Sinovuyo Caring Families Project - Pilot Trial

NCT ID: NCT01802294

Last Updated: 2014-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-08-31

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.

Conditions

Child Behavior; Parenting; Child Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Parenting Program

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

Group Type: EXPERIMENTAL

Parenting Program

Intervention Type: BEHAVIORAL

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.

Wait-list control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Sinovuyo Caring Families Programme

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: collaborator

Bangor University

OTHER

Sponsor Role: collaborator

Ilifa Labantwana

UNKNOWN

Sponsor Role: collaborator

University of Cape Town

OTHER

Sponsor Role: lead

Responsible Party

Dr Catherine L. Ward

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine Ward, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Lucie Cluver, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Ikamva Labantu Wellness Centre

Cape Town, Western Cape, South Africa

Countries

South Africa

Other Identifiers

Griffin39

Identifier Type: -

Identifier Source: org_study_id