Sinovuyo Caring Families Project - Pilot Trial (SCFP)

University of Cape Town (UCT)

Status and phase: Completed; Phase 1

Conditions: Parenting; Child Behavior; Child Abuse

Treatments: Behavioral: Parenting Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01802294

Griffin39

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• isiXhosa-speaking adults above the age of 18
• primary guardians of children aged 3-8 from Khayelitsha, Cape Town
• reside in the same household as child for at least 4 nights per week
• Score 11 or more on Eyberg Child Behavior Inventory Problem Scale

Exclusion criteria

• Severe mental health problems on Beck Depression Inventory
• Evidence of severe child maltreatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Parenting Program

Experimental group

Description:

12-week group-based parenting program (Sinovuyo Caring Family Programme) delivered in weekly sessions. Program is manualized.

Treatment:

Behavioral: Parenting Program

Wait-list control

No Intervention group

Description:

Wait-list control group. Program delivered 3 months after posttest.