Pilot Feasibility Trial of the Family Strengthening Intervention in Rwanda (FSI-R)
|ClinicalTrials.gov Identifier: NCT01509573|
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : August 27, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Depressive Symptoms Anxiety Parenting||Behavioral: Family Strengthening Intervention in Rwanda (FSI-R)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Family-Based Prevention of Mental Health Problems in HIV/AIDS-Affected Children (R34MH084679-01A1)|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: FSI-R (Intervention group)
The intervention group will participate in the mental health assessments and FSI-R, and will participate in post-intervention assessments and follow-up assessments.
Behavioral: Family Strengthening Intervention in Rwanda (FSI-R)
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.
No Intervention: TAU (Treatment as Usual)
The TAU control group will not receive any intervention, but will participate in treatment as usual as provided by Partners In Health. They will complete assessments at all three time points.
- Change from Baseline in Mental Health of Children and Caregivers [ Time Frame: Administered to caregivers and school-aged children in each cohort three times: once within 15 days prior to the start of the intervention, once within 15 days of intervention completion, and again 4 months following intervention completion. ]The Mental Health Assessment Batteries for Children and Caregivers are comprehensive surveys addressing a range of locally-relevant mental health problems and protective processes, as well as issues like functioning, stigma, hope, harsh parenting, parent-child relationships, and other risk and protective factors. The mental health components of the assessments have been subject to a validation study in this community. They were developed using qualitative data gathered from this population in 2007 and 2009.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509573
|Partners In Health/Inshuti Mu Buzima (PIH/IMB)|
|Principal Investigator:||Theresa S Betancourt, ScD, MA||Associate Professor, Harvard School of Public Health|