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Pilot Feasibility Trial of the Family Strengthening Intervention in Rwanda (FSI-R)

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ClinicalTrials.gov Identifier: NCT01509573
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : August 27, 2014
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Depressive Symptoms Anxiety Parenting Behavioral: Family Strengthening Intervention in Rwanda (FSI-R)

Detailed Description:
The challenge of this project is to develop a family-based intervention to prevent mental health problems in children affected by HIV/AIDS that can be initiated as caregivers come into contact with health systems via routine HIV testing and care. Specifically, we propose to develop and pilot test a prevention-oriented family-strengthening intervention to mitigate the mental health risks facing HIV/AIDS-affected children (i.e., those who are HIV+ themselves or who have an HIV+ family member, including those who have died). The intervention design, which is based upon the Family-Based Preventive Intervention (FBPI), is centrally focused on galvanizing mechanisms of resilience in children and families and building on local sources of strength. Our unique adaptation and pilot study will employ a family focus to attend to the reality that HIV/AIDS is a family disease, and to show that individual, familial, and community resources may help families to succeed despite chronic illness. The pilot intervention will use a randomized design, drawing study participants (N=80 families) from social work referrals. Protective factors characterizing the family and mental health problems in children and caregivers will be assessed pre- and post-intervention. In addition, we will survey both participants and interventionists to provide qualitative and quantitative data on the program's cultural acceptability and feasibility, and on their own satisfaction.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Family-Based Prevention of Mental Health Problems in HIV/AIDS-Affected Children (R34MH084679-01A1)
Study Start Date : July 2011
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria: All participants must be HIV/AIDS-affected (i.e., having an HIV+ family member, including those who have died). We will select single and dual caregiver families to reflect population dynamics in the area. Caregivers must be at least 18 years of age (the age of majority in Rwanda), must live in the same household as the children, and must be the child's legal guardian. Legal guardians may be aunts, uncles, grandparents, or foster parents. Caregivers must be willing to discuss HIV/AIDS with school-aged children in the family.

Exclusion Criteria: Potential participants will be excluded if they do not live in the Rwinkwavu catchment area. Untreated mental illness or active suicidal ideation/attempts in the family also constitutes exclusion criteria (mental health treatment for these problems may occur in conjunction with the FSI). HIV-positive children are ineligible for the study if their HIV status has not been disclosed to them. Exclusion criteria also include lack of caregiver willingness to discuss HIV/AIDS with school-aged children in the family. Youth-headed households will be excluded due to concerns about youth caregivers' capacity to participate in the FSI in addition to other caretaking duties.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509573

Partners In Health/Inshuti Mu Buzima (PIH/IMB)
Rwinkwavu, Rwanda
Sponsors and Collaborators
Harvard School of Public Health
Partners in Health
Harvard University
Boston Children’s Hospital
Principal Investigator: Theresa S Betancourt, ScD, MA Associate Professor, Harvard School of Public Health
More Information

Additional Information:

Responsible Party: Theresa Betancourt, Associate Professor of Child Health and Human Rights, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01509573     History of Changes
Other Study ID Numbers: RPCGA-FSI-15440
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014

Keywords provided by Theresa Betancourt, Harvard School of Public Health:
prevention therapy
depressive symptoms
family functioning
resilience, psychological
Developing countries

Additional relevant MeSH terms:
Behavioral Symptoms