Improving the Reproductive Health of Families

NCT03858803 | Completed Results

• 1 other identifier: Botswana Study
• Study Type: interventional
• Target: 945
• Locations: 1 country
• Sites: 1

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.

Conditions

Reproductive Health

Keywords

HIV; STI; Unplanned pregnancy; Reproductive health of families; Adolescents

Outcome Measures

Primary Outcomes (11)

• Changes in Frequency of Unprotected Intercourse (Youth)

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

  6 month

• 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.

  6 month

• Changes in Condom Barriers Scale(Youth)

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

  6 month

• Change in Attitudes Toward Transactional Sex Scale (Youth)

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

  6 month

• Change in Number of Sex Partners (Youth)

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

  6 months

• Changes on Family Communication Scale (Youth)

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

  6 month

• 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

  6 month

• 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

  6 month

• Changes on Parental Responsiveness Scale (Youth)

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

  6 month

• Changes in Parent Use of Positive Reinforcement Scale (Youth)

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

  6 month

• Changes in Parental Monitoring Scale (Youth)

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

  6 month

Study Arms (3)

FM2 first, LAST delayed

ACTIVE COMPARATOR

Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months

Behavioral: Families Matter 2; Behavioral: Living as a Safer Teen

FM2 and LAST simultaneous

ACTIVE COMPARATOR

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; Behavioral: Living as a Safer Teen

Comparison arm

ACTIVE COMPARATOR

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; Behavioral: Living as a Safer Teen

Interventions

Families Matter 2 BEHAVIORAL

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

Also known as: FM2

Comparison arm; FM2 and LAST simultaneous; FM2 first, LAST delayed

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.

Also known as: LAST

Comparison arm; FM2 and LAST simultaneous; FM2 first, LAST delayed

Eligibility Criteria

• Age: 13 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Portland State University: lead

Study Sites (1)

Janet S. St. Lawrence

Portland, Oregon, 97206, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

One year follow-up for intervention outcomes was planned; however, the COVID pandemic and associated restrictions interrupted data collection.

Results Point of Contact

• Title: Dr. Janet S. St. Lawrence
• Organization: Portland State University

janetsstlawrence@gmail.com

971-978-7801

Study Officials

• Janet S St. Lawrence, Ph.D.

  Portland State University

  PRINCIPAL INVESTIGATOR

• Esther S Seloilwe, Ph.D.

  University of Botswana

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random assignment to one of three experimental arms: Arm 1: Parents complete intervention immediately, adolescents complete intervention 6 month later Arm 2: Both parents and adolescents participate in intervention simultaneously Arm 3: Comparison condition in which both parents and adolescents are offered their respective interventions after the final assessment

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 1, 2019
• Study Start: April 22, 2019
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)