Clinical trial NCT01802294: Sinovuyo Caring Families Project - Pilot Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Child Behavior
Parenting
Child Abuse
Keywords: Randomized Controlled Trials as Topic
Child
Parents
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: Bangor University
name: Ilifa Labantwana
First posted: 2013-03-01
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Eyberg Child Behavior Inventory
timeFrame: Change from baseline to 1 week post-program (13 weeks from baseline)
measure: Family Observation Scale, 6th Edition
timeFrame: Change from baseline to 1 week post-program (13 weeks from baseline)
Secondary outcomes:
measure: Parent-Child Conflict Tactics Scale (CTSPC) (Straus et al., 1998)
timeFrame: Change from baseline to 1 week post-program (13 weeks from baseline)
measure: Parenting Young Children Scale (PARYC)
timeFrame: Change from baseline to 1 week post-program (13 weeks from baseline)
measure: Parenting Stress Index-Short Form, Distress Subscale
timeFrame: Change from baseline to 1 week post-program (13 weeks from baseline)
measure: Beck Depression Inventory (BDI-II)
timeFrame: Change from baseline to 1 week post-program (13 weeks from baseline)
measure: Multidimensional Scale of Perceived Social Support (MSPSS, 12-items)
timeFrame: Change from baseline to 1 week post-program (13 weeks from baseline)
measure: Parental Monitoring
timeFrame: Change from baseline to 1 week post-program (13 weeks from baseline)
measure: Empathy and Personality traits of child
timeFrame: Baseline
measure: Theory of mind
timeFrame: Baseline
measure: Cognitive status
timeFrame: Baseline
Other outcomes:
measure: Implementation Fidelity
timeFrame: Measured weekly over the 12 weeks of the program
measure: Program exposure, adherence, and engagement
timeFrame: Measured weekly over the 12 weeks of the program
measure: Participant Satisfaction
timeFrame: Measured weekly over the 12 weeks of the program
measure: Program feasibility
timeFrame: Measured immediately after the program is over (13 weeks from baseline)
measure: Revised Conflict Tactics Short Form
timeFrame: Change from baseline to 1 week post-program (13 weeks from baseline)
measure: World Health Organization Alcohol, Smoking and Substance Screening Tool (ASSIST)
timeFrame: Change from baseline to 1 week post-program (13 weeks from baseline)
measure: Government grants
timeFrame: Change from baseline to 1 week post-program (13 weeks from baseline)
measure: Parent Physical Illness
timeFrame: Change from baseline to 1 week post-program (13 weeks from baseline)
measure: AIDS-related child orphanhood and parental HIV-status and/or AIDS-sickness
timeFrame: Change from baseline to 1 week post-program (13 weeks from baseline)
Locations:
city: Cape Town
country: South Africa
facility: Ikamva Labantu Wellness Centre
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Catherine Ward, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Lucie Cluver, DPhil
role: PRINCIPAL_INVESTIGATOR
References: