Sinovuyo Caring Families Project - Pilot Trial

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.

Conditions

• Child Behavior
• Parenting
• Child Abuse

Interventions

BEHAVIORAL

Parenting Program

Goal of the program is reduction in child behavior problems in high-risk South African families. Program will be delivered to caregivers responsible for the wellbeing of the child. Program activities will be delivered over 12 weekly group sessions with additional individualized in-home sessions. The groups (n = 15 participants per group) will meet weekly with community facilitators (n = 2 per group). Parenting skills will be developed during the sessions through role-plays, group-discussion, storytelling, and home practice activities. The program is manualized in isiXhosa.

Sponsors & Collaborators

• University of Oxford

  collaborator OTHER

• Bangor University

  collaborator OTHER

• Ilifa Labantwana

  collaborator UNKNOWN

• University of Cape Town

  lead OTHER

Principal Investigators

• Catherine Ward, PhD · University of Cape Town

• Lucie Cluver, DPhil · University of Oxford

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-02-28

Primary Completion

2013-08-31

Completion

2013-08-31

Countries

• South Africa

Study Locations