NCT06431321

Brief 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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

June 7, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2024

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

May 8, 2024

Last Update Submit

May 28, 2024

Conditions

Keywords

Child MaltreatmentParentingViolence Against Children (VAC)PreventionParenting InterventionEarly Childhood Development (ECD)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Changes in attitudes towards harsh parenting

    6 weeks

  • Changes in not knowing what to do when a child misbehaves

    6 weeks

  • Spending time with child, praising, naming emotions

    6 weeks

  • Changes in time spent engaging the child in book sharing

    6 weeks

  • Changes in caregiver mental health

    6 weeks

  • +2 more secondary outcomes

Other Outcomes (1)

  • Implementation Outcomes

    6 weeks

Study Arms (2)

Parent training intervention

EXPERIMENTAL

The Tabudirira Parenting Intervention for Early Childhood Development will be delivered to parents of children aged 4-5 years in Harare, Zimbabwe. Trained facilitators will deliver the programme face to face, and a group of 15 parents will have 3 facilitators. The facilitators comprise of teachers working as guidance and counselling coordinators and psychology graduates. The programme consists of 2 sessions that will be delivered once a week over 2 weeks, with each session lasting 2.5 to 3 hours. The session will have various activities which focus on learning from each other and practising positive parenting behaviours. At the end of each session, parents will receive a home activity which allows them to practise the content taught during the session. At the end of session 2 parents will receive a parent handbook with the summary of the 2 sessions. Schools will be used as venues and the facilitators will receive ongoing mentoring and coaching during programme delivery.

Behavioral: Tabudira Parenting Intervention for Early Childhood Development

Control

ACTIVE COMPARATOR

The control group (8 groups with 15 parents each) will receive a one-hour session on nutrition with facilitators trained by a nutritionist focusing on children aged 4-7 years. The parents will also receive a nutrition handbook. Zimbabwe is faced with the triple burden of malnutrition: underweight, micronutrient deficiencies and overweight. There is an ongoing need to protect and promote diets, services and practices through a multi-systems approach that supports optimal nutrition, growth, and development for all children, using a parent support group can help achieve the goal. The nutrition programme has no components of positive parenting or links to the reduction of violence against children but will serve as a placebo control for the attention received by parents.

Other: Nutritional guide for younger children

Interventions

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.

Also known as: Parenting for Lifelong Health Young Children combined with Mikhulu Trust Book Sharing Programme - 2-Session Version
Parent training intervention

2 session programme delivered weekly over 2 weeks aimed at providing parents with nutritional education to help provide maximum nutrition to the growing child

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Aged below 18
  • A child enrolled in a school outside Harare Northern Central School District
  • Child not enrolled in Early Childhood Development Grade A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harare Northen Central School District

Harare, Zimbabwe

Location

Study Officials

  • Noreen Wini Dari, MSc

    University of Capetown

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noreen Wini Dari, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Research assistants and the statistician will be blinded until the analyses are completed. The randomisation process is concealed from research assistants in order to avoid experimenter bias. Complete statistical analysis plans will be prepared before the data is locked, and analysis tactics are predetermined. Until the data are finalised, the study statistician will not be aware of the treatment assignment
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Each study arm will have 8 schools Schools will be randomly assigned to the study arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 28, 2024

Study Start

June 7, 2024

Primary Completion

August 15, 2024

Study Completion

September 5, 2024

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Ziva Hub Anonymised Individual Participant Data

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
2026
Access Criteria
Open
More information

Locations