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

Brown University

Status and phase: Completed; Phase 1

Conditions: Sexual Behavior; Depression

Treatments: Behavioral: Our Family Our Future

Study type: Interventional

Funder types: Other

Identifiers

NCT02432352

K01MH096646

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 146 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Adolescent inclusion criteria are:

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 -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Our Family Our Future

Control

No Intervention group

Description:

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.