Community Implementation of KEEP: Fidelity and Generaliza... | NCT00980512

Studies
Community Implementation of KEEP: Fidelity and Generalization of Parenting

NCT00980512

Sponsor

San Diego State University

Status

Completed

Last Update Posted

Nov 18, 2014Estimated

Enrollment

354Actual

Phase

Not Applicable

Conditions

Behavior Problems

Interventions

Parent Training

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	Link
R01MH060195	U.S. NIH Grant/Contract	View source
2R01MH060195-06A1	U.S. NIH Grant/Contract	View source
DSIR 84-CTP

Status Module

Record Verification Date

Nov 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

Sep 2009

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Sep 18, 2009

First Submission Date that Met QC Criteria

Sep 18, 2009

First Posted Date

Sep 21, 2009Estimated

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

Nov 17, 2014

Last Update Posted Date

Nov 18, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Joseph M. Price, PI, San Diego State UniversityPrincipal Investigator

Lead Sponsor

San Diego State UniversityOTHER

Collaborators

Name	Class
National Institute of Mental Health (NIMH)	NIH
Oregon Social Learning Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The primary goal of this study is to examine the fidelity and generalization of parenting effects of the KEEP foster parent training intervention as it is being delivered within a child welfare system of care by a community mental health provider.

Detailed Description

The primary goal of this study is to utilize this opportunity as a real-world platform for addressing three key questions that need to be answered prior to wide-scale implementation of the KEEP intervention. First, do the effects of the KEEP parent training generalize (concurrently) to other children currently in foster and kin intervention homes and lead to reductions in overall levels of behavior problems? Second, does the KEEP intervention continue to have effects after the completion of the intervention and generalize (temporally) to new children who enter the homes of these families at a later point in time? Finally, as the KEEP intervention is being implemented by a community agency in a real-world system of care, can the intervention be delivered and maintained in a manner that preserves the goals and quality of the intervention?

Children in foster care, between the ages of 5 and 12, will be randomly assigned to one of two conditions - the KEEP intervention or a "services as usual" condition. In the KEEP intervention condition, foster and kin caregivers will participate in 16 weekly group meetings. Outcomes to be assessed include child problem behavior (of the focal child and other children in the household), child functioning, parental stress, family functioning, use of mental health services, child placement changes (e.g., reunification with biological parents, move to another foster home), and foster parent retention rates. In addition, for a year following the completion of the intervention, new children entering the home of foster/kin caregiver will be included in the assessments, along with the impact of these additional children on parental stress and family functioning. Finally, several dimensions of intervention fidelity (e.g., facilitator adherence and group engagement) will be assessed and examined in relation to child, family, and system outcomes.

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

354Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parent Training	Experimental	Parent Training of foster parents	Behavioral: Parent Training
Control	No Intervention	Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Parent Training	Behavioral	16 weeks of parent training led by trained group facilitator	Parent Training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in child behavior problems as assessed by the Parent Daily Report (PDR)		Baseline, 6-months, 12-months, 18-months

Secondary Outcomes

Measure	Description	Time Frame
Placement Disruptions from Foster Placement		6-month, 12-month, 18-month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any child between ages 5 and 12 in relative or non-relative foster care

Exclusion Criteria:

Only medically fragile children

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph M. Price, Ph.D.	San Diego State University & Child and Adolescent Services Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Child and Adolescent Services Research Center		San Diego	California	92123	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18185995	Background	Chamberlain P, Price J, Leve LD, Laurent H, Landsverk JA, Reid JB. Prevention of behavior problems for children in foster care: outcomes and mediation effects. Prev Sci. 2008 Mar;9(1):17-27. doi: 10.1007/s11121-007-0080-7. Epub 2008 Jan 10.
18174349	Background	Price JM, Chamberlain P, Landsverk J, Reid JB, Leve LD, Laurent H. Effects of a foster parent training intervention on placement changes of children in foster care. Child Maltreat. 2008 Feb;13(1):64-75. doi: 10.1177/1077559507310612.