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临床试验/NCT05948787
NCT05948787Enrolling By Invitation不适用

A Multi-site Randomized Controlled Trial: Testing the Feasibility and Effectiveness of the Strong Families Programme in the Philippines, Skills-based Prevention Intervention for Families With Children Ages 8-14 Years Old.

United Nations Office on Drugs and Crime (UNODC)10 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2023年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
210
试验地点
10
主要终点
Improved parenting skills

研究概览

简要总结

The Strong Families Programme was introduced by UNODC in the Philippines in 2018 through the training of facilitators. Twenty-six participants trained in the program from different cities and municipalities. Afterward, Caloocan, Marikina, Palawan, Pasig, and Quezon City Local Government Units (LGUs) started to train more facilitators to allow them to pilot the program in their communities. Eventually, these cities and municipalities managed to engage families to benefit from the Strong Families Programme.

The current study aims to explore the feasibility, effectiveness and acceptability of this universal prevention program with families in the Philippines, and the feasibility of delivering the program.

The primary objective will be to test the effectiveness of the Strong Families program in improving family skills outcomes and caregiver and child mental health, as reported by caregivers, when implemented in the Philippines.

The secondary objective will be to calculate the extent of family's attendance of Strong Families sessions, to evaluate completeness of program delivery.

The tertiary objective will be to explore the cultural and contextual acceptability of the Strong Families program for families in the Philippines.

A two-arm feasibility Randomized Controlled Trial with two arms: 1) Implementation of Strong Families (Intervention Group) and 2) Wait list/Control (Services-as-usual). This trial will have an embedded process evaluation.

This study will take place in five locations in the Philippines. The implementation usually happens at the Barangay Level (The smallest administrative division in the Philippines and is the native Filipino term for a village, district, or ward)

详细描述

Participants will be parents or caregivers and one child and up to two children under their care aged between 8-14 years. recruitment of the families will be done by the LGUs considering the opportunistic, 'universal' approach.

The study will be coordinated with the Anti-drug Abuse Councils at the Local Government Units (LGUs) of the five project sites supported by UNODC that mitigates the negative impact of COVID-19 on at-risk communities in the country. They will communicate the study with the Barangay Captains (Chief of the town) to advertise the study to their respective Barangays. Whether the study is announced via an online platform or through a traditional announcement (roving vehicle with a megaphone), or announcement posters, this will be arranged with the Barangay Captains.

Exclusion criteria

  • Families that have taken part in family skills training in the past 24 months
  • Families in which parent/caregiver live separately from children
  • Families in which parents/caregivers/children identified to have drug dependence

Intervention

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • Parent or caregivers that speak Filipino (Tagalog) with at least one child and up to two children under their care aged 8-14
  • Willing to take part in the program
  • Will be in town for the duration of the programme and research sessions

排除标准

  • Families that have taken part in family skills training in the past 24 months
  • Families in which parent/caregiver live separately from children
  • Families in which parents/caregivers/children identified to have drug dependence

结局指标

主要结局

Improved parenting skills

时间窗: three data time frames: 2 weeks post intervention, 3 weeks post intervention, and 6 weeks post intervention

Improved caregiver confidence in family management skills Improved caregiving in parenting skills Improved child behaviour Reduced aggressive and hostile behaviours Increased capacity to cope with stress Improved mental health outcomes in children and parents

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (10)

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