Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa

Depression Clinical Trial

Official title:

Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03231358
• Other study ID #: R01MH114843
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 21, 2018
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2023
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the efficacy of Our Family Our Future, an integrated intervention for preventing HIV and depression onset among adolescents.

Description:

Adolescent human immunodeficiency virus (HIV) and depression present significant public health challenges for South Africa, a country with the largest HIV epidemic globally and where structural factors including violence and poverty increase susceptibility for poor mental health. In families already experiencing psychological distress, adolescents face elevated risk for sexually transmitted infections (STIs) including HIV and depression. Preventive interventions are urgently needed during adolescence when risks for HIV, STIs, and depression in-crease exponentially. Preventive intervention strategies for adolescents should substantively involve families who can tailor prevention content to meet the unique needs of individual adolescents and reinforce formation and habituation of prevention behaviors. Moreover, evidence indicates common family risk and protective factors for adolescent HIV/STI risk behaviors and depression, underscoring the need for a family prevention approach. However, key gaps exist in family prevention science. In South Africa, few empirically supported family interventions integrate prevention of HIV/STI with depression for adolescents. This intervention (called Our Family Our Future) uses a resilience-oriented approach engages families in adolescent prevention from low-resource settings facing high adversity. The study will focus on adolescents (14-16 years) who are at an ideal developmental transition for family engagement in prevention. The age- and developmentally-tailored intervention - called Our Family Our Future - is based off of two empirically supported interventions that have been integrated and adapted to South Africa. In a pilot randomized trial, Our Family Our Future exhibited outstanding acceptability, feasibility and promising direction of effects including reductions of depressive symptoms; lower rates of sex; decreased unprotected sex; increased HIV testing; increased knowledge, motivation, intentions and self-efficacy for protective HIV/STI behaviors; improved family interactions; and increased resilience. Now investigators propose the next phase of this research program, an efficacy study of Our Family Our Future with three aims: (1) test the efficacy of the Our Family Our Future intervention in preventing HIV/STI acquisition among adolescents (14-16) with depressive symptoms by reducing HIV/STI risk behavior, and reducing depressive symptoms. The project will randomize N=880 adolescents to Our Family Our Future intervention or usual care with 6- and 12-month outcome assessments; (2) examine the extent to which the impact of the Our Family Our Future intervention is a) mediated by changes in resilience; behavioral skills; norms and attitudes relating to sex, condom use, gender; and family communication and functioning and b) moderated by the effect of sociodemographics, family HIV, and social protections; (3) identify barriers and facilitators to implementing Our Family Our Future within a large community-based organization setting with wide reach to provide data for future dissemination and scale-up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 880
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 16 Years

Eligibility

Inclusion Criteria:

• 14-16 years

• adolescent concurs that the adult identified is their parent (to also include primary caregivers in the pa-rental role)

• when more than one child in the family falls within the eligible age range, one child will be chosen at random

• lives in the household at least 4 days a week

Exclusion Criteria:

• no or low symptoms (<6) or clinically significant thresholds of depression (16+)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Depression
• Depressive Disorder
• HIV Infections
• Human Immunodeficiency Virus
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Our Family Our Future
Our Family Our Future is a 'selective' behavioral prevention program, designed to address HIV/STI acquisition, sexual risk behavior, and depression among adolescents (ages 14-16) in communities with high HIV prevalence and from families where adolescents and parents already exhibit mild, potentially troublesome, depressive symptoms but do not reach the threshold for further screening for a significant clinical depressive disorder. This intervention involves parent-child dyads who receive the intervention in a community setting, in a facilitated group format. The intervention is comprised of 3-hour sessions, held weekly for 3 consecutive weeks with an individual family meeting in the third or fourth week depending on family desires.

Locations

Country	Name	City	State
South Africa	Masiphumelele	Cape Town	Western Cape

Sponsors (5)

Lead Sponsor	Collaborator
Brown University	Desmond Tutu HIV Foundation, Medical Research Council, South Africa, Rhode Island Hospital, University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	treatment fidelity	We will gather data on treatment fidelity (what % of time the intervention facilitators abide by core elements of a standardized implementation protocol) to evaluate how rigorous the intervention is being implemented.	12 months
Other	intervention optimization	We examine recruitment, retention, and attrition data by examining how many participants are involved in each timepoint of data collection as compared to the original number of enrolled participants.	12 months
Other	intervention satisfaction	We examine how much participants like and dislike the intervention by gathering satisfaction data using likert scales on open responses.	12 months
Primary	incidence of composite HIV/STIs	We will examine whether the intervention produces reductions in HIV and STI incidence using biological tests for HIV, Chlamydia trachomatis, and Neisseria gonorrhoeae.	12 months
Primary	rates of sexual risk behavior	We will examine whether the intervention produces reductions in rates of actual and intended sexual risk behavior, as measured through the number of unprotected sex acts.	12 months
Primary	depressive symptoms	We will examine whether the intervention produces reductions in depressive symptoms. Depressive symptoms will be measured through symptom scores on the Center for Epidemiologic Studies Depression Scale - Child Version (CES-DC)	12 months
Secondary	Resilience	We examine whether resilience mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms. We measure resilience using a sum score on a resilience measure.	12 months
Secondary	protective sex behavioral skills	We examine whether protective sex behavioral skills - for condom use, sex refusal - mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.	12 months
Secondary	self efficacy for protective behavioral skills	We examine whether self efficacy for protective sex behavioral skills - for condom use, sex refusal - mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.	12 months
Secondary	intolerant or tolerant attitudes relating to sex, condom use, and gender equitable relationships	We examine whether attitudes around sex, condom use, and gender equity mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms. These are measured through likert scales.	12 months
Secondary	intolerant or tolerant social norms relating to sex, condom use, and gender equitable relationships	We examine whether intolerant or tolerant social norms around sex, condom use, and gender mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms. We measure these through likert scales.	12 months
Secondary	family communication	We examine whether family communication mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.	12 months
Secondary	access to social support	We examine whether social support - the the form of a sum score of social support on a social support measure called the Multidimensional Scale of Perceived Social Support - mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.	12 months
Secondary	Sociodemographic characteristics of the participant	We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of sociodemographics of the adolescent participant including gender, age, race and ethnicity.	12 months
Secondary	Sociodemographic characteristics of the parent	We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of sociodemographics of the parent including gender, age, race and ethnicity.	12 months
Secondary	Severity of parental depressive symptoms	We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of parental depressive symptoms as measured by the Center for Epidemiologic Studies Depression Scale.	12 months
Secondary	presence of HIV in the family	We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of family HIV including HIV infection among family members.	12 months
Secondary	orphanhood of adolescent participant	We examine whether the extent of impact of the intervention on outcomes is moderated by the adolescent participant's orphanhood status answered by a self-report item asking about orphanhood status, defined as maternal or paternal or double orphanhood.	12 months
Secondary	presence of food insecurity	We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of structural disparities such as the presence of food insecurity. We use a likert scale measure of food insecurity.	12 months
Secondary	receipt of social protection grants	We examine whether the extent of impact of the intervention on outcomes is moderated by the receipt of social protection grants as measured by self-report on whether the family receives any South African government social protection grants.	12 months