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Clinical Trials/NCT02165371
NCT02165371
Completed
Not Applicable

Sinovuyo Caring Families Project

University of Cape Town1 site in 1 country296 target enrollmentStarted: February 2014Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
296
Locations
1
Primary Endpoint
Eyberg Child Behavior Inventory

Overview

Brief Summary

It has been established that children in families affected by either intimate partner violence or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) are at substantially increased risk of poor parenting and child maltreatment. In the sub-Saharan African context of high levels of HIV/AIDS and family violence, it is crucial that parents be supported to establish positive parenting practices and reduce harsh or abusive parenting within their families.This randomized controlled trial will be testing the Sinovuyo Caring Families Program (n = 296), a 12-session (2.5 hour per session) parenting intervention for primary caregivers of children between 2 and 9 years old. Participants will not be restricted to biological parents and include primary caregivers of children between 2 and 9 years old, who live in the same house as the child at least 4 nights per week. Participants will be recruited through systematic household sampling, liaising with Western Cape Department of Social Development and local community-based NGOs. Self-reporting questionnaires and qualitative observational assessment data for intervention and control groups will be collected at pre- and post-test evaluation as well as 12-month follow-up. Primary outcomes will include child behaviour problems, harsh and inconsistent parenting and positive parenting. Secondary outcomes will include parental depression, parental stress, parental monitoring and supervision and parent perceived social support.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Caregiver must live with child at least 4 nights per week
  • Child must be between 2 and 9 years old Live in Khayelitsha or Nyanga
  • May include biological parents, relatives or non-kin foster caregivers, with no restrictions on biological relationship
  • Participant must self-identify as the primary caretaker of the child
  • Children scoring 15 or higher in the Eyberg Child Behaviour Inventory problem scale

Exclusion Criteria

  • Children scoring 14 or lower in the Eyber Child Behaviour Inventory problem scale
  • Participants with child not between 2 and 9 years old
  • Participants not self-identifying as the primary care take of the child
  • Participants not living with the child at least 4 nights per week.

Outcomes

Primary Outcomes

Eyberg Child Behavior Inventory

Time Frame: Baseline, post- intervention and 12-month post-intervention follow-up

This 36-item examines externalising behaviour 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).

Parenting Young Children Scale (Supporting Positive Behaviour subscale; Setting Limits subscale)

Time Frame: Baseline, post- intervention and 12-month post-intervention follow-up

Parental self-report of positive parenting will be assessed with the Parenting Young Children Scale (PARYC) subscales for supportive positive behaviour and setting limits. The PARYC (21 items total) measures the occurrence of specific parental behaviour towards children during the previous month on a 7-point Likert scale (0 = never; 6 = always), as well as whether performing this behaviour is currently a problem or difficult (0 = no; 1 = yes).

Sinovuyo Observational Coding System

Time Frame: Baseline, post- intervention and 12-month post-intervention follow-up

This study will also conduct observational assessments of child behaviour using the Sinovuyo Observational Coding System (SOCS). This coding system is based on the Dyadic Parent- Child Interaction Coding System, but has been adapted to be simpler and quicker to use. This tool was developed during the pilot RCT of the Sinovuyo Caring Families Programme to provide a valid and reliable means of coding the behavioural categories that the programme aims to address.

Secondary Outcomes

  • Beck Depression Inventory-II(Baseline, post- intervention and 12-month post-intervention follow-up)
  • Alabama Parenting Questionnaire (Poor monitoring/supervision subscale)(Baseline, post- intervention and 12-month post-intervention follow-up)
  • Medical Outcome Study Social Support Survey (Emotional Support subscale)(Baseline, post- intervention and 12-month post-intervention follow-up)
  • Parenting Stress Index Short Form(Baseline, post- intervention and 12-month post-intervention follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Catherine L. Ward

Principal Investigator

University of Cape Town

Study Sites (1)

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