NCT00610753

Brief Summary

This study will compare the effectiveness of two different family treatments for the treatment of adolescent anorexia nervosa.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_3

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

6 years

First QC Date

January 25, 2008

Last Update Submit

February 7, 2013

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosaAdolescentsFamily therapy

Outcome Measures

Primary Outcomes (1)

  • Percent Ideal Body Weight (%IBW)

    Patients weighed in gowns on calibrated balance beam machines and height assessed with a stadiometer. Percent Ideal Body Weight calculated on a study designed calculator.

    9-months and 21-months

Secondary Outcomes (1)

  • Eating Disorder Psychopathology

    9 months and 21 months

Study Arms (2)

Family Behavioral Therapy

EXPERIMENTAL

This intervention focuses on counseling the parents (and other family members) on refeeding their child. When weight is being steadily regained the focus of therapy shifts to allow the child more independence.

Behavioral: Family Behavior Therapy

Systems Family Therapy

ACTIVE COMPARATOR

This therapy focuses primarily on clarifying psychological processes within the family.

Behavioral: Systems Family Therapy

Interventions

Family Behavior TherapyBEHAVIORAL

This treatment is usually delivered in two phases: In the first phase there is an initial investigation of family behavior around feeding using a family meal followed by family therapy focused on enhancing feeding of the anorexic child in order to promote weight gain. In the second phase, once weight gain is well established the adolescent is given greater autonomy over feeding and in later sessions over other issues.

Also known as: Maudsley Family Therapy
Family Behavioral Therapy
Systems Family TherapyBEHAVIORAL

This therapy is applied in three phases. 1. In the first 2 or 3-sessions the treatment is explained to the family and an initial examination of family issues begins. 2. In the second phase family interactions and psychological processes are explored with clarification for family members. 3. In the third phase knowledge of family patterns is refined aiming for behavior change.

Also known as: Family Therapy
Systems Family Therapy

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

UCSD Center for Eating Disorder Treatment & Research

San Diego, California, 92037, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Sheppard-Pratt Health System

Baltimore, Maryland, 21204, United States

Location

Washington University, Department of Psychiatry

St Louis, Missouri, 63110, United States

Location

Department of Psychiatry, Cornell University

White Plains, New York, 10605, United States

Location

Laureate Psychiatric Clinic & Hospital

Tulsa, Oklahoma, 74136, United States

Location

Toronto General Hospital

Toronto, Ontario, M5G 2, Canada

Location

Related Publications (3)

  • Lock J, Brandt H, Woodside B, Agras S, Halmi WK, Johnson C, Kaye W, Wilfley D. Challenges in conducting a multi-site randomized clinical trial comparing treatments for adolescent anorexia nervosa. Int J Eat Disord. 2012 Mar;45(2):202-13. doi: 10.1002/eat.20923. Epub 2011 Apr 14.

    PMID: 21495052BACKGROUND

  • Sadeh-Sharvit S, Arnow KD, Osipov L, Lock JD, Jo B, Pajarito S, Brandt H, Dodge E, Halmi KA, Johnson C, Kaye W, Wilfley D, Agras WS. Are parental self-efficacy and family flexibility mediators of treatment for anorexia nervosa? Int J Eat Disord. 2018 Mar;51(3):275-280. doi: 10.1002/eat.22826. Epub 2018 Jan 4.

    PMID: 29314160DERIVED

  • Agras WS, Lock J, Brandt H, Bryson SW, Dodge E, Halmi KA, Jo B, Johnson C, Kaye W, Wilfley D, Woodside B. Comparison of 2 family therapies for adolescent anorexia nervosa: a randomized parallel trial. JAMA Psychiatry. 2014 Nov;71(11):1279-86. doi: 10.1001/jamapsychiatry.2014.1025.

    PMID: 25250660DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Family Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • William Stewart Agras

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus

Study Record Dates

First Submitted

January 25, 2008

First Posted

February 8, 2008

Study Start

July 1, 2006

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 11, 2013

Record last verified: 2013-02

Locations

CA(1)US(6)