Clinical trial NCT02432352: Our Family Our Future: Acceptability and Feasibility Study of a Family Prevention Program for HIV Risk and Depression
Official title: Our Family Our Future: Family Prevention of HIV Risk and Depression in HIV-endemic South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sexual Behavior
Depression
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: University of Cape Town
First posted: 2015-05-04
Enrollment: 152
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Change from baseline in sexual behavior or intended sexual behavior at 4 months post-intervention
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change or maintenance of depressive symptoms at sub-clinical range from baseline to 4 months post-intervention measured by CES-D and CES-DC
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Intervention acceptability - satisfaction with intervention content, delivery, length using the client satisfaction questionnaire and as measured on a likert scale response and as open-ended response options
timeFrame: acceptability will be assessed during the intervention, an expected average timeframe of 4 weeks
measure: Intervention feasibility measured by attendance, retention for outcome assessments, fidelity
timeFrame: cceptability will be assessed during the intervention, an expected average timeframe of 4 weeks
Secondary outcomes:
measure: Change in resilience from baseline to 4 months post-intervention as measured through CD-RISC
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in depression impairment from baseline to 4 months post-intervention as measured through DISP and CPODMV
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in perceived HIV risk susceptibility from baseline to 4 months post-intervention using a ranking derived from a 0-100 and as measured on a likert scale response
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in HIV knowledge from baseline to 4 months post-intervention as measured through the HIV Knowledge Questionnaire
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in HIV stigma from baseline to 4 months post-intervention as measured through the HIV Knowledge Questionnaire
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in norms and attitudes about sex from baseline to 4 months post-intervention as measured on a likert scale response
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in norms and attitudes about condoms from baseline to 4 months post-intervention as measured through the condom attitudes scale and likert response questions
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in sexual behavior self-efficacy from baseline to 4 months post-interventionusing a ranking derived from a 0-100 and as measured on a likert scale response
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in anxiety from baseline to 4 months post-interventionas measured through BAI and RCMAS
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in psychological distress from baseline to 4 months post-intervention as measured through K6 and SDQ
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in trauma symptoms from baseline to 4 months post-intervention as measured through PCL and NSESSS
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in substance use from baseline to 4 months post-intervention as measured through AUDIT and DUDIT
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in hope from baseline to 4 months post-intervention as measured through BHS
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in social support from baseline to 4 months post-intervention as measured through MSPSS
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in family relationship from baseline to 4 months post-intervention as measured through Family Relationship Scale
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in family communication from baseline to 4 months post-intervention as measured through the Parent-adolescent Communication Scale
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in family communication from baseline to 4 months post-intervention as measured through the Parent-adolescent Sex Communication Scale
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in family relationship from baseline to 4 months post-intervention as measured through the Inventory of Parent-peer Attachment
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in parenting from baseline to 4 months post-interventionas measured through the Parental Monitoring Questionnaire
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
measure: Change in parenting from baseline to 4 months post-intervention as measured through the Parenting Scale
timeFrame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Caroline Kuo
state: Western Cape
Study officials:
References:
citation: Kuo C, Atujuna M, Mathews C, Stein DJ, Hoare J, Beardslee W, Operario D, Cluver L, K Brown L. Developing family interventions for adolescent HIV prevention in South Africa. AIDS Care. 2016;28 Suppl 1(sup1):106-10. doi: 10.1080/09540121.2016.1146396. Epub 2016 Feb 26.
citation: Kuo C, LoVette A, Stein DJ, Cluver LD, Brown LK, Atujuna M, Gladstone TRG, Martin J, Beardslee W. Building resilient families: Developing family interventions for preventing adolescent depression and HIV in low resource settings. Transcult Psychiatry. 2019 Feb;56(1):187-212. doi: 10.1177/1363461518799510. Epub 2018 Oct 5.