NCT00672906

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 16, 2014

Status Verified

May 1, 2014

Enrollment Period

7.4 years

First QC Date

May 4, 2008

Last Update Submit

September 12, 2014

Conditions

Keywords

anorexia nervosagroup parent trainingcaregiver burdeneating disorderstreatment

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    12 months

Secondary Outcomes (1)

  • Eating disorder symptoms other than body weight.

    12 months

Study Arms (2)

1

EXPERIMENTAL

Group Parent Training/Adolescent Skills Training

Behavioral: Group Parent Training

Active Comparator

ACTIVE COMPARATOR

Family Therapy according to the Maudsley Model

Behavioral: Maudsley Family Therapy

Interventions

Skills group for parents that provides psychoeducation for eating disorder and skills in behavior management, self-regulation, and emotion regulation.

1

Family therapy specifically adapted for the treatment of adolescent anorexia nervosa.

Active Comparator

Eligibility Criteria

Age11 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 11-18 years old
  • living at home
  • meet criteria for anorexia nervosa or subthreshold anorexia nervosa

You may not qualify if:

  • no active psychosis
  • no current suicidality
  • medically safe for outpatient treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Anorexia NervosaCaregiver BurdenFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersStress, PsychologicalBehavioral SymptomsBehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2008

First Posted

May 6, 2008

Study Start

July 1, 2005

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

September 16, 2014

Record last verified: 2014-05

Locations