- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02165371
The Sinovuyo Caring Families Project: a Randomized Controlled Trial of a Parenting Programme
Sinovuyo Caring Families Project
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Western Cape
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Cape Town, Western Cape, South Africa, 7784
- Ikamva Lanbantu Enkululekweni Wellness Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sinovuyo Caring Families Programme
12-week group-based parenting program (Sinovuyo Caring Family Programme) delivered in weekly 3 hour sessions.
Program is manualized.
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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. |
No Intervention: No intervention
Control group receives not intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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Baseline, post- intervention and 12-month post-intervention follow-up
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Parenting Young Children Scale (Supporting Positive Behaviour subscale; Setting Limits subscale)
Time Frame: Baseline, post- intervention and 12-month post-intervention follow-up
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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).
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Baseline, post- intervention and 12-month post-intervention follow-up
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Sinovuyo Observational Coding System
Time Frame: Baseline, post- intervention and 12-month post-intervention follow-up
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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.
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Baseline, post- intervention and 12-month post-intervention follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory-II
Time Frame: Baseline, post- intervention and 12-month post-intervention follow-up
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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
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Parenting Stress Index Short Form
Time Frame: Baseline, post- intervention and 12-month post-intervention follow-up
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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.
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Baseline, post- intervention and 12-month post-intervention follow-up
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Alabama Parenting Questionnaire (Poor monitoring/supervision subscale)
Time Frame: Baseline, post- intervention and 12-month post-intervention follow-up
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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).
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Baseline, post- intervention and 12-month post-intervention follow-up
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Medical Outcome Study Social Support Survey (Emotional Support subscale)
Time Frame: Baseline, post- intervention and 12-month post-intervention follow-up
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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.
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Baseline, post- intervention and 12-month post-intervention follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Catherine Ward, PhD, University of Cape Town
- Principal Investigator: Lucie Cluver, DPhil, University of Oxford
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sinovuyo_RCT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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