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Family Networks Project: An Efficacy Study of Stepping Stones Triple P for Children Under Age Two

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Quality Improvement Center for Early Childhood
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01424943
First received: July 27, 2011
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of the project is to assess the initial efficacy of Stepping Stones Triple P-Positive Parenting Program with parents of children below age two with developmental disabilities to strengthen families and prevent child maltreatment.


Condition Intervention
Prevent Child Maltreatment
 Behavioral: Stepping Stones Triple P
Other: BabyNet Services As usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Family Networks Project: Supporting Family Confidence, Competence, and Community Connections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Change from baseline in parenting style at 5 months [ Time Frame: Baseline, 5 months ] [ Designated as safety issue: No ]
    Parenting Scale

  • Change from baseline in child behavior at 5 months [ Time Frame: Baseline, 5 months ] [ Designated as safety issue: No ]
    Child Behavior Checklist 1/5-5

  • Change from baseline in parenting self-confidence at 5 months [ Time Frame: Baseline, 5 months ] [ Designated as safety issue: No ]
    Toddler Care Questionnaire

  • Change from baseline in parent responsivity to child at 5 months [ Time Frame: Baseline, 5 months ] [ Designated as safety issue: No ]
    KIPS observational measure


Secondary Outcome Measures:
  • Change from baseline in parent symptoms of depression, anxiety, and stress at 5 months [ Time Frame: baseline, 5 months ] [ Designated as safety issue: No ]
    DASS-21


Estimated Enrollment: 50
Study Start Date: December 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stepping Stones Triple P
10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
 Behavioral: Stepping Stones Triple P
10-12 session manualized intervention delivered in client homes
BabyNet Services As usual
BabyNet services as usual based on IFSP
 Behavioral: Stepping Stones Triple P
10-12 session manualized intervention delivered in client homes
Other: BabyNet Services As usual
BabyNet services as usual based on IFSP

Detailed Description:

This study is an initial efficacy trial of SSTP for parents of children below age 2. The target population consists of 50 families of young children ages 11-23 months with developmental disabilities who are eligible to receive IDEA Part C services in one region of South Carolina. Families will be randomly assigned to one of two conditions (1) IDEA Part C services as usual or (2) IDEA Part C services plus SSTP. Project goals are to strengthen parent competence, enhance parent confidence, and strengthen child social, emotional and behavioral functioning. Ultimately, this should result in a reduced likelihood of child maltreatment

  Eligibility

Ages Eligible for Study:   11 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • child age between 11 and 23 months of age
  • child eligible for IDEA Part C Services
  • parent english speaking
  • parent willing to allow in-home services

Exclusion Criteria:

  • disability requiring extensive out of home treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424943

Locations
United States, South Carolina
Parenting and Family Research Center
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Quality Improvement Center for Early Childhood
Investigators
Principal Investigator: Cheri Shapiro, Ph.D. Research Associate Professor, Parenting and Family Research Center, University of South Carolina
  More Information

Additional Information:
Quality Improvement Center for Early Childhood  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01424943     History of Changes
Other Study ID Numbers: QIC-EC Coop Agreement 90CA1763
Study First Received: July 27, 2011
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Carolina:
prevention
evidence-based parenting intervention
children
 disabilities
IDEA Part C
Stepping Stones Triple P

ClinicalTrials.gov processed this record on May 19, 2013