Reproductive HealthNCT03858803
Improving the Reproductive Health of Families
A study testing Families Matter 2 and Living as a Safer Teen in people with Reproductive Health, run by Portland State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Reproductive Health
- What is being tested?
- Families Matter 2 and Living as a Safer Teen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 945 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2019to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adolescent 13-18 in or near Gaborone Botswana and parent/guardian
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Reproductive Health
- Being tested
- Families Matter 2, Living as a Safer Teen
- Keywords
- HIV, STI, Unplanned pregnancy, Reproductive health of families, Adolescents
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Families Matter 2Behavioural
Also called FM2
Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer TeenBehavioural
Also called LAST
Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| FM2 first, LAST delayed | Active comparator | Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months Receives: 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. Receives: 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. Receives: Behavioral: Families Matter 2; Behavioral: Living as a Safer Teen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Frequency of Unprotected Intercourse (Youth)
Self-reported frequency of unprotected intercourse occasions in past 3 months.
Measured: 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.
Measured: 6 month
Changes in Condom Barriers Scale(Youth)
Total score range 0 - 140; Higher scores reflect greater perceived barriers to condom use. No subscales
Measured: 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
Measured: 6 month
Change in Number of Sex Partners (Youth)
Change in self-reported numbers of sex partners in past two months
Measured: 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
Measured: 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
Measured: 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
Measured: 6 month
Changes on Parental Responsiveness Scale (Youth)
Total scale score range 0-11, No subscales, Higher scores reflect reports of greater parental responsiveness
Measured: 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
Measured: 6 month
Changes in Parental Monitoring Scale (Youth)
Total scale score range 0-16, No subscales, Higher scores reflect report of greater parental monitoring
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start22 Apr 2019
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Reproductive HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 945 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portland State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet S St. Lawrence, Ph.D., Principal investigator, Portland State UniversityEsther S Seloilwe, Ph.D., Study director, University of Botswana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858803
- Sponsor's protocol ID
- Botswana Study
- Status last verified
- Jul 2025
- First submitted
- 21 Feb 2019
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data will be made available upon study completion.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Reproductive Health of Families
- ClinicalTrials.gov ID
- NCT03858803
- Acronym / sponsor ID
- Botswana Study
- Conditions
- Reproductive Health
- Keywords
- HIV, STI, Unplanned pregnancy, Reproductive health of families, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 945 participants (actual)
- Lead sponsor
- Portland State UniversityUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Posted 17 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| FM2 first, LAST delayed | Active comparator | Behavioral: Families Matter 2, Behavioral: Living as a Safer TeenParent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months |
| FM2 and LAST simultaneous | Active comparator | Behavioral: Families Matter 2, Behavioral: Living 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 arm | Active comparator | Behavioral: Families Matter 2, Behavioral: Living 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. |
Who may qualify
- Ages
- 13 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adolescent 13-18 in or near Gaborone Botswana and parent/guardian
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Families Matter 2Also: FM2Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management. | Behavioural | Comparison arm, FM2 and LAST simultaneous, FM2 first, LAST delayed |
| Living as a Safer TeenAlso: LASTPrevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy. | Behavioural | Comparison arm, FM2 and LAST simultaneous, FM2 first, LAST delayed |
Primary outcome
Changes in Frequency of Unprotected Intercourse (Youth)
Time frame: 6 month
Self-reported frequency of unprotected intercourse occasions in past 3 months.
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.
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
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
Change in Number of Sex Partners (Youth)
Time frame: 6 months
Change in self-reported numbers of sex partners in past two months
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Anonymized data will be made available upon study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet S St. Lawrence, Ph.D. principal investigator
Portland State University
Esther S Seloilwe, Ph.D. study director
University of Botswana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Families Matter 2 and Living as a Safer Teen in people with Reproductive Health, run by Portland State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Frequency of Unprotected Intercourse (Youth) (time frame: 6 month). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.