be examined by exploring changes within individuals over time as well as via comparisons across treatment conditions. Results from this investigation will be used to calculate treatment effect sizes in the design of a larger, fully powered, randomized clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Anorexia Nervosa, Subthreshold Anorexia Nervosa
Keywords
anorexia nervosa, group parent training, caregiver burden, eating disorders, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Group Parent Training/Adolescent Skills Training
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Family Therapy according to the Maudsley Model
Intervention Type
Behavioral
Intervention Name(s)
Group Parent Training
Intervention Description
Skills group for parents that provides psychoeducation for eating disorder and skills in behavior management, self-regulation, and emotion regulation.
Intervention Type
Behavioral
Intervention Name(s)
Maudsley Family Therapy
Intervention Description
Family therapy specifically adapted for the treatment of adolescent anorexia nervosa.
Primary Outcome Measure Information:
Title
Body Mass Index
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Eating disorder symptoms other than body weight.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 11-18 years old
living at home
meet criteria for anorexia nervosa or subthreshold anorexia nervosa
Exclusion Criteria:
no active psychosis
no current suicidality
medically safe for outpatient treatment
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
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Group Parent Training for Adolescent Eating Disorders
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