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

NCT02432352 | Completed Phase 1

• 1 other identifier: K01MH096646
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Behavior; Depression

Outcome Measures

Primary Outcomes (4)

• Change from baseline in sexual behavior or intended sexual behavior at 4 months post-intervention

  as measured through lifetime and past 3 month sexual acts, condom use, HIV and STI status, prior pregnancy

  assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention

• Change or maintenance of depressive symptoms at sub-clinical range from baseline to 4 months post-intervention measured by CES-D and CES-DC

  Self-reported depressive symptoms

  assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention

• 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

  acceptability will be assessed during the intervention, an expected average timeframe of 4 weeks

• Intervention feasibility measured by attendance, retention for outcome assessments, fidelity

  cceptability will be assessed during the intervention, an expected average timeframe of 4 weeks

Secondary Outcomes (20)

• Change in resilience from baseline to 4 months post-intervention as measured through CD-RISC

  assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention

• Change in depression impairment from baseline to 4 months post-intervention as measured through DISP and CPODMV

  assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention

• 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

  assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention

• Change in HIV knowledge from baseline to 4 months post-intervention as measured through the HIV Knowledge Questionnaire

  assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention

• Change in HIV stigma from baseline to 4 months post-intervention as measured through the HIV Knowledge Questionnaire

  assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Our Family Our Future

Control

NO INTERVENTION

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.

Interventions

Our Family Our Future 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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• PARENTS/GUARDIANS/CAREGIVERS
• + years
• primary caregiver or the person responsible for childcare in the household on a day to day basis (as identified by the household);
• when more than one primary caregiver exists in the household, one will be chosen at random;
• lives in the household at least 4 days a week
• sub clinical thresholds of depressive symptoms
• years;
• concurs that the adult identified is their primary caregiver;
• 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;
• sub clinical thresholds of depressive symptoms

You may not qualify if:

• PARENTS/GUARDIANS/CAREGIVERS \& Adolescents
• cognitive impairments that would not allow them to provide informed consent or assent;
• if they participated in qualitative phases of the study
• report no or low symptoms or clinically significant thresholds of depression -

Sponsors & Collaborators

• Brown University: lead
• University of Cape Town: collaborator

Study Sites (1)

Caroline Kuo

Cape Town, Western Cape, 780, South Africa

Location

Related Publications (5)

• 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.

  PMID: 26916841 RESULT

• 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.

  PMID: 30289374 RESULT

• Kuo C, Mathews C, LoVette A, Harrison A, Orchowski L, Pellowski JA, Atujuna M, Stein DJ, Brown LK. Perpetration of sexual aggression among adolescents in South Africa. J Adolesc. 2019 Apr;72:32-36. doi: 10.1016/j.adolescence.2019.02.002. Epub 2019 Feb 13.

  PMID: 30771665 RESULT

• Kuo C, LoVette A, Pellowski J, Harrison A, Mathews C, Operario D, Beardslee W, Stein DJ, Brown L. Resilience and psychosocial outcomes among South African adolescents affected by HIV. AIDS. 2019 Jun 1;33 Suppl 1(Suppl 1):S29-S34. doi: 10.1097/QAD.0000000000002177.

  PMID: 31397720 RESULT

• Kuo C, Mathews C, Giovenco D, Atujuna M, Beardslee W, Hoare J, Stein DJ, Brown LK. Acceptability, Feasibility, and Preliminary Efficacy of a Resilience-Oriented Family Intervention to Prevent Adolescent HIV and Depression: A Pilot Randomized Controlled Trial. AIDS Educ Prev. 2020 Feb;32(1):67-81. doi: 10.1521/aeap.2020.32.1.67.

  PMID: 32202920 RESULT

MeSH Terms

Conditions

Sexual Behavior; Depression

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 19, 2015
• First Posted: May 4, 2015
• Study Start: May 1, 2015
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

ZA (1)