Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-05 @ 5:40 PM
Study NCT ID:
NCT01802294
Status:
COMPLETED
Last Update Posted:
2014-06-13
First Post:
2013-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sinovuyo Caring Families Project - Pilot Trial
Sponsor:
University of Cape Town
Organization:
Study Overview
Official Title:
Sinovuyo Caring Families Project - Pilot Randomised Controlled Trial of a Parenting Program to Reduce Child Behavior Problems in Xhosa Children Ages 3 to 8 in South Africa
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCFP
Brief Summary:
This pilot feasibility trial will evaluate the Sinovuyo Caring Families Program in a small-scale randomized controlled trial in Cape Town, South Africa (n=60 families). The pilot study will use a mixed-methods approach to intervention evaluation. Self-report and observed quantitative data for intervention and control groups will be collected at pre-test and post-test evaluation. Primary outcomes will include parent-reports and observations of child behavior problems. In addition, as an exploratory study, this phase will examine initial pre-post intervention effects for potential mediating factors of parenting behavior, parental stress, parental depression, and perceived social support. However, this phase will not test mediation effects due to small sample sizes. Quantitative assessments will also collect data on program fidelity, exposure/adherence, participant engagement, and satisfaction. Furthermore, qualitative focus groups with intervention participants and group leaders will examine issues of program feasibility, content, deliver, and satisfaction. Randomization will be done on an individual level and include a wait-list control group that will receive the intervention 3 months after the post-test evaluation. Results from the feasibility pilot study will be shared with intervention partners and advisory groups. If necessary, final program adjustments will be made prior to further testing. Results will also be disseminated to community forums, local organizations, government stakeholders, and via academic conferences.
Research hypotheses:
Hypothesis 1: Children in the intervention group will demonstrate reduced observed and parent-reported child behavior problems in comparison to the control group.
Hypothesis 2: Parents in the intervention group will demonstrate increased observed and self-reported positive parenting outcomes and decreased observed and self-reported harsh and inconsistent parenting outcomes in comparison to the control group.
Hypothesis 3: Parents in the intervention group will demonstrate decreased parental depression and parental stress outcomes and increased perceived social support outcomes in comparison to the control group.
Hypothesis 4: The Sinovuyo Caring Families Program will be implemented with an acceptable degree of program fidelity, exposure/adherence, and participant satisfaction.
Research hypotheses:
Hypothesis 1: Children in the intervention group will demonstrate reduced observed and parent-reported child behavior problems in comparison to the control group.
Hypothesis 2: Parents in the intervention group will demonstrate increased observed and self-reported positive parenting outcomes and decreased observed and self-reported harsh and inconsistent parenting outcomes in comparison to the control group.
Hypothesis 3: Parents in the intervention group will demonstrate decreased parental depression and parental stress outcomes and increased perceived social support outcomes in comparison to the control group.
Hypothesis 4: The Sinovuyo Caring Families Program will be implemented with an acceptable degree of program fidelity, exposure/adherence, and participant satisfaction.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: