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

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 124 families will be randomly assigned to an
intervention condition or a wait-list control condition. 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 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, 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 three months.

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 -