Evaluation of a 2-session Parent Training Programme for Caregivers of Younger Children in Zimbabwe

Child Maltreatment Clinical Trial

Official title:

A Pilot Cluster Randomised Controlled Trial of a Two-session Parent Training Programme for Delivery to Caregivers of Children Enrolled in Early Childhood Development in Harare, Zimbabwe

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06431321
• Other study ID #: WNDNOR001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 7, 2024
• Est. completion date: September 5, 2024

Study information

• Verified date: May 2024
• Source: University of Cape Town
• Contact: Noreen Wini Dari, MSc
• Phone: +263 718 886340
• Email: wndnor001[@]myuct.ac.za
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A pilot, exploratory cluster Randomised Controlled Trial (RCT) with two arms will be conducted to test a two-session parent training programme for caregivers of children enrolled in early childhood development classes in Harare Zimbabwe. The Parenting for Lifelong Health programme for Young Children together with the Mikhulu Trust Book Sharing Programme for Young Children will be adapted into a two-session version programme named Tabudirira Parent Training Intervention for Early Childhood Development.

The RCT aims to assess the following objectives:

Can the programme reduce child maltreatment? Does the intervention improve parent-child engagement with reading material? How best can the 2-session programme delivery be optimised?

Description:

A pilot, exploratory cluster Randomised Controlled Trial (RCT) with two arms will be conducted to test a two-session parent training programme for caregivers of children enrolled in early childhood development classes in Harare, Zimbabwe. The Parenting for Lifelong Health programme for Young Children together with the Mikhulu Trust Book Sharing Programme for Young Children will be adapted into a two-session version programme named Tabudirira Parent Training Intervention for Early Childhood Development.

The RCT aims to assess the following objectives:

Can the programme reduce child maltreatment? Does the intervention improve parent-child engagement with reading material? How best can the 2-session programme delivery be optimised?

The RCt will have 2 arms with 120 caregivers /arms. The intervention will be a 2-session parent training programme while the control is a 2-session nutrition knowledge dissemination workshop delivered over 2 sessions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: September 5, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years and above.

• Be a caregiver to a child enrolled in Early Childhood Development Grade A at a school in Harare Northern Central School district.

• Live with the child for a minimum of 5 days/ week.

• Provide informed consent before any study proceedings.

Exclusion Criteria

• Aged below 18

• A child enrolled in a school outside Harare Northern Central School District

• Child not enrolled in Early Childhood Development Grade A

Related Conditions & MeSH terms

• Child Maltreatment

Intervention

Behavioral:
• Tabudira Parenting Intervention for Early Childhood Development
2 session programme delivered weekly over 2 weeks using group-based delivery aimed at reducing child maltreatment, improving parenting behaviours and parent's mental health.

Other:
• Nutritional guide for younger children
2 session programme delivered weekly over 2 weeks aimed at providing parents with nutritional education to help provide maximum nutrition to the growing child

Locations

Country	Name	City	State
Zimbabwe	Harare Northen Central School District	Harare

Sponsors (5)

Lead Sponsor	Collaborator
University of Cape Town	Clowns Without Borders South Africa, Mikhulu Trust, Ministry of Primary and Secondary Education Zimbabwe, Parenting for Lifelong Health

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implementation Outcomes	Barriers and enablers to delivery Barriers and enablers to parent engagement (attendance, homework completion)	6 weeks
Primary	Changes in frequency of child maltreatment:	The International Child Abuse Screening Tool-Trial version (ICAST-T) measures the occurrence of respondents' discipline behaviour towards the child	6 weeks
Secondary	Changes in attitudes towards harsh parenting	Changes in attitudes towards harsh parenting will be measured using two items from the ICAST-T measure used in measuring the primary outcome. The questions will seek to understand parental attitudes towards harsh discipline for example: In the past 6 weeks, how often did physical discipline seem like the only option for stopping bad behaviour?	6 weeks
Secondary	Changes in not knowing what to do when a child misbehaves	will be measured using 1 item from the ICAST-T the question: In the past 6 weeks, how often did you not know what to do when your child misbehaved	6 weeks
Secondary	Spending time with child, praising, naming emotions	The Parenting Young Children Questionnaire (PARYC) has 9 items that contain statements of parenting behaviours that caregivers rate on a Likert scale from 1 (not at all) to 7 (most of the time). Two dimensions of the PARYC will be measured: Supporting Good Behaviour (e.g., "Notice/Praise good behaviour") and Setting Limits (e.g., "Stick to your rules"). The items included in the current questionnaire (Cronbach alpha 0.86). are informed by the metric invariance analysis of the measure done in a preceding study, pending publication. The preceding study measured the prevalence of violence against children and its correlates. The highest possible score is 63 indicating more parent-child engagement compared to the lowest possible score of 9 indicating fewer parent-child engagements.	6 weeks
Secondary	Changes in time spent engaging the child in book sharing	Two items, similar in structure to those in the PARYC, will be used to assess this e.g. How often do you spend time book sharing with your child?	6 weeks
Secondary	Changes in caregiver mental health	The Shona Symptoms Questionnaire (SSQ-14) will be used to assess parental mental health before and after the programme. The SSQ is a 14-item screening tool for common mental disorders and has a reliable internal consistency (0.85). It asks about symptoms such as thinking too much, failing to concentrate, work lagging, insomnia, suicidal ideation, unhappiness and so on, over 1 week. Highest total possible score of 14 indicates floundering parental mental health while a score of 0 indicates flourishing parental mental health	6 weeks
Secondary	Changes in work-family conflict	The Multidimensional Measure of Work-Family Conflict (MMWFC) measures work-family conflict on three constructs: time, strain and behaviour. The scale has 12 items, with responses on a 7-point Likert scale ranging from strongly disagree to strongly agree. The following are examples of items in the questionnaire: my work keeps me from my family activities more than I would like, I am often stressed from my family responsibilities, and I have a hard time concentrating on my work. The internal reliability was 0.92 in phase 1. The highest possible score is 84 indicating increased work-family conflict compared to 12 which is the lowest possible score indicating better work-family balance.	6 weeks
Secondary	Changes in Knowledge of Child nutrition	: Four questions will be adapted from the Food and Agriculture Organisation of the United Nations guidelines for assessing nutrition-related knowledge, attitudes, and practices. The questions will assess the practices of the child's intake of healthy (2 items) and unhealthy snacks (2 items): How many times a day does your child eat candy? The items will be measured on a 6-point Likert scale ranging from Never to 6 times a day. The healthy eating scores will be reverse scored. The highest possible total is 24 indicating poor snacking practices compared to the lowest possible score of 4 for healthy snacking practices.	6 weeks