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

NCT01509573 | Completed DMC

• 1 other identifier: RPCGA-FSI-15440
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Anxiety; Parenting

Keywords

prevention therapy; depressive symptoms; anxiety; parenting; family functioning; resilience, psychological; Developing countries; Rwanda; HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Mental Health of Children and Caregivers

  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.

  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.

Study Arms (2)

FSI-R (Intervention group)

EXPERIMENTAL

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)

TAU (Treatment as Usual)

NO INTERVENTION

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.

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.

FSI-R (Intervention group)

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Partners in Health: collaborator
• Harvard University: collaborator
• Boston Children's Hospital: collaborator

Study Sites (1)

Partners In Health/Inshuti Mu Buzima (PIH/IMB)

Rwinkwavu, Rwanda

Location

Related Publications (23)

• Beardslee WR. Prevention and the clinical encounter. Am J Orthopsychiatry. 1998 Oct;68(4):521-33. doi: 10.1037/h0080361.

  PMID: 9809112 BACKGROUND

• Beardslee WR, Gladstone TR, Wright EJ, Cooper AB. A family-based approach to the prevention of depressive symptoms in children at risk: evidence of parental and child change. Pediatrics. 2003 Aug;112(2):e119-31. doi: 10.1542/peds.112.2.e119.

  PMID: 12897317 BACKGROUND

• Beardslee WR, Salt P, Versage EM, Gladstone TR, Wright EJ, Rothberg PC. Sustained change in parents receiving preventive interventions for families with depression. Am J Psychiatry. 1997 Apr;154(4):510-5. doi: 10.1176/ajp.154.4.510.

  PMID: 9090338 BACKGROUND

• Beardslee WR, Wright E, Rothberg PC, Salt P, Versage E. Response of families to two preventive intervention strategies: long-term differences in behavior and attitude change. J Am Acad Child Adolesc Psychiatry. 1996 Jun;35(6):774-82. doi: 10.1097/00004583-199606000-00017.

  PMID: 8682758 BACKGROUND

• Betancourt TS, Meyers-Ohki S, Stulac SN, Barrera AE, Mushashi C, Beardslee WR. Nothing can defeat combined hands (Abashize hamwe ntakibananira): protective processes and resilience in Rwandan children and families affected by HIV/AIDS. Soc Sci Med. 2011 Sep;73(5):693-701. doi: 10.1016/j.socscimed.2011.06.053. Epub 2011 Jul 23.

  PMID: 21840634 BACKGROUND

• Tol WA, Barbui C, Galappatti A, Silove D, Betancourt TS, Souza R, Golaz A, van Ommeren M. Mental health and psychosocial support in humanitarian settings: linking practice and research. Lancet. 2011 Oct 29;378(9802):1581-91. doi: 10.1016/S0140-6736(11)61094-5. Epub 2011 Oct 16.

  PMID: 22008428 BACKGROUND

• Betancourt TS, Borisova II, de la Soudiere M, Williamson J. Sierra Leone's child soldiers: war exposures and mental health problems by gender. J Adolesc Health. 2011 Jul;49(1):21-8. doi: 10.1016/j.jadohealth.2010.09.021. Epub 2010 Dec 24.

  PMID: 21700152 BACKGROUND

• Betancourt TS. Attending to the mental health of war-affected children: the need for longitudinal and developmental research perspectives. J Am Acad Child Adolesc Psychiatry. 2011 Apr;50(4):323-5. doi: 10.1016/j.jaac.2011.01.008. No abstract available.

  PMID: 21421171 BACKGROUND

• Betancourt TS, Borisova II, Williams TP, Brennan RT, Whitfield TH, de la Soudiere M, Williamson J, Gilman SE. Sierra Leone's former child soldiers: a follow-up study of psychosocial adjustment and community reintegration. Child Dev. 2010 Jul-Aug;81(4):1077-95. doi: 10.1111/j.1467-8624.2010.01455.x.

  PMID: 20636683 BACKGROUND

• Betancourt TS, Brennan RT, Rubin-Smith J, Fitzmaurice GM, Gilman SE. Sierra Leone's former child soldiers: a longitudinal study of risk, protective factors, and mental health. J Am Acad Child Adolesc Psychiatry. 2010 Jun;49(6):606-15. doi: 10.1016/j.jaac.2010.03.008. Epub 2010 May 1.

  PMID: 20494270 BACKGROUND

• Betancourt TS, Agnew-Blais J, Gilman SE, Williams DR, Ellis BH. Past horrors, present struggles: the role of stigma in the association between war experiences and psychosocial adjustment among former child soldiers in Sierra Leone. Soc Sci Med. 2010 Jan;70(1):17-26. doi: 10.1016/j.socscimed.2009.09.038. Epub 2009 Oct 28.

  PMID: 19875215 BACKGROUND

• Betancourt TS, Simmons S, Borisova I, Brewer SE, Iweala U, Soudiere MD. High Hopes, Grim Reality: Reintegration and the Education of Former Child Soldiers in Sierra Leone. Comp Educ Rev. 2008 Nov 1;52(4):565-587. doi: 10.1086/591298. No abstract available.

  PMID: 19337570 BACKGROUND

• Betancourt TS, Bass J, Borisova I, Neugebauer R, Speelman L, Onyango G, Bolton P. Assessing local instrument reliability and validity: a field-based example from northern Uganda. Soc Psychiatry Psychiatr Epidemiol. 2009 Aug;44(8):685-92. doi: 10.1007/s00127-008-0475-1. Epub 2009 Jan 22.

  PMID: 19165403 BACKGROUND

• Verdeli H, Clougherty K, Onyango G, Lewandowski E, Speelman L, Betancourt TS, Neugebauer R, Stein TR, Bolton P. Group Interpersonal Psychotherapy for depressed youth in IDP camps in Northern Uganda: adaptation and training. Child Adolesc Psychiatr Clin N Am. 2008 Jul;17(3):605-24, ix. doi: 10.1016/j.chc.2008.03.002.

  PMID: 18558315 BACKGROUND

• Bolton P, Bass J, Betancourt T, Speelman L, Onyango G, Clougherty KF, Neugebauer R, Murray L, Verdeli H. Interventions for depression symptoms among adolescent survivors of war and displacement in northern Uganda: a randomized controlled trial. JAMA. 2007 Aug 1;298(5):519-27. doi: 10.1001/jama.298.5.519.

  PMID: 17666672 BACKGROUND

• Betancourt TS, Speelman L, Onyango G, Bolton P. A qualitative study of mental health problems among children displaced by war in northern Uganda. Transcult Psychiatry. 2009 Jun;46(2):238-56. doi: 10.1177/1363461509105815.

  PMID: 19541749 BACKGROUND

• Betancourt TS, Khan KT. The mental health of children affected by armed conflict: protective processes and pathways to resilience. Int Rev Psychiatry. 2008 Jun;20(3):317-28. doi: 10.1080/09540260802090363.

  PMID: 18569183 BACKGROUND

• Betancourt TS. Child soldiers: reintegration, pathways to recovery, and reflections from the field. J Dev Behav Pediatr. 2008 Apr;29(2):138-41. doi: 10.1097/DBP.0b013e31816be946. No abstract available.

  PMID: 18408537 BACKGROUND

• Betancourt TS, Williams T. Building an evidence base on mental health interventions for children affected by armed conflict. Intervention (Amstelveen). 2008;6(1):39-56. doi: 10.1097/WTF.0b013e3282f761ff.

  PMID: 19997531 BACKGROUND

• Betancourt T, Scorza P, Meyers-Ohki S, Mushashi C, Kayiteshonga Y, Binagwaho A, Stulac S, Beardslee WR. Validating the Center for Epidemiological Studies Depression Scale for Children in Rwanda. J Am Acad Child Adolesc Psychiatry. 2012 Dec;51(12):1284-92. doi: 10.1016/j.jaac.2012.09.003. Epub 2012 Nov 8.

  PMID: 23200285 BACKGROUND

• Scorza P, Stevenson A, Canino G, Mushashi C, Kanyanganzi F, Munyanah M, Betancourt T. Validation of the "World Health Organization Disability Assessment Schedule for children, WHODAS-Child" in Rwanda. PLoS One. 2013;8(3):e57725. doi: 10.1371/journal.pone.0057725. Epub 2013 Mar 7.

  PMID: 23505437 BACKGROUND

• Betancourt TS, Meyers-Ohki SE, Charrow A, Hansen N. Annual Research Review: Mental health and resilience in HIV/AIDS-affected children-- a review of the literature and recommendations for future research. J Child Psychol Psychiatry. 2013 Apr;54(4):423-44. doi: 10.1111/j.1469-7610.2012.02613.x. Epub 2012 Sep 4.

  PMID: 22943414 BACKGROUND

• Betancourt TS, Ng LC, Kirk CM, Brennan RT, Beardslee WR, Stulac S, Mushashi C, Nduwimana E, Mukunzi S, Nyirandagijimana B, Kalisa G, Rwabukwisi CF, Sezibera V. Family-based promotion of mental health in children affected by HIV: a pilot randomized controlled trial. J Child Psychol Psychiatry. 2017 Aug;58(8):922-930. doi: 10.1111/jcpp.12729. Epub 2017 May 15.

  PMID: 28504307 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Theresa S Betancourt, ScD, MA

  Associate Professor, Harvard School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Child Health and Human Rights

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 13, 2012
• Study Start: July 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 27, 2014

Record last verified: 2014-08

Locations

RW (1)