Sinovuyo Caring Families Project - Pilot Trial

NCT01802294 | Completed Phase 1

• 1 other identifier: Griffin39
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Keywords

Randomized Controlled Trials as Topic; Child; Parents

Outcome Measures

Primary Outcomes (2)

• Eyberg Child Behavior Inventory

  This 36-item examines externalizing behavior problems in children ages 2 to 16 using both an Intensity Scale and Problem Scale. Parents are asked how often a specific behavior occurs and whether the behavior is considered a problem. Based on the most typical child behavior problems, items include "has poor table manners," "acts defiant when told to do something," "physically fights with sisters and brothers," and "fails to finish tasks or project." The Intensity Scale rates frequency of occurrence based on a 7-point Likert scale (1 = never occurs to 7 = always occurs). The Problem Scale measures whether the parent identifies a specific behavior as a problem (0 = no; 1 = yes). Both scales are summed up to create a total Intensity Score and Problem Score. Clinical cut-off scores suggested for psychopathological problem behavior are 131 for the Intensity Score and 11 for the Problem Score (Eyberg, 1999).

  Change from baseline to 1 week post-program (13 weeks from baseline)

• Family Observation Scale, 6th Edition

  The FOS-6 measures both consistency and intensity of child and parent behavior. Coding systems use a Likert scale from 0-4 to record whether and how often a particular behavior occurred (0 = behavior did not occur and/or was of low intensity; 4 = occurred a lot and/or was of high intensity). Codes are identified according to different behavioral categories through global and interval coding. Observed parent behavior includes harsh parenting, lax parenting, and praise. Similarly, child behaviors are non-compliance, proactive oppositionality, complaint, and withdrawal. Frequency and intensity scores are calculating by summing the individual scores and then dividing by the total number of observation intervals. Final scores are then calculated from means to generate an overall rating as well as for each subscale (Sanders, 2000).

  Change from baseline to 1 week post-program (13 weeks from baseline)

Secondary Outcomes (9)

• Parent-Child Conflict Tactics Scale (CTSPC) (Straus et al., 1998)

  Change from baseline to 1 week post-program (13 weeks from baseline)

• Parenting Young Children Scale (PARYC)

  Change from baseline to 1 week post-program (13 weeks from baseline)

• Parenting Stress Index-Short Form, Distress Subscale

  Change from baseline to 1 week post-program (13 weeks from baseline)

• Beck Depression Inventory (BDI-II)

  Change from baseline to 1 week post-program (13 weeks from baseline)

• Multidimensional Scale of Perceived Social Support (MSPSS, 12-items)

  Change from baseline to 1 week post-program (13 weeks from baseline)

Other Outcomes (9)

• Implementation Fidelity

  Measured weekly over the 12 weeks of the program

• Program exposure, adherence, and engagement

  Measured weekly over the 12 weeks of the program

• Participant Satisfaction

  Measured weekly over the 12 weeks of the program

Study Arms (2)

Parenting Program

EXPERIMENTAL

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

Behavioral: Parenting Program

Wait-list control

NO INTERVENTION

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

Interventions

Parenting Program 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.

Also known as: Sinovuyo Caring Families Programme

Parenting Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cape Town: lead
• University of Oxford: collaborator
• Bangor University: collaborator
• Ilifa Labantwana: collaborator

Study Sites (1)

Ikamva Labantu Wellness Centre

Cape Town, Western Cape, 7784, South Africa

Location

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Catherine Ward, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

• Lucie Cluver, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: March 1, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 13, 2014

Record last verified: 2014-06

Locations

ZA (1)