Child Behaviour Problems Clinical Trial
Official title:
Sinovuyo Caring Families Project
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.
| Status | Completed |
| Enrollment | 296 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| South Africa | Ikamva Lanbantu Enkululekweni Wellness Centre | Cape Town | Western Cape |
| Lead Sponsor | Collaborator |
|---|---|
| University of Cape Town | Bangor University, University of Oxford |
South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Eyberg Child Behavior Inventory | 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). | Baseline, post- intervention and 12-month post-intervention follow-up | No |
| Primary | Parenting Young Children Scale (Supporting Positive Behaviour subscale; Setting Limits subscale) | 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). | Baseline, post- intervention and 12-month post-intervention follow-up | No |
| Primary | Sinovuyo Observational Coding System | 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. | Baseline, post- intervention and 12-month post-intervention follow-up | No |
| Secondary | Beck Depression Inventory-II | Parental depression will be measured using the Beck Depression Inventory-II (BDI-II). The BDI-II is a 21-item scale with strong psychometric properties and prior use with multiple South African populations. | Baseline, post- intervention and 12-month post-intervention follow-up | No |
| Secondary | Parenting Stress Index Short Form | Parenting stress will be measured using the Parenting Stress Index (PSI) (36 items). This scale has been used widely throughout the world, including prior use in South African populations. Items are summed to create a total score. | Baseline, post- intervention and 12-month post-intervention follow-up | No |
| Secondary | Alabama Parenting Questionnaire (Poor monitoring/supervision subscale) | Parental monitoring and supervision will be measured using the Poor Monitoring/Supervision subscale (9 items) of the Alabama Parenting Questionnaire (APQ). Respondents are asked to select how often various actions (e.g., "Your child is home without adult supervision.") have happened in the past month on a 5-point Likert-like scale (1 = never; 5 = always). | Baseline, post- intervention and 12-month post-intervention follow-up | No |
| Secondary | Medical Outcome Study Social Support Survey (Emotional Support subscale) | Parent perceived social support will be measured using the emotional support subscale of the Medical Outcome Study Social Support Survey (MOS-SSS, 8-items). Parents report on the frequency of how often they receive emotional support (e.g., "someone you can count on to listen to when you need to talk") on a Likert-like scale of 1 to 5 (1 = none of the time; 5 = all of the time). Total scores are calculated by averaging the scores for each item and then transformed into a 0 to 100 scale. | Baseline, post- intervention and 12-month post-intervention follow-up | No |
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|---|---|---|---|
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