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Completed

NCT Number: NCT03858803

Improving the Reproductive Health of Families

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.

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Key information

Conditions

Reproductive Health Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Urogenital Diseases

Age range

13 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Janet S. St. Lawrence

Portland, Oregon, 97206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Families Matter 2

Behavioral

Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.

Other names: FM2

Living as a Safer Teen

Behavioral

Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.

Other names: LAST

Primary outcomes

  1. Changes in Frequency of Unprotected Intercourse (Youth)

    Time frame: 6 month

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

  2. 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.

  3. 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

  4. 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

  5. Change in Number of Sex Partners (Youth)

    Time frame: 6 months

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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Portland State University

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 1, 2019
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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