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临床试验/NCT06431321
NCT06431321尚未招募不适用

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

University of Cape Town1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年6月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
240
试验地点
1
主要终点
Changes in frequency of child maltreatment:

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

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.

干预措施: Nutritional guide for younger children (Other)

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.

干预措施: Tabudira Parenting Intervention for Early Childhood Development (Behavioral)

结局指标

主要结局

Changes in frequency of child maltreatment:

时间窗: 6 weeks

The International Child Abuse Screening Tool-Trial version (ICAST-T) measures the occurrence of respondents' discipline behaviour towards the child

次要结局

  • Changes in not knowing what to do when a child misbehaves(6 weeks)
  • Changes in caregiver mental health(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 work-family conflict(6 weeks)
  • Changes in attitudes towards harsh parenting(6 weeks)
  • Changes in Knowledge of Child nutrition(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noreen Wini Dari

Principal Investigator

University of Cape Town

研究点 (1)

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