Reproductive Health
Conditions
Keywords
HIV, STI, Unplanned pregnancy, Reproductive health of families, Adolescents
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.
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.
Interventions
BEHAVIORALFamilies Matter 2
Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
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.
Sponsors
Portland State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
13 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Adolescent 13-18 in or near Gaborone Botswana and parent/guardian
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Frequency of Unprotected Intercourse (Youth) | 6 month | Self-reported frequency of unprotected intercourse occasions in past 3 months. |
| Changes in Reproductive Health Knowledge Test Scores (Youth) | 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) | 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) | 6 month | Total score range 0 - 120, No subscales, Higher scores reflect more acceptance of transactional sex |
| Change in Number of Sex Partners (Youth) | 6 months | Change in self-reported numbers of sex partners in past two months |
| Changes on Family Communication Scale (Youth) | 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) | 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) | 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) | 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) | 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) | 6 month | Total scale score range 0-16, No subscales, Higher scores reflect report of greater parental monitoring |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FM2 First, LAST Delayed - Youth Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
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. | 161 |
| FM2 and LAST Simultaneous - Youth Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
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. | 158 |
| Comparison Arm - Youth 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.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
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. | 153 |
| FM2 First, LAST Delayed - Parents Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
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. | 161 |
| FM2 and LAST Simultaneous - Parents Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
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. | 160 |
| Comparison Arm - Parents 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. | 152 |
| Total | 945 |
Baseline characteristics
| Characteristic | FM2 and LAST Simultaneous - Youth | Comparison Arm - Youth | FM2 First, LAST Delayed - Parents | FM2 First, LAST Delayed - Youth | FM2 and LAST Simultaneous - Parents | Comparison Arm - Parents | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 158 Participants | 153 Participants | 0 Participants | 161 Participants | 3 Participants | 2 Participants | 477 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 7 Participants | 0 Participants | 4 Participants | 7 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 154 Participants | 0 Participants | 153 Participants | 143 Participants | 450 Participants |
| Age, Continuous | 15.26 years STANDARD_DEVIATION 1.5 | 15.00 years STANDARD_DEVIATION 1.7 | 41.95 years STANDARD_DEVIATION 9.12 | 15.1 years STANDARD_DEVIATION 1.7 | 38.56 years STANDARD_DEVIATION 9.34 | 41.03 years STANDARD_DEVIATION 9.79 | 27.83 years STANDARD_DEVIATION 12.74 |
| Parental Monitoring | 10.03 units on a scale STANDARD_DEVIATION 4.25 | 9.62 units on a scale STANDARD_DEVIATION 4.24 | 8.35 units on a scale STANDARD_DEVIATION 4.22 | 9.51 units on a scale STANDARD_DEVIATION 3.75 | 8.38 units on a scale STANDARD_DEVIATION 4.48 | 8.20 units on a scale STANDARD_DEVIATION 4.63 | 9.02 units on a scale STANDARD_DEVIATION 0.72 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 158 Participants | 153 Participants | 161 Participants | 161 Participants | 160 Participants | 152 Participants | 945 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Botswana | 158 participants | 153 participants | 161 participants | 161 participants | 160 participants | 152 participants | 945 participants |
| Sex: Female, Male Female | 86 Participants | 84 Participants | 142 Participants | 95 Participants | 143 Participants | 139 Participants | 689 Participants |
| Sex: Female, Male Male | 72 Participants | 69 Participants | 19 Participants | 66 Participants | 17 Participants | 13 Participants | 256 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 161 | 0 / 158 | 0 / 153 | 0 / 161 | 0 / 160 | 0 / 152 |
| other Total, other adverse events | 0 / 161 | 0 / 158 | 0 / 153 | 0 / 161 | 0 / 160 | 0 / 152 |
| serious Total, serious adverse events | 0 / 161 | 0 / 158 | 0 / 153 | 0 / 161 | 0 / 160 | 0 / 152 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FM2 First, LAST Delayed | Change in Attitudes Toward Transactional Sex Scale (Youth) | 19.67 score on a scale | Standard Deviation 12.93 |
| FM2 and LAST Simultaneous | Change in Attitudes Toward Transactional Sex Scale (Youth) | 20.44 score on a scale | Standard Deviation 13.49 |
| Comparison Arm | Change in Attitudes Toward Transactional Sex Scale (Youth) | 23.18 score on a scale | Standard Deviation 14.7 |
p-value: <0.05MANOVA
Primary
Change in Number of Sex Partners (Youth)
Change in self-reported numbers of sex partners in past two months
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FM2 First, LAST Delayed | Change in Number of Sex Partners (Youth) | 0.91 number of sex partners | Standard Deviation 0.8 |
| FM2 and LAST Simultaneous | Change in Number of Sex Partners (Youth) | 1.12 number of sex partners | Standard Deviation 2.09 |
| Comparison Arm | Change in Number of Sex Partners (Youth) | 2.14 number of sex partners | Standard Deviation 3.59 |
p-value: <0.05MANOVA
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FM2 First, LAST Delayed | Changes in Condom Barriers Scale(Youth) | 63.67 score on a scale | Standard Deviation 20.08 |
| FM2 and LAST Simultaneous | Changes in Condom Barriers Scale(Youth) | 57.73 score on a scale | Standard Deviation 22.3 |
| Comparison Arm | Changes in Condom Barriers Scale(Youth) | 66.37 score on a scale | Standard Deviation 19.12 |
p-value: <0.05MANOVA
Primary
Changes in Frequency of Unprotected Intercourse (Youth)
Self-reported frequency of unprotected intercourse occasions in past 3 months.
Time frame: 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FM2 First, LAST Delayed | Changes in Frequency of Unprotected Intercourse (Youth) | 1.42 number of occassions | Standard Deviation 3.09 |
| FM2 and LAST Simultaneous | Changes in Frequency of Unprotected Intercourse (Youth) | 1.16 number of occassions | Standard Deviation 1.78 |
| Comparison Arm | Changes in Frequency of Unprotected Intercourse (Youth) | 1.38 number of occassions | Standard Deviation 2.93 |
p-value: <0.05MANOVA
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FM2 First, LAST Delayed | Changes in Parental Monitoring Scale (Youth) | 9.67 score on a scale | Standard Deviation 3.92 |
| FM2 and LAST Simultaneous | Changes in Parental Monitoring Scale (Youth) | 9.82 score on a scale | Standard Deviation 4.43 |
| Comparison Arm | Changes in Parental Monitoring Scale (Youth) | 10.03 score on a scale | Standard Deviation 3.93 |
p-value: <0.05MANOVA
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FM2 First, LAST Delayed | Changes in Parent Use of Positive Reinforcement Scale (Youth) | 5.95 score on a scale | Standard Deviation 3.11 |
| FM2 and LAST Simultaneous | Changes in Parent Use of Positive Reinforcement Scale (Youth) | 5.92 score on a scale | Standard Deviation 3.23 |
| Comparison Arm | Changes in Parent Use of Positive Reinforcement Scale (Youth) | 5.78 score on a scale | Standard Deviation 3.26 |
p-value: <0.05MANOVA
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FM2 First, LAST Delayed | Changes in Reproductive Health Knowledge Test Scores (Youth) | 12.79 score on a scale | Standard Deviation 6.32 |
| FM2 and LAST Simultaneous | Changes in Reproductive Health Knowledge Test Scores (Youth) | 14.66 score on a scale | Standard Deviation 6.9 |
| Comparison Arm | Changes in Reproductive Health Knowledge Test Scores (Youth) | 11.37 score on a scale | Standard Deviation 5.99 |
p-value: <0.05MANOVA
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FM2 First, LAST Delayed | Changes in Scores on Self Efficacy Beliefs Scale (Youth) | 58.99 score on a scale | Standard Deviation 47.29 |
| FM2 and LAST Simultaneous | Changes in Scores on Self Efficacy Beliefs Scale (Youth) | 71.82 score on a scale | Standard Deviation 52.68 |
| Comparison Arm | Changes in Scores on Self Efficacy Beliefs Scale (Youth) | 67.83 score on a scale | Standard Deviation 52.05 |
p-value: <0.05MANOVA
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FM2 First, LAST Delayed | Changes in Scores on the Condom Attitudes Scale (Youth) | 94.40 score on a scale | Standard Deviation 26.5 |
| FM2 and LAST Simultaneous | Changes in Scores on the Condom Attitudes Scale (Youth) | 96.65 score on a scale | Standard Deviation 31 |
| Comparison Arm | Changes in Scores on the Condom Attitudes Scale (Youth) | 92.09 score on a scale | Standard Deviation 26.85 |
p-value: <0.05MANOVA
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FM2 First, LAST Delayed | Changes on Family Communication Scale (Youth) | 23.89 score on a scale | Standard Deviation 14.58 |
| FM2 and LAST Simultaneous | Changes on Family Communication Scale (Youth) | 24.33 score on a scale | Standard Deviation 14.53 |
| Comparison Arm | Changes on Family Communication Scale (Youth) | 20.73 score on a scale | Standard Deviation 13.82 |
p-value: <0.05MANOVA
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FM2 First, LAST Delayed | Changes on Parental Responsiveness Scale (Youth) | 6.06 score on a scale | Standard Deviation 3.72 |
| FM2 and LAST Simultaneous | Changes on Parental Responsiveness Scale (Youth) | 6.41 score on a scale | Standard Deviation 3.59 |
| Comparison Arm | Changes on Parental Responsiveness Scale (Youth) | 5.23 score on a scale | Standard Deviation 3.7 |
p-value: <0.05MANOVA