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.

Study Overview

• Status: Recruiting
• Conditions: Reproductive Health
• Intervention / Treatment: Behavioral: Families Matter 2; Behavioral: Living as a Safer Teen

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janet S St. Lawrence; Phone Number: 5034447507; Email: jstla2@pdx.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97206
      • Recruiting
      • Janet S. St. Lawrence
      • Contact: Janet S St. Lawrence, Ph.D.; Phone Number: 503-444-7507; Email: jstla2@pdx.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FM2 first, LAST delayed; Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months	Behavioral: Families Matter 2; Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.; Other Names: FM2; Behavioral: Living as a Safer Teen; Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.; Other Names: LAST
Active Comparator: FM2 and LAST simultaneous; Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.	Behavioral: Families Matter 2; Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.; Other Names: FM2; Behavioral: Living as a Safer Teen; Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.; Other Names: LAST
Active Comparator: Comparison arm; Comparison 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.	Behavioral: Families Matter 2; Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.; Other Names: FM2; Behavioral: Living as a Safer Teen; Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.; Other Names: LAST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in frequency of unprotected intercourse (youth and parents)	Self-reported frequency of unprotected intercourse occasions in past 3 months.	one year
Changes in Reproductive Health Knowledge Test scores (youth)	Measure of knowledge about prevention of STIs, HIV, and pregnancy. Total score range 0-26. No subscales. Higher scores reflect more accurate knowledge.	one year
Changes in Condom Barriers Scale(youth)	Total score range 0 - 140; Higher scores reflect fewer perceived barriers to condom use. No subscales	one year
Change in Attitudes toward Transactional Sex Scale (youth)	Total score range 0 - 120, No subscales, Higher scores reflect less acceptance of transactional sex	one year
Change in number of sex partners (youth and parent)	Change in self-reported numbers of sex partners in past three months	one year
Changes on Family Communication Scale (parents and youth)	Total scale range 0-52, No subscales, Higher scores reflect more frequent communication between parent and child frequency	One year
Changes in scores on the Condom Attitudes Scale (youth)	Total scale score range 0-144, No subscales, Higher scores reflect more positive attitudes toward condom use	One year
Changes in scores on Self Efficacy Beliefs Scale (youth)	Total scale score range 0-160, No subscales, Higher scores reflect endorsement of greater self efficacy beliefs	One year
Changes on Parental Responsiveness Scale (parent and youth)	Total scale score range 0-11, No subscales, Higher scores reflect reports of greater parental responsiveness	One year
Changes in Parent Use of Positive Reinforcement Scale (parent and youth)	Total score range 0-12, No Subscales, Higher score reflect reports of more frequent use of positive reinforcement by parents	One year
Changes in Parental Monitoring Scale (parent and youth)	Total scale score range 0-16, No subscales, Higher scores reflect report of greater parental monitoring	One year

Collaborators and Investigators

• Sponsor: Portland State University
• Investigators: Principal Investigator: Janet S St. Lawrence, Ph.D., Portland State University; Study Director: Esther S Seloilwe, Ph.D., University of Botswana

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Adolescents; HIV; STI; Unplanned pregnancy; Reproductive health of families
• Other Study ID Numbers: Botswana Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized data will be made available upon study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No