Our Family Our Future: Acceptability and Feasibility Study of a Family Prevention Program for HIV Risk and Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the feasibility and acceptability of a family-based preventive intervention designed to reduce sexual risk behaviors and depressive symptoms among South African adolescents and their parents/guardians/caregivers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03231358

Human Immunodeficiency Virus Depression Sexually Transmitted Diseases

COMPLETED PHASE3

Effect of HIV/STD Risk Reduction Program on South African Adolescents

NCT00559403

HIV Infections Sexually Transmitted Disease

COMPLETED PHASE2/PHASE3

Implementing a Comprehensive Prevention of Mother-to-Child Transmission of HIV Program for South African Couples

NCT02085356

HIV Pregnancy

COMPLETED NA

Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings

NCT01735708

Pain Interference Depression Antiretroviral Adherence

COMPLETED NA

Brief HIV Prevention Counseling for STI Patients in South Africa

NCT01242501

Sexually Transmitted Infections

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Our Family Our Future Program is a preventive intervention program designed to prevent or reduce adolescent sexual risk behavior and to increase mental health resilience against depression onset among adolescents (13-15 years of age). The intervention takes a family approach and addresses HIV risk and depression in an integrated model. HIV and depression are the leading causes of global burden of disease in low and middle income countries. The intervention is being tested in South Africa, the country confronting the largest HIV epidemic in the world and because preliminary studies with South African families identified poor mental health and sexual risk behavior as priority areas for preventive intervention development and testing.

This study is a randomized pilot design, where 152 adolescents and parents will be randomly assigned to an intervention condition or a standard usual care condition and then offered the experimental intervention as on a wait-list. Families will be recruited and screened for eligibility based on systematic house-to-house recruitment in the community. Eligibility is based on dyadic eligibility and includes age criteria, consistent presence in the household, depressive symptoms that fall below clinically significant threshold criteria, and ability to provide informed consent and assent. Eligible families will be randomized and offered a preventive intervention program in a group format, led by program facilitators in a community setting. The intervention program consists of 3 sessions plus an individualized family meeting. In some modules parents/guardians/caregivers and adolescents will have content delivered together and in some modules parents/guardians/caregivers and adolescents will break out to adult-only or adolescent-only groups.

The overall objective of study is to assess the following study questions:

Question 1: Is this study feasible? Question 2: Is this intervention acceptable to the target population? Question 3: Is there preliminary evidence of hypothesized effects of the intervention, that the intervention will reduce or maintaining symptoms that fall below the clinically significant range for depression and reduce or delay actual or intended sexual risk behavior in adolescents?

The study takes a single blind, randomized pilot trial. The study takes a secondary prevention approach. The investigators collect three sets of data. First, the investigators assess feasibility by examining recruitment rates, attendance, completion, and drop-out rates, and fidelity. Second, the investigators assess acceptability by examining satisfaction data. Third, as a secondary aim, the investigators use pilot data to assess hypothesized intervention effects by examining outcomes at baseline, immediately post-intervention (2-4 weeks after the last intervention session is completed), and at four months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sexual Behavior Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Families are randomly allocated to a behavioral intervention arm (called Our Family Our Future) focusing on reducing sexual risk behavior in adolescents and reducing or maintaining symptoms that fall below the clinically significant range for depression. Arms will be allocated using urn randomization.

Group Type EXPERIMENTAL

Our Family Our Future

Intervention Type BEHAVIORAL

The Our Family Our Future Program is a family preventive intervention that uses resilience and prevention focused strategies to reduce sexual risk behaviors and build mental wellbeing among adolescents.

Control

Families are randomly allocated to the control arm (which receives standard usual care, and then offered the intervention after outcome assessments as a wait-list) using urn randomization.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Our Family Our Future

The Our Family Our Future Program is a family preventive intervention that uses resilience and prevention focused strategies to reduce sexual risk behaviors and build mental wellbeing among adolescents.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

PARENTS/GUARDIANS/CAREGIVERS

1. 18+ years
2. primary caregiver or the person responsible for childcare in the household on a day to day basis (as identified by the household);
3. when more than one primary caregiver exists in the household, one will be chosen at random;
4. lives in the household at least 4 days a week
5. sub clinical thresholds of depressive symptoms

1. 13-15 years;
2. concurs that the adult identified is their primary caregiver;
3. when more than one child in the family falls within the eligible age range, one child will be chosen at random;
4. lives in the household at least 4 days a week;
5. sub clinical thresholds of depressive symptoms

Exclusion Criteria

PARENTS/GUARDIANS/CAREGIVERS \& Adolescents

1. cognitive impairments that would not allow them to provide informed consent or assent;
2. if they participated in qualitative phases of the study
3. report no or low symptoms or clinically significant thresholds of depression -

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes