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Child MaltreatmentNCT06431321

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

A study testing Tabudira Parenting Intervention for Early Childhood Development and Nutritional guide for younger children in people with Child Maltreatment, run by University of Cape Town at 1 site in Zimbabwe.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Child Maltreatment
What is being tested?
Tabudira Parenting Intervention for Early Childhood Development and Nutritional guide for younger children
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteZimbabwe
Study dates
7 Jun 2024to 5 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Noreen Wini Dari, MSc contact

+263 718 886340

wndnor001@myuct.ac.za

Cathrine Ward, PhD contact

+27 21 650 3422

Catherine.Ward@uct.ac.za

Zimbabwe1 site
  • Harare Northen Central School District

    Harare

    Marian Mazingi District Official: Ministry of Primary and secondary Education, +263 772 864 277, mmazingi@ymail.com

Other trials in Zimbabwe

About this study

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

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?

Read the detailed 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.

Being tested
Tabudira Parenting Intervention for Early Childhood Development, Nutritional guide for younger children
Keywords
Child Maltreatment, Parenting, Violence Against Children (VAC), Prevention, Parenting Intervention, Early Childhood Development (ECD)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tabudira Parenting Intervention for Early Childhood DevelopmentBehavioural

    Also called Parenting for Lifelong Health Young Children combined with Mikhulu Trust Book Sharing Programme - 2-Session Version

    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.

  • Nutritional guide for younger childrenOther

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

Study groups in NCT06431321
Study groupRoleWhat they receive
Parent training interventionExperimentalThe 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.
Receives: Behavioral: Tabudira Parenting Intervention for Early Childhood Development
ControlActive comparatorThe 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.
Receives: Other: Nutritional guide for younger children

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 weeks

Secondary outcomes (7)
  1. 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?

    Measured: 6 weeks

  2. 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

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

  4. 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?

    Measured: 6 weeks

  5. 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

    Measured: 6 weeks

  6. 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.

    Measured: 6 weeks

  7. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start7 Jun 2024 (estimated)
  3. Primary completion15 Aug 2024 (estimated)
  4. Study completion5 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Each study arm will have 8 schools Schools will be randomly assigned to the study arm
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06431321
Sponsor's protocol ID
WNDNOR001
Status last verified
May 2024
First submitted
8 May 2024
Last updated
29 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Ziva Hub Anonymised Individual Participant Data

Questions about this trial

What is this clinical trial studying?

A study testing Tabudira Parenting Intervention for Early Childhood Development and Nutritional guide for younger children in people with Child Maltreatment, run by University of Cape Town at 1 site in Zimbabwe.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Noreen Wini Dari, MSc (+263 718 886340, wndnor001@myuct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in frequency of child maltreatment: (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.

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