CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 82 enrolled
Drug / intervention
Family Strengthening Intervention in Rwanda (FSI-R)behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01509573
NCT01509573N/ACompleted

Family-Based Prevention of Mental Health Problems in HIV/AIDS-Affected Children (R34MH084679-01A1)

Harvard School of Public Health (HSPH)·interventional·Posted Jan 13, 2012·Updated Aug 27, 2014

In Brief

A clinical study evaluating Family Strengthening Intervention in Rwanda (FSI-R) for Depressive Symptoms and 2 related conditions. Completed, enrolled 82 participants across 1 site.

Detailed Summary

The research will examine the following Specific Aims: Specific Aim 1: To adapt a U.S.-developed family-focused and strengths-based prevention program to the context of HIV/AIDS-affected families in Rwanda (the Family-Strengthening Intervention in Rwanda or "FSI-R") using prior qualitative findings and CAB input. Specific Aim 2: To deliver the intervention to a small group of families to collect preliminary data on intervention feasibility, acceptability, and to further refine the intervention manual for the FSI-R. Specific Aim 3: To conduct a pilot feasibility study of the FSI-R with 80 families. In pursuit of Specific Aim 3, this research will (a) conduct a preliminary exploratory analysis to examine the extent to which the FSI-R for HIV/AIDS-affected families is associated with improved caregiver-child relationships using measures of family connectedness, good parenting, and social support. Hypothesis 1: Participants in the FSI-R will demonstrate increases in protective processes compared to usual care controls not exposed to the FSI-R. It will also (b) conduct a preliminary exploratory analysis to determine the extent to which improved caregiver-child relationships are sustained four months after the conclusion of the FSI-R. Hypothesis 2: Four months after the conclusion of the intervention, participants in the FSI-R will demonstrate increases in protective processes compared to usual care controls not exposed to the FSI-R.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRwanda

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2012
Enrollment StartJul 1, 2011
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 14.5 years ago

Interventions

Family Strengthening Intervention in Rwanda (FSI-R)behavioral

Core components of the FSI-R are derived from the FBPI theoretical framework, and were chosen to address key risk factors identified in qualitative data. The FSI-R holds separate preliminary meetings with caregivers and children to prepare for a larger family meeting. In these modules, the interventionist helps caregivers and children prioritize concerns or key messages that they most want to share with the other party. Role play and discussions are used to impart improved parenting and communication skills. In the family meetings, children and caregivers share their concerns with one another and develop a shared family narrative, which integrates past events into a singular story with shared goals and a future orientation. These family modules also discuss the services and supports (formal and non-formal resources) that the family can engage with in order to achieve their shared goals. 8-12 weeks for 1-2 hours per week, depending on each family's pace and coverage of the material.