Prevent Child MaltreatmentNCT01424943
Family Networks Project Study One: An Efficacy Study of Stepping Stones Triple P for Children Under Age Two
A study testing Stepping Stones Triple P and BabyNet Services As usual in people with Prevent Child Maltreatment, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 23 months
- Conditions the study is for
- Prevent Child Maltreatment
- What is being tested?
- Stepping Stones Triple P and BabyNet Services As usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- disability requiring extensive out of home treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Parenting and Family Research Center
Columbia, South Carolina, 29208
About this study
Official title: 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.
Read the 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
- Conditions
- Prevent Child Maltreatment
- Being tested
- Stepping Stones Triple P, BabyNet Services As usual
- Keywords
- prevention, evidence-based parenting intervention, children, disabilities, IDEA Part C, Stepping Stones Triple P
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepping Stones Triple PBehavioural
10-12 session manualized intervention delivered in client homes
BabyNet Services As usualOther
BabyNet services as usual based on IFSP
| Study group | Role | What they receive |
|---|---|---|
| Stepping Stones Triple P | Experimental | 10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes Receives: Behavioral: Stepping Stones Triple P |
| BabyNet Services As usual | Other | BabyNet services as usual based on IFSP Receives: Behavioral: Stepping Stones Triple P; Other: BabyNet Services As usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Style
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.
Measured: Baseline, 5 months
Child Behavior
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.
Measured: Baseline, 5 months
Parenting Self-confidence
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.
Measured: Baseline, 5 months
KIPS
KIPS observational measure of the quality of the parent-child relationship. scores range from 1-5. Higher scores indicate a higher quality of relationship.
Measured: Baseline, 5 months
Secondary outcomes (1)
Parent Symptoms of Depression, Anxiety and Stress
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.
Measured: baseline, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prevent Child MaltreatmentStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Quality Improvement Center for Early Childhood
- Responsible party
- Principal investigator, Cheri Shapiro, Ph.D., University of South Carolina
- Investigators
- Cheri Shapiro, Ph.D., Principal investigator, Research Associate Professor, Parenting and Family Research Center, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424943
- Sponsor's protocol ID
- Pro00006462
- Status last verified
- Apr 2019
- First submitted
- 27 Jul 2011
- Last updated
- 18 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Family Networks Project Study One: Supporting Family Confidence, Competence, and Community Connections
- ClinicalTrials.gov ID
- NCT01424943
- Acronym / sponsor ID
- Pro00006462
- Conditions
- Prevent Child Maltreatment
- Keywords
- prevention, evidence-based parenting intervention, children, disabilities, IDEA Part C, Stepping Stones Triple P
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Quality Improvement Center for Early Childhood
- Study start
- Dec 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Posted 15 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepping Stones Triple P | Experimental | Behavioral: Stepping Stones Triple P10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes |
| BabyNet Services As usual | Other | Behavioral: Stepping Stones Triple P, Other: BabyNet Services As usualBabyNet services as usual based on IFSP |
Who may qualify
- Ages
- 11 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- disability requiring extensive out of home treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepping Stones Triple P10-12 session manualized intervention delivered in client homes | Behavioural | BabyNet Services As usual, Stepping Stones Triple P |
| BabyNet Services As usualBabyNet services as usual based on IFSP | Other | BabyNet Services As usual |
Primary outcome
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.
1 secondary outcome
Parent Symptoms of Depression, Anxiety and Stress
Time frame: baseline, 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheri Shapiro, Ph.D. principal investigator
Research Associate Professor, Parenting and Family Research Center, University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepping Stones Triple P and BabyNet Services As usual in people with Prevent Child Maltreatment, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Style (time frame: Baseline, 5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.