NCT00149812

Brief Summary

This study will assess the effectiveness of the "Keeping Families Strong" program (KFS) in avoiding or delaying the onset of psychiatric disorders among children with depressed mothers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 depression

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1 depression

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

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

3.4 years

First QC Date

September 6, 2005

Last Update Submit

August 3, 2016

Conditions

Keywords

DepressionChild disruptive behaviorFamily functioning

Outcome Measures

Primary Outcomes (1)

  • Acceptability of program to parents, children, clinicians, and administrators throughout 10 weeks

    10 weeks

Secondary Outcomes (1)

  • Improvement in the understanding of depression, family communication, parenting practices, and child coping over a one-year period

    1 year

Study Arms (1)

Intervention

EXPERIMENTAL

Intervention: "Keeping Families Strong" Cognitive Behavioral and Communication intervention with mothers recovering from depression and their children, 9 years and older.

Behavioral: Family Functioning Intervention

Interventions

Intervention

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parent in treatment for depression
  • Parent in maintenance phase of treatment

You may not qualify if:

  • Active substance abuse
  • Substantial cognitive impairment
  • Psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

  • Riley AW, Valdez CR, Barrueco S, Mills C, Beardslee W, Sandler I, Rawal P. Development of a family-based program to reduce risk and promote resilience among families affected by maternal depression: theoretical basis and program description. Clin Child Fam Psychol Rev. 2008 Jun;11(1-2):12-29. doi: 10.1007/s10567-008-0030-3.

    PMID: 18360775BACKGROUND
  • Valdez CR, Mills CL, Barrueco S, Leis J, Riley AW. A Pilot Study of a Family-Focused Intervention for Children and Families Affected by Maternal Depression. J Fam Ther. 2011 Feb;33(1):3-19. doi: 10.1111/j.1467-6427.2010.00529.x.

    PMID: 23420650BACKGROUND

MeSH Terms

Conditions

DepressionAttention Deficit Disorder with HyperactivityConduct Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Anne W. Riley, PhD

    Bloomberg School of Public Health, Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

January 1, 2005

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

August 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations