Improving the Reproductive Health of Families

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving the Reproductive Health of Families

Conditions
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Reproductive Health

Intervention / Treatment
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* Behavioral: Families Matter 2
* Behavioral: Living as a Safer Teen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescent 13-18 in or near Gaborone Botswana and parent/guardian Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, STI, Unplanned pregnancy, Reproductive health of families, Adolescents