Group Parent Training for Adolescent Eating Disorders

Subthreshold Anorexia Nervosa Clinical Trial

— GPT-AN  

Official title:

Group Parent Training for Adolescent Eating Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672906
• Other study ID #: Pro00010889
• Secondary ID: 5K23MH070418-037
• Status: Completed
• Phase: N/A
• First received: May 4, 2008
• Last updated: September 12, 2014
• Start date: July 2005
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adolescent Anorexia Nervosa
• Anorexia
• Anorexia Nervosa
• Eating Disorders
• Subthreshold Anorexia Nervosa

Intervention

Behavioral:
• Group Parent Training
Skills group for parents that provides psychoeducation for eating disorder and skills in behavior management, self-regulation, and emotion regulation.
• Maudsley Family Therapy
Family therapy specifically adapted for the treatment of adolescent anorexia nervosa.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index		12 months	Yes
Secondary	Eating disorder symptoms other than body weight.		12 months	No