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

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ClinicalTrials.gov Identifier: NCT01424943
Recruitment Status : Completed
First Posted : August 29, 2011
Results First Posted : December 15, 2014
Last Update Posted : December 15, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Family Networks Project Study One: Supporting Family Confidence, Competence, and Community Connections
Study Start Date : December 2010
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01424943     History of Changes
Other Study ID Numbers: QIC-EC Coop Agreement 90CA1763
First Posted: August 29, 2011    Key Record Dates
Results First Posted: December 15, 2014
Last Update Posted: December 15, 2014
Last Verified: October 2014

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