- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01424943
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
Status
Completed
Conditions
Intervention / Treatment
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
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Columbia, South Carolina, United States, 29208
- Parenting and Family Research Center
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-
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.
Sponsor
Collaborators
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.
Helpful Links
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
Keywords
Other Study ID Numbers
- Pro00006462
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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