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Clinical Trials/NCT03858803
NCT03858803
Completed
N/A

Improving the Reproductive Health of Families

Portland State University1 site in 1 country945 target enrollmentApril 22, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Reproductive Health
Sponsor
Portland State University
Enrollment
945
Locations
1
Primary Endpoint
Changes in Parent Use of Positive Reinforcement Scale (Youth)
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

This research will assess the effectiveness of a parent- and an adolescent- intervention in lowering risk of STIs, HIV, and unintended pregnancies among Batswana youth.

Detailed Description

Youth in Botswana face extraordinary challenges as they transition through adolescence. High rates of teen pregnancy force girls to drop out of school after which few resume their education. Sexually transmitted infections (STIs) are prevalent and the country has the 3rd highest Human Immunodeficiency Virus (HIV) prevalence in the world, with incidence increasing rapidly among adolescents 15-19, peaking at 40.2% HIV seroprevalence at ages 30-34. Traditional methods for sex education through village initiation schools are no longer available and parents are not comfortable with discussions addressing reproductive health within the family. As a result, adolescents have no conduit to educate them about healthy sexual development. This study will recruit 456 families, ½ with a male and ½ with a female adolescent. Families will be randomized to one of three intervention arms. Parents will participate in Families Matter 2! (FM2) and adolescents in Living as a Safer Teen (LAST), both evidence-based interventions that were adapted and pilot tested in Botswana during an earlier R34 award. In Arm 1, the parent will participate in FM2 immediately and the youth will participate in LAST six months later. In Arm 2, both the parent and youth will participant in their respective interventions simultaneously. In Arm 3, the comparison condition, participants will be offered the interventions immediately after the final assessment. Each adolescent and parent will complete assessments in English or Setswana at baseline, post-intervention, and 6- and 12-month follow-ups. Results from a pilot trial of the adapted interventions suggest that these interventions may result in improved family communications, child management skills, knowledge of sexual development, more favorable attitudes toward contraception, less tolerance for intergenerational transactional sex, greater rejection of gender violence, and lower rates of sexual risk behavior by both parents and adolescents. It is further anticipated that youths who are abstinent upon entering the intervention will delay sexual debut to a greater extent than youth in the comparison arm. This proposed study addresses the highest priority in Botswana's current national strategic plan: preventing early pregnancy, STIs and HIV in adolescents. If the proposed randomized controlled trial (RCT) provides strong evidence of effectiveness, the investigators will work with the Ministries of Education, Health, Youth \& Culture and the Office of the President to disseminate the intervention throughout Botswana.

Registry
clinicaltrials.gov
Start Date
April 22, 2019
End Date
January 30, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adolescent 13-18 in or near Gaborone Botswana and parent/guardian

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes in Parent Use of Positive Reinforcement Scale (Youth)

Time Frame: 6 month

Total score range 0-12, No Subscales, Higher score reflect reports of more frequent use of positive reinforcement by parents

Changes in Frequency of Unprotected Intercourse (Youth)

Time Frame: 6 month

Self-reported frequency of unprotected intercourse occasions in past 3 months.

Changes on Family Communication Scale (Youth)

Time Frame: 6 month

Total scale range 0-52, No subscales, Higher scores reflect more frequent communication between parent and child frequency

Changes in Reproductive Health Knowledge Test Scores (Youth)

Time Frame: 6 month

Measure of knowledge about prevention of STIs, HIV, and pregnancy. Total score range 0-26. No subscales. Higher scores reflect more accurate knowledge.

Changes in Condom Barriers Scale(Youth)

Time Frame: 6 month

Total score range 0 - 140; Higher scores reflect greater perceived barriers to condom use. No subscales

Change in Attitudes Toward Transactional Sex Scale (Youth)

Time Frame: 6 month

Total score range 0 - 120, No subscales, Higher scores reflect more acceptance of transactional sex

Change in Number of Sex Partners (Youth)

Time Frame: 6 months

Change in self-reported numbers of sex partners in past two months

Changes on Parental Responsiveness Scale (Youth)

Time Frame: 6 month

Total scale score range 0-11, No subscales, Higher scores reflect reports of greater parental responsiveness

Changes in Scores on the Condom Attitudes Scale (Youth)

Time Frame: 6 month

Total scale score range 0-144, No subscales, Higher scores reflect more positive attitudes toward condom use

Changes in Scores on Self Efficacy Beliefs Scale (Youth)

Time Frame: 6 month

Total scale score range 0-160, No subscales, Higher scores reflect endorsement of greater self efficacy beliefs

Changes in Parental Monitoring Scale (Youth)

Time Frame: 6 month

Total scale score range 0-16, No subscales, Higher scores reflect report of greater parental monitoring

Study Sites (1)

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