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Improving the Reproductive Health of Families

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ClinicalTrials.gov Identifier: NCT03858803
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Janet S. St. Lawrence, Portland State University

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.

Condition or disease Intervention/treatment Phase
Reproductive Health Behavioral: Families Matter 2 Behavioral: Living as a Safer Teen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving the Reproductive Health of Families
Estimated Study Start Date : April 22, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Arm Intervention/treatment
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
Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Other Name: FM2

Behavioral: 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.
Other Name: LAST

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
Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Other Name: FM2

Behavioral: 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.
Other Name: LAST

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
Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Other Name: FM2

Behavioral: 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.
Other Name: LAST




Primary Outcome Measures :
  1. Changes in frequency of unprotected intercourse (youth and parents) [ Time Frame: one year ]
    Self-reported frequency of unprotected intercourse occasions in past 3 months.

  2. Changes in Reproductive Health Knowledge Test scores (youth) [ Time Frame: one year ]
    Measure of knowledge about prevention of STIs, HIV, and pregnancy. Total score range 0-26. No subscales. Higher scores reflect more accurate knowledge.

  3. Changes in Condom Barriers Scale(youth) [ Time Frame: one year ]
    Total score range 0 - 140; Higher scores reflect fewer perceived barriers to condom use. No subscales

  4. Change in Attitudes toward Transactional Sex Scale (youth) [ Time Frame: one year ]
    Total score range 0 - 120, No subscales, Higher scores reflect less acceptance of transactional sex

  5. Change in number of sex partners (youth and parent) [ Time Frame: one year ]
    Change in self-reported numbers of sex partners in past three months

  6. Changes on Family Communication Scale (parents and youth) [ Time Frame: One year ]
    Total scale range 0-52, No subscales, Higher scores reflect more frequent communication between parent and child frequency

  7. Changes in scores on the Condom Attitudes Scale (youth) [ Time Frame: One year ]
    Total scale score range 0-144, No subscales, Higher scores reflect more positive attitudes toward condom use

  8. Changes in scores on Self Efficacy Beliefs Scale (youth) [ Time Frame: One year ]
    Total scale score range 0-160, No subscales, Higher scores reflect endorsement of greater self efficacy beliefs

  9. Changes on Parental Responsiveness Scale (parent and youth) [ Time Frame: One year ]
    Total scale score range 0-11, No subscales, Higher scores reflect reports of greater parental responsiveness

  10. Changes in Parent Use of Positive Reinforcement Scale (parent and youth) [ Time Frame: One year ]
    Total score range 0-12, No Subscales, Higher score reflect reports of more frequent use of positive reinforcement by parents

  11. Changes in Parental Monitoring Scale (parent and youth) [ Time Frame: One year ]
    Total scale score range 0-16, No subscales, Higher scores reflect report of greater parental monitoring



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858803


Contacts
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Contact: Janet S St. Lawrence 5034447507 jstla2@pdx.edu

Sponsors and Collaborators
Portland State University
Investigators
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Principal Investigator: Janet S St. Lawrence, Ph.D. Portland State University
Study Director: Esther S Seloilwe, Ph.D. University of Botswana

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Responsible Party: Janet S. St. Lawrence, Research Professor, Portland State University
ClinicalTrials.gov Identifier: NCT03858803     History of Changes
Other Study ID Numbers: Botswana Study
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymized data will be made available upon study completion.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janet S. St. Lawrence, Portland State University:
HIV
STI
Unplanned pregnancy
Reproductive health of families
Adolescents