MedPath

Improving the Reproductive Health of Families

Not Applicable
Conditions
Reproductive Health
Interventions
Behavioral: Families Matter 2
Behavioral: Living as a Safer Teen
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
UNKNOWN
Sex
All
Target Recruitment
1000
Inclusion Criteria
  • Adolescent 13-18 in or near Gaborone Botswana and parent/guardian
Exclusion Criteria
  • None

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
FM2 first, LAST delayedFamilies Matter 2Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
FM2 and LAST simultaneousFamilies Matter 2Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
FM2 and LAST simultaneousLiving as a Safer TeenParents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Comparison armFamilies Matter 2Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
FM2 first, LAST delayedLiving as a Safer TeenParent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Comparison armLiving as a Safer TeenComparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Primary Outcome Measures
NameTimeMethod
Changes in frequency of unprotected intercourse (youth and parents)one year

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

Changes in Reproductive Health Knowledge Test scores (youth)one year

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)one year

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

Change in Attitudes toward Transactional Sex Scale (youth)one year

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

Change in number of sex partners (youth and parent)one year

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

Changes on Family Communication Scale (parents and youth)One year

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

Changes in scores on the Condom Attitudes Scale (youth)One year

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)One year

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

Changes on Parental Responsiveness Scale (parent and youth)One year

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

Changes in Parent Use of Positive Reinforcement Scale (parent and youth)One year

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

Changes in Parental Monitoring Scale (parent and youth)One year

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Janet S. St. Lawrence

🇺🇸

Portland, Oregon, United States

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