Group Parent Training for Adolescent Eating Disorders | NCT00672906

Studies
Group Parent Training for Adolescent Eating Disorders

NCT00672906

Sponsor

Duke University

Status

Completed

Last Update Posted

Sep 16, 2014Estimated

Enrollment

124Actual

Phase

Not Applicable

Conditions

Adolescent Anorexia Nervosa
Subthreshold Anorexia Nervosa

Interventions

Group Parent Training
Maudsley Family Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5K23MH070418-03	U.S. NIH Grant/Contract		View source
7767	Other Identifier	Duke legacy protocol ID

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

May 4, 2008

First Submission Date that Met QC Criteria

May 4, 2008

First Posted Date

May 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2014

Last Update Posted Date

Sep 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Group Parent Training	Behavioral	Skills group for parents that provides psychoeducation for eating disorder and skills in behavior management, self-regulation, and emotion regulation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body Mass Index		12 months

Secondary Outcomes

Measure	Description	Time Frame
Eating disorder symptoms other than body weight.		12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27710	United States

Condition Browse Module

MeSH Terms

ID	Term
D000856	Anorexia Nervosa
D000084802	Caregiver Burden
D001068	Feeding and Eating Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders
D013315	Stress, Psychological
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided