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The Sinovuyo Caring Families Project: a Randomized Controlled Trial of a Parenting Programme

Primary Purpose

Child Behaviour Problems

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Sinovuyo Caring Families Programme
Sponsored by
University of Cape Town
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child Behaviour Problems

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ikamva Lanbantu Enkululekweni Wellness Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sinovuyo Caring Families Programme

No intervention

Arm Description

12-week group-based parenting program (Sinovuyo Caring Family Programme) delivered in weekly 3 hour sessions. Program is manualized.

Control group receives not intervention

Outcomes

Primary Outcome Measures

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).
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).
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.

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
June 12, 2014
Last Updated
December 8, 2016
Sponsor
University of Cape Town
Collaborators
University of Oxford, Bangor University
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1. Study Identification

Unique Protocol Identification Number
NCT02165371
Brief Title
The Sinovuyo Caring Families Project: a Randomized Controlled Trial of a Parenting Programme
Official Title
Sinovuyo Caring Families Project
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town
Collaborators
University of Oxford, Bangor University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behaviour Problems

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sinovuyo Caring Families Programme
Arm Type
Experimental
Arm Description
12-week group-based parenting program (Sinovuyo Caring Family Programme) delivered in weekly 3 hour sessions. Program is manualized.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Control group receives not intervention
Intervention Type
Behavioral
Intervention Name(s)
Sinovuyo Caring Families Programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eyberg Child Behavior Inventory
Description
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).
Time Frame
Baseline, post- intervention and 12-month post-intervention follow-up
Title
Parenting Young Children Scale (Supporting Positive Behaviour subscale; Setting Limits subscale)
Description
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).
Time Frame
Baseline, post- intervention and 12-month post-intervention follow-up
Title
Sinovuyo Observational Coding System
Description
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.
Time Frame
Baseline, post- intervention and 12-month post-intervention follow-up
Secondary Outcome Measure Information:
Title
Beck Depression Inventory-II
Description
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.
Time Frame
Baseline, post- intervention and 12-month post-intervention follow-up
Title
Parenting Stress Index Short Form
Description
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.
Time Frame
Baseline, post- intervention and 12-month post-intervention follow-up
Title
Alabama Parenting Questionnaire (Poor monitoring/supervision subscale)
Description
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).
Time Frame
Baseline, post- intervention and 12-month post-intervention follow-up
Title
Medical Outcome Study Social Support Survey (Emotional Support subscale)
Description
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.
Time Frame
Baseline, post- intervention and 12-month post-intervention follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Ward, PhD
Organizational Affiliation
University of Cape Town
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucie Cluver, DPhil
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ikamva Lanbantu Enkululekweni Wellness Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7784
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
31535371
Citation
Ward CL, Wessels IM, Lachman JM, Hutchings J, Cluver LD, Kassanjee R, Nhapi R, Little F, Gardner F. Parenting for Lifelong Health for Young Children: a randomized controlled trial of a parenting program in South Africa to prevent harsh parenting and child conduct problems. J Child Psychol Psychiatry. 2020 Apr;61(4):503-512. doi: 10.1111/jcpp.13129. Epub 2019 Sep 19.
Results Reference
derived

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The Sinovuyo Caring Families Project: a Randomized Controlled Trial of a Parenting Programme

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