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临床试验/NCT05071924
NCT05071924已完成不适用

Parenting for Lifelong Health for Teens - Hybrid Delivery

University of Oxford1 个研究点 分布在 1 个国家目标入组 1,128 人开始时间: 2021年7月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,128
试验地点
1
主要终点
Child Maltreatment: ISPCAN Child Abuse Screening Tools-Trial Version - Parent Report

研究概览

简要总结

This study aims to examine the implementation and effectiveness of the original version of PLH Teens delivered in-person (PLH Teens-Original) and a hybrid in-person and remote delivery of the programme (PLH Teens-Hybrid) as part of the Mothers2Mothers' (M2M) Children and Adolescents are My Priority (CHAMP) project in Mpumalanga, South Africa. It will also examine differential effects between PLH Teens-Original and PLH Teens-Hybrid on reducing risks of violence against children using propensity score matching. Lastly, it will examine the implementation feasibility of PLH Teens-Hybrid in terms of implementation fidelity; recruitment, retention, and engagement of parents and adolescents; and the relevance, acceptability, and satisfaction of the programme.

详细描述

Study Design This study will use a mixed-methods approach to qualitatively and quantitatively address the research aims. It will be implemented from May to July 2021 in the Mpumalanga province of South Africa. The study design will involve a) pre-post quantitative analyses of primary and secondary outcomes for both PLH Teens-Original and PLH Teens-Hybrid, b) difference in analyses to compare effects between the two delivery modalities, and c) qualitative interviews and quantitative analyses of programme feasibility and implementation.

Recruitment Recruitment of parents/caregivers and adolescents will be integrated into CHAMP's current recruitment strategy which includes engaging with schools, faith-based organisations, local NGOs, health facilities, United States Agency for International Development (USAID) DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) partners, door-to-door engagement and other contextually relevant approaches. CHAMP leverages its partnerships for recruitment and the CHAMP partner, Grassroots Soccer, actively engages in recruitment for the DREAMS programme. Participants enrolled into the hybrid PLH programme will be screened using the USAID approved Vulnerability Assessment Tool to ensure that the most vulnerable households are reached. The pilot will target caregivers in the Nelspruit area to ensure adequate access to internet connectivity.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for participating parents or caregivers:
  • •Any person over the age of 18 currently caring for a child between the ages of 10 and 17
  • •Has the ability to attend the in-person parenting support group (PLH Teens-Original)
  • •Has access to a WhatsApp compatible smartphone and is willing to join an online parenting support group (PLH Teens-Hybrid)
  • •Has provided consent to participate in the study
  • •Inclusion criteria for teens:
  • •Must be between the age of 10 and 17
  • •Has a parent or caregiver who is participating in the programme
  • •Parent has provided consent to participate in the study
  • •Has provided assent to participate in the study
  • •Inclusion criteria for facilitators:
  • •The facilitator must be over the age of 18
  • •Has completed a facilitator training workshop specifically for the PLH-Teens hybrid delivery prior to intervention delivery
  • •Is able to access the in-person session location
  • •Has a smart-phone or device capable of delivering the programme via an online platform such as WhatsApp or Viber
  • •Has provided informed consent to participate in the study

排除标准

  • 未提供

研究组 & 干预措施

PLH Teens Original

Experimental

The original in-person PLH programme is delivered by community-based workers in low-resource settings. Implementation occurs in a group-based format with both joint parent and teen sessions (10 sessions) and separate parent and teen sessions (4 sessions).

干预措施: PLH Teens Original: In-person PLH programme for parents and teens by community-based workers (Behavioral)

PLH Teens Hybrid

Experimental

The hybrid delivery of PLH Teens consists of 8 sessions delivered to parents via WhatsApp (ParentChat-Teens) and 4 sessions delivered to parents and adolescents in person.

干预措施: PLH Teens Hybrid: Hybrid delivery for parents and teens by facilitators (Behavioral)

结局指标

主要结局

Child Maltreatment: ISPCAN Child Abuse Screening Tools-Trial Version - Parent Report

时间窗: Change between Baseline and Post (approx. 4 months post-baseline)

Child maltreatment will be assessed using a shortened version of the ISPCAN Child Abuse Screening Tools-Trial Version (9-item subscale ICAST-T). Parent respondents will be asked to indicate the frequency of emotional and physical discipline practices over the past month using a 9-point frequency count scale (0 = never; 8 = 8 or more times). Items include, "In the past 4 weeks, how often did you/your caregiver discipline your child/you by spanking, slapping or hitting with a hand?" and "In the past 4 weeks, how often did you/your caregiver shout, yell or scream at you?" In the past 4 weeks, how often did you/your caregiver discipline your child/you with an object like a stick or a belt?". Items are summed, with higher scores indicating greater use of harsh parenting.

Child Maltreatment: ISPCAN Child Abuse Screening Tools-Trial Version - Teen Report

时间窗: Change between Baseline and Post (approx. 4 months post-baseline)

Child maltreatment will be assessed using a shortened version of the ISPCAN Child Abuse Screening Tools-Trial Version (9-item subscale ICAST-T). Teen respondents will be asked to indicate the frequency of emotional and physical discipline practices over the past month using a 9-point frequency count scale (0 = never; 8 = 8 or more times). Items include, "In the past 4 weeks, how often did you/your caregiver discipline your child/you by spanking, slapping or hitting with a hand?" and "In the past 4 weeks, how often did you/your caregiver shout, yell or scream at you?" In the past 4 weeks, how often did you/your caregiver discipline your child/you with an object like a stick or a belt?". Items are summed, with higher scores indicating greater use of harsh parenting.

次要结局

  • Parenting Stress: Parenting Stress Scale(Change between Baseline and Post (approx. 4 months post-baseline))
  • Positive Parenting: Alabama Parenting Questionnaire - Teen Report(Change between Baseline and Post (approx. 4 months post-baseline))
  • Risk Avoidance: Risk Avoidance Planning Scale - Parent Report(Change between Baseline and Post (approx. 4 months post-baseline))
  • Attitude Toward Punishment: UNICEF Multiple Indicator Cluster Survey (MICS) 5 Child Discipline Module - Teen Report(Change between Baseline and Post (approx. 4 months post-baseline))
  • Attitude Toward Punishment: UNICEF Multiple Indicator Cluster Survey (MICS) 5 Child Discipline Module - Parent Report(Change between Baseline and Post (approx. 4 months post-baseline))
  • Child Behaviour Problems: Strengths and Difficulties Questionnaire - Teen Report(Change between Baseline and Post (approx. 4 months post-baseline))
  • Economic Strengthening: Family Financial Coping Scale - Teen Report(Change between Baseline and Post (approx. 4 months post-baseline))
  • Parent Support of Education: Parental Support for School Scale - Parent Report(Change between Baseline and Post (approx. 4 months post-baseline))
  • Child Maltreatment - Physical Abuse and Emotional Abuse: ISPCAN Child Abuse Screening Tool-Intervention (ICASTTP) - Physical and Emotional Abuse Subscales(Change between Baseline and Post (approx. 4 months post-baseline))
  • Positive Parenting: Alabama Parenting Questionnaire - Parent Report(Change between Baseline and Post (approx. 4 months post-baseline))
  • Child Behaviour Problems: Strengths and Difficulties Questionnaire - Parent Report(Change between Baseline and Post (approx. 4 months post-baseline))
  • Parental Depression: Centre for Epidemiologic Studies Depression Scale - Parent Report(Change between Baseline and Post (approx. 4 months post-baseline))
  • Teens Internalising Behaviours: Strength and Difficulties Questionnaire (SDQ) - Parent Report(Change between Baseline and Post (approx. 4 months post-baseline))
  • Economic Strengthening: Family Financial Coping Scale - Parent Report(Change between Baseline and Post (approx. 4 months post-baseline))
  • Parent Support of Education: Parental Support for School Scale - Teen Report(Change between Baseline and Post (approx. 4 months post-baseline))
  • Risk Avoidance: Risk Avoidance Planning Scale - Teen Report(Change between Baseline and Post (approx. 4 months post-baseline))

研究者

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

DrJamieLachman

Principal Investigator

University of Oxford

研究点 (1)

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