Improving the Reproductive Health of Families

Not Applicable

Completed

Conditions: Reproductive Health

Registration Number: NCT03858803

Lead Sponsor: Portland State University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 945

Inclusion Criteria

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

Exclusion Criteria

None

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Changes in Parent Use of Positive Reinforcement Scale (Youth)	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)	6 month	Self-reported frequency of unprotected intercourse occasions in past 3 months.
Changes on Family Communication Scale (Youth)	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)	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)	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)	6 month	Total score range 0 - 120, No subscales, Higher scores reflect more acceptance of transactional sex
Change in Number of Sex Partners (Youth)	6 months	Change in self-reported numbers of sex partners in past two months
Changes on Parental Responsiveness Scale (Youth)	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)	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)	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)	6 month	Total scale score range 0-16, No subscales, Higher scores reflect report of greater parental monitoring

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Janet S. St. Lawrence
🇺🇸
Portland, Oregon, United States
Janet S. St. Lawrence
🇺🇸Portland, Oregon, United States
Janet S St. Lawrence, Ph.D.
Contact
503-444-7507
jstla2@pdx.edu