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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
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.
- Conditions
- Child Maltreatment
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Nutritional guide for younger children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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.
- First posted28 May 2024
- Study start7 Jun 2024 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion5 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Parenting for Lifelong Health, Mikhulu Trust, Clowns Without Borders South Africa, Ministry of Primary and Secondary Education Zimbabwe
- Responsible party
- Principal investigator, Noreen Wini Dari, University of Cape Town
- Investigators
- Noreen Wini Dari, MSc, Principal investigator, University of Capetown
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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06431321
- Acronym / sponsor ID
- WNDNOR001
- Conditions
- Child Maltreatment
- Keywords
- Child Maltreatment, Parenting, Violence Against Children (VAC), Prevention, Parenting Intervention, Early Childhood Development (ECD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Parenting for Lifelong Health, Mikhulu Trust, Clowns Without Borders South Africa, Ministry of Primary and Secondary Education Zimbabwe
- Study start
- 7 Jun 2024 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 5 Sep 2024 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Each study arm will have 8 schools Schools will be randomly assigned to the study arm
| Arm | Type | Receives |
|---|---|---|
| Parent training intervention | Experimental | Behavioral: Tabudira Parenting Intervention for Early Childhood DevelopmentThe 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. |
| Control | Active comparator | Other: Nutritional guide for younger childrenThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Aged below 18
- A child enrolled in a school outside Harare Northern Central School District
- Child not enrolled in Early Childhood Development Grade A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tabudira Parenting Intervention for Early Childhood DevelopmentAlso: Parenting for Lifelong Health Young Children combined with Mikhulu Trust Book Sharing Programme - 2-Session Version2 session programme delivered weekly over 2 weeks using group-based delivery aimed at reducing child maltreatment, improving parenting behaviours and parent's mental health. | Behavioural | Parent training intervention |
| Nutritional guide for younger children2 session programme delivered weekly over 2 weeks aimed at providing parents with nutritional education to help provide maximum nutrition to the growing child | Other | Control |
Primary outcome
Changes in frequency of child maltreatment:
Time frame: 6 weeks
The International Child Abuse Screening Tool-Trial version (ICAST-T) measures the occurrence of respondents' discipline behaviour towards the child
7 secondary outcomes
Changes in attitudes towards harsh parenting
Time frame: 6 weeks
Changes in not knowing what to do when a child misbehaves
Time frame: 6 weeks
Spending time with child, praising, naming emotions
Time frame: 6 weeks
Changes in time spent engaging the child in book sharing
Time frame: 6 weeks
Changes in caregiver mental health
Time frame: 6 weeks
Changes in work-family conflict
Time frame: 6 weeks
Changes in Knowledge of Child nutrition
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: Yes. Ziva Hub Anonymised Individual Participant Data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noreen Wini Dari, MSc principal investigator
University of Capetown
1 site in 1 country: see every site and its status.
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.