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Trial record 20 of 48 for:    Open Studies | "Anorexia"
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Group Parent Training for Adolescent Eating Disorders (GPT-AN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Duke University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00672906
First received: May 4, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Adolescent Anorexia Nervosa
Subthreshold Anorexia Nervosa
 Behavioral: Group Parent Training
Behavioral: Maudsley Family Therapy
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group Parent Training for Adolescent Eating Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Body Mass Index [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Eating disorder symptoms other than body weight. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2005
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Group Parent Training/Adolescent Skills Training
 Behavioral: Group Parent Training
Skills group for parents that provides psychoeducation for eating disorder and skills in behavior management, self-regulation, and emotion regulation.
Active Comparator: Active Comparator
Family Therapy according to the Maudsley Model
 Behavioral: Maudsley Family Therapy
Family therapy specifically adapted for the treatment of adolescent anorexia nervosa.

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672906

Contacts
Contact: Nancy L. Zucker, Ph.D. 919-668-2281 zucke001@mc.duke.edu
Contact: JoAnn Rubin, M.S. 919-684-5712 rubin010@mc.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
  More Information

No publications provided

Responsible Party: Nancy Zucker, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00672906     History of Changes
Other Study ID Numbers: 7767, 5-K23-MH-070418-03
Study First Received: May 4, 2008
Last Updated: May 4, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
anorexia nervosa
group parent training
caregiver burden
eating disorders
treatment

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Eating Disorders
 Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013