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Trial record 1 of 24 for:    Developmental Disabilities | ( Map: South Carolina, United States )
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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 : April 18, 2019
Sponsor:
Collaborator:
Quality Improvement Center for Early Childhood
Information provided by (Responsible Party):
Cheri Shapiro, Ph.D., University of South Carolina

Tracking Information
First Submitted Date  ICMJE July 27, 2011
First Posted Date  ICMJE August 29, 2011
Results First Submitted Date  ICMJE July 22, 2014
Results First Posted Date  ICMJE December 15, 2014
Last Update Posted Date April 18, 2019
Study Start Date  ICMJE December 2010
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2011)
  • Change from baseline in parenting style at 5 months [ Time Frame: Baseline, 5 months ]
    Parenting Scale
  • Change from baseline in child behavior at 5 months [ Time Frame: Baseline, 5 months ]
    Child Behavior Checklist 1/5-5
  • Change from baseline in parenting self-confidence at 5 months [ Time Frame: Baseline, 5 months ]
    Toddler Care Questionnaire
  • Change from baseline in parent responsivity to child at 5 months [ Time Frame: Baseline, 5 months ]
    KIPS observational measure
Change History Complete list of historical versions of study NCT01424943 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2011)
Change from baseline in parent symptoms of depression, anxiety, and stress at 5 months [ Time Frame: baseline, 5 months ]
DASS-21
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Family Networks Project Study One: An Efficacy Study of Stepping Stones Triple P for Children Under Age Two
Official Title  ICMJE The Family Networks Project Study One: Supporting Family Confidence, Competence, and Community Connections
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prevent Child Maltreatment
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Stepping Stones Triple P
    10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
    Intervention: Behavioral: Stepping Stones Triple P
  • BabyNet Services As usual
    BabyNet services as usual based on IFSP
    Interventions:
    • Behavioral: Stepping Stones Triple P
    • Other: BabyNet Services As usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2014)
49
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2011)
50
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Months to 23 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01424943
Other Study ID Numbers  ICMJE Pro00006462
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cheri Shapiro, Ph.D., University of South Carolina
Study Sponsor  ICMJE University of South Carolina
Collaborators  ICMJE Quality Improvement Center for Early Childhood
Investigators  ICMJE
Principal Investigator: Cheri Shapiro, Ph.D. Research Associate Professor, Parenting and Family Research Center, University of South Carolina
PRS Account University of South Carolina
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP