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CompletedNCT03858803Updated Aug 17, 2025Results posted

Improving the Reproductive Health of Families

An interventional study of Families Matter 2 and Living as a Safer Teen in Reproductive Health, sponsored by Portland State University. Completed at 1 site in United States. Open to participants aged 13 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by Portland State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
945
Allocation
Randomized
Ages
13 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Reproductive Health

Keywords

  • HIV
  • STI
  • Unplanned pregnancy
  • Reproductive health of families
  • Adolescents
03

In context

Sexually Transmitted Diseases

523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.

This study's enrollment of 945 is above the median of 449 across 425 interventional studies indexed under Sexually Transmitted Diseases.

Browse Sexually Transmitted Diseases studies →

Lead sponsor

Portland State University is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
945 participants (actual)

Study arms

  • 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 · Behavioral: Living as a Safer Teen

  • 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 · Behavioral: Living as a Safer Teen

  • 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 · Behavioral: Living as a Safer Teen

Interventions

  • BehavioralFamilies Matter 2

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

    Also known as: FM2

  • BehavioralLiving as a Safer Teen

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

    Also known as: LAST

06

What researchers measure

Primary outcomes

  1. Changes in Frequency of Unprotected Intercourse (Youth)

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

    Time frame: 6 month

  2. 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.

    Time frame: 6 month

  3. Changes in Condom Barriers Scale(Youth)

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

    Time frame: 6 month

  4. Change in Attitudes Toward Transactional Sex Scale (Youth)

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

    Time frame: 6 month

  5. Change in Number of Sex Partners (Youth)

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

    Time frame: 6 months

  6. Changes on Family Communication Scale (Youth)

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

    Time frame: 6 month

  7. 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

    Time frame: 6 month

  8. 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

    Time frame: 6 month

  9. Changes on Parental Responsiveness Scale (Youth)

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

    Time frame: 6 month

  10. 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

    Time frame: 6 month

  11. Changes in Parental Monitoring Scale (Youth)

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

    Time frame: 6 month

07

Results

Posted Aug 17, 2025
Limitations and caveats
One year follow-up for intervention outcomes was planned; however, the COVID pandemic and associated restrictions interrupted data collection.

Participant flow

Participant flow — Overall Study
MilestoneFM2 First, LAST Delayed - YouthFM2 First, LAST Delayed - ParentsFM2 and LAST Simultaneous - YouthFM2 and LAST Simultaneous - ParentsComparison Arm - YouthComparison Arm - Parents
Started161161158160153152
Post161161158160153152
Completed148151153155149149
Not completed13105543

Outcome measures

PrimaryChanges in Frequency of Unprotected Intercourse (Youth)

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

Time frame:
6 month
Reported as:
Mean · number of occassions
Changes in Frequency of Unprotected Intercourse (Youth)
number of occassionsFM2 First, LAST DelayedFM2 and LAST SimultaneousComparison Arm
Changes in Frequency of Unprotected Intercourse (Youth)1.42 ± 3.091.16 ± 1.781.38 ± 2.93
Statistical analysis
  • FM2 First, LAST Delayed vs FM2 and LAST Simultaneous vs Comparison Arm · MANOVA · p = <.05
PrimaryChanges 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.

Time frame:
6 month
Reported as:
Mean · score on a scale
Changes in Reproductive Health Knowledge Test Scores (Youth)
score on a scaleFM2 First, LAST DelayedFM2 and LAST SimultaneousComparison Arm
Changes in Reproductive Health Knowledge Test Scores (Youth)12.79 ± 6.3214.66 ± 6.9011.37 ± 5.99
Statistical analysis
  • FM2 First, LAST Delayed vs FM2 and LAST Simultaneous vs Comparison Arm · MANOVA · p = <.05
PrimaryChanges in Condom Barriers Scale(Youth)

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

Time frame:
6 month
Reported as:
Mean · score on a scale
Changes in Condom Barriers Scale(Youth)
score on a scaleFM2 First, LAST DelayedFM2 and LAST SimultaneousComparison Arm
Changes in Condom Barriers Scale(Youth)63.67 ± 20.0857.73 ± 22.3066.37 ± 19.12
Statistical analysis
  • FM2 First, LAST Delayed vs FM2 and LAST Simultaneous vs Comparison Arm · MANOVA · p = <.05
PrimaryChange in Attitudes Toward Transactional Sex Scale (Youth)

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

Time frame:
6 month
Reported as:
Mean · score on a scale
Change in Attitudes Toward Transactional Sex Scale (Youth)
score on a scaleFM2 First, LAST DelayedFM2 and LAST SimultaneousComparison Arm
Change in Attitudes Toward Transactional Sex Scale (Youth)19.67 ± 12.9320.44 ± 13.4923.18 ± 14.70
Statistical analysis
  • FM2 First, LAST Delayed vs FM2 and LAST Simultaneous vs Comparison Arm · MANOVA · p = <.05
PrimaryChange in Number of Sex Partners (Youth)

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

Time frame:
6 months
Reported as:
Mean · number of sex partners
Change in Number of Sex Partners (Youth)
number of sex partnersFM2 First, LAST DelayedFM2 and LAST SimultaneousComparison Arm
Change in Number of Sex Partners (Youth)0.91 ± 0.801.12 ± 2.092.14 ± 3.59
Statistical analysis
  • FM2 First, LAST Delayed vs FM2 and LAST Simultaneous vs Comparison Arm · MANOVA · p = <.05
PrimaryChanges on Family Communication Scale (Youth)

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

Time frame:
6 month
Reported as:
Mean · score on a scale
Changes on Family Communication Scale (Youth)
score on a scaleFM2 First, LAST DelayedFM2 and LAST SimultaneousComparison Arm
Changes on Family Communication Scale (Youth)23.89 ± 14.5824.33 ± 14.5320.73 ± 13.82
Statistical analysis
  • FM2 First, LAST Delayed vs FM2 and LAST Simultaneous vs Comparison Arm · MANOVA · p = <.05
PrimaryChanges 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

Time frame:
6 month
Reported as:
Mean · score on a scale
Changes in Scores on the Condom Attitudes Scale (Youth)
score on a scaleFM2 First, LAST DelayedFM2 and LAST SimultaneousComparison Arm
Changes in Scores on the Condom Attitudes Scale (Youth)94.40 ± 26.5096.65 ± 31.0092.09 ± 26.85
Statistical analysis
  • FM2 First, LAST Delayed vs FM2 and LAST Simultaneous vs Comparison Arm · MANOVA · p = <.05
PrimaryChanges 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

Time frame:
6 month
Reported as:
Mean · score on a scale
Changes in Scores on Self Efficacy Beliefs Scale (Youth)
score on a scaleFM2 First, LAST DelayedFM2 and LAST SimultaneousComparison Arm
Changes in Scores on Self Efficacy Beliefs Scale (Youth)58.99 ± 47.2971.82 ± 52.6867.83 ± 52.05
Statistical analysis
  • FM2 First, LAST Delayed vs FM2 and LAST Simultaneous vs Comparison Arm · MANOVA · p = <.05
PrimaryChanges on Parental Responsiveness Scale (Youth)

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

Time frame:
6 month
Reported as:
Mean · score on a scale
Changes on Parental Responsiveness Scale (Youth)
score on a scaleFM2 First, LAST DelayedFM2 and LAST SimultaneousComparison Arm
Changes on Parental Responsiveness Scale (Youth)6.06 ± 3.726.41 ± 3.595.23 ± 3.70
Statistical analysis
  • FM2 First, LAST Delayed vs FM2 and LAST Simultaneous vs Comparison Arm · MANOVA · p = <.05
PrimaryChanges 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

Time frame:
6 month
Reported as:
Mean · score on a scale
Changes in Parent Use of Positive Reinforcement Scale (Youth)
score on a scaleFM2 First, LAST DelayedFM2 and LAST SimultaneousComparison Arm
Changes in Parent Use of Positive Reinforcement Scale (Youth)5.95 ± 3.115.92 ± 3.235.78 ± 3.26
Statistical analysis
  • FM2 First, LAST Delayed vs FM2 and LAST Simultaneous vs Comparison Arm · MANOVA · p = <.05
PrimaryChanges in Parental Monitoring Scale (Youth)

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

Time frame:
6 month
Reported as:
Mean · score on a scale
Changes in Parental Monitoring Scale (Youth)
score on a scaleFM2 First, LAST DelayedFM2 and LAST SimultaneousComparison Arm
Changes in Parental Monitoring Scale (Youth)9.67 ± 3.929.82 ± 4.4310.03 ± 3.93
Statistical analysis
  • FM2 First, LAST Delayed vs FM2 and LAST Simultaneous vs Comparison Arm · MANOVA · p = <.05

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
FM2 First, LAST Delayed - Youth0/161 (0%)0/161 (0%)0/161 (0%)
FM2 and LAST Simultaneous - Youth0/158 (0%)0/158 (0%)0/158 (0%)
Comparison Arm - Youth0/153 (0%)0/153 (0%)0/153 (0%)
FM2 First, LAST Delayed - Parent0/161 (0%)0/161 (0%)0/161 (0%)
FM2 and LAST Simultaneous - Parent0/160 (0%)0/160 (0%)0/160 (0%)
Comparison Arm - Parent0/152 (0%)0/152 (0%)0/152 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)FM2 First, LAST Delayed - YouthFM2 and LAST Simultaneous - YouthComparison Arm - YouthFM2 First, LAST Delayed - ParentsFM2 and LAST Simultaneous - ParentsComparison Arm - ParentsTotal
<=18 years161158153032477
Between 18 and 65 years000154153143450
>=65 years00074718
Age, Continuous
Age, Continuous(years)FM2 First, LAST Delayed - YouthFM2 and LAST Simultaneous - YouthComparison Arm - YouthFM2 First, LAST Delayed - ParentsFM2 and LAST Simultaneous - ParentsComparison Arm - ParentsTotal
Mean15.1 ± 1.715.26 ± 1.515.00 ± 1.741.95 ± 9.1238.56 ± 9.3441.03 ± 9.7927.83 ± 12.74
Sex: Female, Male
Sex: Female, Male(Participants)FM2 First, LAST Delayed - YouthFM2 and LAST Simultaneous - YouthComparison Arm - YouthFM2 First, LAST Delayed - ParentsFM2 and LAST Simultaneous - ParentsComparison Arm - ParentsTotal
Female958684142143139689
Male667269191713256
Race (NIH/OMB)
Race (NIH/OMB)(Participants)FM2 First, LAST Delayed - YouthFM2 and LAST Simultaneous - YouthComparison Arm - YouthFM2 First, LAST Delayed - ParentsFM2 and LAST Simultaneous - ParentsComparison Arm - ParentsTotal
American Indian or Alaska Native0000000
Asian0000000
Native Hawaiian or Other Pacific Islander0000000
Black or African American161158153161160152945
White0000000
More than one race0000000
Unknown or Not Reported0000000
Region of Enrollment
Region of Enrollment(participants)FM2 First, LAST Delayed - YouthFM2 and LAST Simultaneous - YouthComparison Arm - YouthFM2 First, LAST Delayed - ParentsFM2 and LAST Simultaneous - ParentsComparison Arm - ParentsTotal
Botswana161158153161160152945
Parental Monitoring
Parental Monitoring(units on a scale)FM2 First, LAST Delayed - YouthFM2 and LAST Simultaneous - YouthComparison Arm - YouthFM2 First, LAST Delayed - ParentsFM2 and LAST Simultaneous - ParentsComparison Arm - ParentsTotal
Mean9.51 ± 3.7510.03 ± 4.259.62 ± 4.248.35 ± 4.228.38 ± 4.488.20 ± 4.639.02 ± .72
08

Study locations

1 site
  • Janet S. St. Lawrence
    Portland, Oregon 97206, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Anonymized data will be made available upon study completion.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03858803
Lead sponsor
Portland State University
Responsible party
Sponsor
First posted
Mar 1, 2019
Start date
Apr 22, 2019
Primary completion
Jan 30, 2024
Completion
Jan 30, 2024
Results posted
Aug 17, 2025
Last update
Aug 17, 2025

Study contacts

Janet S St. Lawrence, Ph.D.
principal investigator · Portland State University
Esther S Seloilwe, Ph.D.
study director · University of Botswana

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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