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

April 16, 2019 updated by: Cheri Shapiro, Ph.D., University of South Carolina

The Family Networks Project Study One: Supporting Family Confidence, Competence, and Community Connections

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

Study Overview

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 (Individuals with Disabilities Education Act 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

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • Parenting and Family Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stepping Stones Triple P
10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
10-12 session manualized intervention delivered in client homes
Other: BabyNet Services As usual
BabyNet services as usual based on IFSP
10-12 session manualized intervention delivered in client homes
BabyNet services as usual based on IFSP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parenting Style
Time Frame: Baseline, 5 months
Parenting Scale (Total Score; measure of parenting style). 30 items on the scale, scores range from 1-7 for each item with higher scores indicating dysfunctional parenting styles (laxness, over-reactivity, hostility). Scores summed and divided by 30 for total score.
Baseline, 5 months
Child Behavior
Time Frame: Baseline, 5 months
Child Behavior Checklist 1/5-5. A parent report measure of child behavioral problems. The score used for this outcome was the CBCL Total Score, which is a T-Score. T scores average 50 with a standard deviation of 10. Scores above 65 considered in the clinical range.
Baseline, 5 months
Parenting Self-confidence
Time Frame: Baseline, 5 months
Toddler Care Questionnaire. Measures parent reported self-confidence in parenting a toddler. Parents rate their confidence in performing parenting tasks specific to toddlers. Higher scores indicate more confidence. Scores range from 37-185. The total sum score derived from adding the scores for the 37 items in this survey was used for this outcome measure.
Baseline, 5 months
KIPS
Time Frame: Baseline, 5 months
KIPS observational measure of the quality of the parent-child relationship. scores range from 1-5. Higher scores indicate a higher quality of relationship.
Baseline, 5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent Symptoms of Depression, Anxiety and Stress
Time Frame: baseline, 5 months
DASS-21, brief screening measure of symptoms of depression, anxiety, and stress. Scores on each scale range from 0-21. Higher scores indicate more symptoms in each area.
baseline, 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cheri Shapiro, Ph.D., Research Associate Professor, Parenting and Family Research Center, University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 27, 2011

First Submitted That Met QC Criteria

August 26, 2011

First Posted (Estimate)

August 29, 2011

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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