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Clinical Trials/NCT05948787
NCT05948787Enrolling By InvitationNot Applicable

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 sites in 1 country210 target enrollmentStarted: February 28, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
210
Locations
10
Primary Endpoint
Improved parenting skills

Study Overview

Brief Summary

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)

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

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

Outcomes

Primary Outcomes

Improved parenting skills

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (10)

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