NCT00604097

Brief Summary

The purpose of the study is to test the efficacy of a brief family therapy (Attachment-Based Family Therapy) for youth presenting in primary care with suicidal ideation and depressed mood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2004

Typical duration for phase_3

Geographic Reach
1 country

4 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

September 1, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

2.7 years

First QC Date

January 16, 2008

Last Update Submit

December 13, 2012

Conditions

Keywords

youth suicidefamily therapyprimary careintervention

Outcome Measures

Primary Outcomes (3)

  • Suicidal Ideation Questionnaire - JR (SIQ-JR)

    Baseline, 6 weeks, 12 weels, 24 weeks

  • Beck Depression Inventory - II (BDI-II)

    Baseline, 6 weeks, 12 weeks, 24 weeks

  • Scale for Suicidal Ideation (SSI)

    baseline, 6 weeks, 12 weeks, 24 weeks

Secondary Outcomes (1)

  • Treatment retention

    12 weeks

Study Arms (2)

1

EXPERIMENTAL

Attachment-Based Family Therapy

Behavioral: Attachment-Based Family Therapy

2

ACTIVE COMPARATOR

Enhanced Usual Care

Behavioral: Enhanced Usual Care

Interventions

12-16 week family-based therapy

1

Rapid referral to community outpatient care with weekly monitoring of symptoms by study team

2

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Suicidal ideation (SIQ-JR \> 30)
  • Moderate depressed mood (BDI-II \> 19)
  • At least one parent/caregiver willing to participate

You may not qualify if:

  • Psychosis
  • Mental retardation or other significant cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHOP Adolescent Care Center

Philadelphia, Pennsylvania, 19104, United States

Location

CHOP University City Primary Care

Philadelphia, Pennsylvania, 19104, United States

Location

CHOP Primary Care Center at Cobb's Creek

Philadelphia, Pennsylvania, 19139-3723, United States

Location

CHOP Primary Care Center in South Philadelphia

Philadelphia, Pennsylvania, 19145, United States

Location

Related Publications (2)

  • Diamond G, Creed T, Gillham J, Gallop R, Hamilton JL. Sexual trauma history does not moderate treatment outcome in Attachment-Based Family Therapy (ABFT) for adolescents with suicide ideation. J Fam Psychol. 2012 Aug;26(4):595-605. doi: 10.1037/a0028414. Epub 2012 Jun 18.

  • Diamond GS, Wintersteen MB, Brown GK, Diamond GM, Gallop R, Shelef K, Levy S. Attachment-based family therapy for adolescents with suicidal ideation: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2010 Feb;49(2):122-31. doi: 10.1097/00004583-201002000-00006.

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Guy S Diamond, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 29, 2008

Study Start

September 1, 2004

Primary Completion

May 1, 2007

Study Completion

August 1, 2008

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations