Parent-Child RelationsNCT03411577
Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program
A study testing Behavioral Intervention in people with Parent-Child Relations and HIV Prevention, run by Boston College.
Trial summary
Caribbean nations, including Jamaica, exhibit HIV rates that are second only to sub-Saharan Africa. Jamaican young women and adolescent girls are at particularly high risk due to a number of cultural factors, gender norms, partnering with older male partners, and lack of knowledge and skills related to sexual refusal… Read more about this study
- Who is it for?
- Ages 13 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, HIV Prevention, Adolescent Behavior
- What is being tested?
- Behavioral Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 662 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 2007to 30 Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- age between 13- to 17-years, inclusive
- resident of one of the three parishes in and around Kingston, Jamaica (the study area)
- plan to reside in the "study area" for the next 12 months
- able to read, write and understand English
- unmarried and
- agrees to participate and
Show all 12Show fewer
- mother or primary female guardian also agrees to participate.
- age greater than 18
- resident of one of the three parishes in and around Kingston, Jamaica (the study area)
- plan to reside in the "study area" for the next 12 months
- able to read, write and understand English and
- agrees to participate
Who cannot join
- adolescent and/or mother who is/are disruptive and/or otherwise unable to participate in small group intervention activities
- adolescent who is married
About this study
Caribbean nations, including Jamaica, exhibit HIV rates that are second only to sub-Saharan Africa. Jamaican young women and adolescent girls are at particularly high risk due to a number of cultural factors, gender norms, partnering with older male partners, and lack of knowledge and skills related to sexual refusal and HIV prevention. U.S. studies have shown that mothers may act as a key influence of their daughters' sexual risk beliefs and behaviors. However, no such studies have documented these effects outside of the U.S. and no studies have evaluated HIV risk-reduction interventions with Jamaican adolescent girls and their mothers. Hence, the purpose of this study is to partner with the University of the West Indies, Jamaican community based organizations (CBOs) and families in order to develop and test a culture-specific mother-daughter HIV risk-reduction intervention in a randomized field experiment. Specifically, the investigative team will evaluate whether a culture-specific, theory-based, skill-building intervention with Jamaican adolescent girls and their mothers can directly and/or indirectly reduce these girls' HIV risk-associated sexual behaviors. Jamaican girls, ages 13 - 17, and their mothers/female guardians will be recruited from CBOs and randomly assigned to either: (a) a mother-daughter HIV risk-reduction intervention condition or (b) a "no intervention" waitlist control condition. The HIV risk-reduction intervention includes 12 1-hour modules scheduled over 2 days and implemented by trained adult Jamaican women (nurses and CBO staff). The mother component is designed to increase those parenting behaviors (e.g., monitoring and parent-teen sexual risk communication [PTSRC]) associated with reduced adolescent sexual risk-taking; the teen component is designed to improve girls' beliefs and skills related to abstinence, sexual negotiation and condom use. A "waitlist" control condition is being employed as the proposed project is a pilot study of the HIV risk-reduction intervention. Primary outcomes include mothers'/daughters' reports of parenting behaviors (monitoring and PTSRC) and daughters' self-reports of sexual risk behaviors (sexual intercourse, unprotected sex, condom use, number of partners). Secondary outcomes include daughters' STI rates, mothers' beliefs regarding parenting behaviors and daughters beliefs regarding sexual risk behaviors.
Read the detailed description
Caribbean nations, including Jamaica, exhibit HIV rates that are second only to sub-Saharan Africa. Jamaican young women and adolescent girls are at particularly high risk for HIV and other sexually transmitted infections (STIs) due to a number of cultural factors (including male-dominated gender norms and older male partners) and lack of knowledge and skills related to sexual communication, refusal and HIV prevention. Reducing the sexual risk behaviors of Jamaican adolescent females is critical to reducing their risk for HIV/STIs. U.S. studies have shown that parents, particularly mothers, may act as key influences of their daughters' sexual risk beliefs and behaviors. However, no studies have documented these parental effects outside of the U.S. and no studies have evaluated the effectiveness of family-based HIV risk-reduction interventions with international populations, including Jamaican adolescents. Further, it is not yet known whether the instruments used to assess the theoretical constructs of interest are culturally sensitive or appropriate for use with Jamaican adolescents and adults. Hence, the broad objective of this proposal is to develop and test a culturally sensitive, theory-based, gender-specific Jamaican mother-daughter HIV risk-reduction intervention by using community-based participatory research methods and existing collaborative relationships between investigators from the New York University, the University of Pennsylvania Center for Health Disparities Research (PENN) and the University of the West Indies (UWI), Mona Campus. Building upon already completed preliminary elicitation research with Jamaican adolescents, parents, teachers and stakeholders, the investigative team proposes to a) conduct in-depth elicitation research into the social, cultural and family factors that influence HIV-related sexual risk behaviors among Jamaican adolescent girls; b) collaboratively develop a culturally appropriate, gender specific, theory-based mother-daughter HIV risk reduction intervention for Jamaican adolescent girls and their mothers; c) enhance the research capacity of the UWI School of Nursing and the sustainability of the intervention program; d) assess the cultural appropriateness of study instruments and adapt and refine as needed; and e) evaluate the effectiveness of the mother-daughter HIV/STI risk reduction intervention through a randomized pilot study. Although the term "mother" is used throughout the application, it is defined based upon the preliminary elicitation research already completed in Jamaica. The term "mother" will be used to represent the primary female guardian or caregiver; this may be the mother, step-mother, aunt, grandmother or other related or unrelated female guardian or caregiver. In the proposed pilot study, the plan is to recruit 360 Jamaican adolescent females, ages 13 - 17 years, and their mothers from non-governmental community-based organizations (CBOs) in and around Kingston, Jamaica and randomly assign them to either a mother-daughter HIV/STI risk-reduction intervention condition or a "no intervention" waitlist control condition that includes only a brief educational activity addressing heart disease. The HIV risk-reduction intervention will be implemented by trained adult Jamaican women (nurses and CBO staff). The adolescent component is designed to reduce HIV-related sexual risk behaviors (e.g., sexual intercourse, unprotected intercourse, multiple partners); the mother component is designed to increase those parenting behaviors (e.g., monitoring and parent-teen sexual risk communication [PTSRC]) associated with reduced adolescent sexual risk-taking. A "no intervention" waitlist control condition is being employed as the proposed project is a pilot study of the HIV/STI risk-reduction intervention. Should the pilot study find evidence of intervention effectiveness, a full RCT study with long-term follow-up and examination of moderation of intervention effects will be proposed in a subsequent application.
There are four specific aims for the proposed project. Aim 1 is to conduct broad, in-depth elicitation research using community-based participatory research (CBPR) methods in order to elucidate the social, cultural and family factors that influence Jamaican adolescent girls' sexual risk-taking during Years 01 and 02. Aim 2 is to develop a culturally appropriate, gender specific, theory-based, skill-building mother-daughter HIV/STI risk-reduction intervention during Year 02. Aim 3 is to evaluate the cultural appropriateness of our commonly used measures and research instruments using both qualitative and quantitative methods in Year 02. The remaining Aims evaluate the effectiveness of the Jamaican Mother-Daughter HIV/STI Risk-Reduction Project through a randomized pilot study. Aim 4A is to examine whether mothers in the HIV/STI risk-reduction intervention condition show a greater increase in intentions and actual parenting behaviors (monitoring and PCSC) at 3- and 6-month follow-ups compared with mothers in the control group. Aim 4B is to examine whether adolescent girls in the HIV/STI risk-reduction intervention condition show a greater increase in intentions and reduction in actual sexual risk behaviors (sexual intercourse, unprotected intercourse, number of sexual partners) at 3- and 6-month follow-ups compared with girls in the control group. Aim 4C is to examine whether adolescents in the HIV/STI risk-reduction intervention exhibit a lower incidence of clinically documented STIs at 6-month follow-up compared with the adolescents in the control condition. Aim 4D is to identify why and how the mother-daughter HIV/STI risk-reduction intervention works (i.e., mediation of effects). The mother-daughter intervention is based on a family expansion of the Theory of Planned Behavior. The intervention is intended to affect the adolescents' sexual risk behaviors (abstinence, intercourse, unprotected intercourse, condom use, number of partners) by affecting their behavioral, normative and control beliefs and intentions toward safer sex and sexual risk behaviors. It is also designed to affect mothers' key parenting behaviors (monitoring and PTSRC) by affecting their behavioral beliefs, normative beliefs, control beliefs, and intentions toward those parenting behaviors. Parenting behaviors should, in turn, indirectly affect adolescents' sexual risk beliefs, intentions and behaviors. Thus, these theoretical mediators will be assessed in order to understand why the intervention is effective or not. Findings from this study will contribute to the development of effective HIV/STI risk-reduction programs for Jamaican adolescent girls. Significant information will also be gained regarding the design of effective family-based interventions, how to partner with international organizations and communities, and how to develop culturally appropriate instruments and effective HIV risk-reduction interventions for use with international populations at highest risk for HIV/AIDS.
- Conditions
- Parent-Child Relations, HIV Prevention, Adolescent Behavior
- Being tested
- Behavioral Intervention
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention | Experimental | The adolescent HIV/STI risk-reduction intervention aims to: (a) increase knowledge of HIV risk and prevention; (b) strengthen behavioral beliefs regarding abstinence and safer sex; (c) increase self-efficacy and intentions to avoid unsafe sex; and (d) increase sexual communication and refusal skills. The mother component includes much of the same prevention knowledge and addresses parent-teen sexual risk communication, monitoring, and sexual role modeling. Interventions are held on two consecutive Saturdays for 6 hours each day. Mothers' groups meet separately from daughters' groups, although the groups will come together for the last module of each day. Receives: Other: Behavioral Intervention |
| Control Group | No intervention | The control / comparison group is essentially a "no intervention / wait-list" control group. However, during pilot testing, participants expressed a strong desire to engage in some type of health activity. As a result, the control group members, both mothers and daughters, participated in a brief educational activity on reducing risk for cardiovascular disease. The educational activity was limited to a few hours on one Saturday. Participants returned the following week to complete post-test questionnaires along with the participants in the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adolescent girls' baseline self-reported frequency of condom use at 3 and 6 months
Questionnaire - self-reported single item asking frequency of condom use during past 3 months; scores range from 1 - 5; higher scores indicate greater frequency of condom use
Measured: Assessed at baseline, 3- and 6-months; reported for past 3 months
Secondary outcomes (6)
Adolescent girls' clinically documented STIs
Urine pcr tests for chlamydia and gonorrhea
Measured: Assessed at baseline and 6-month follow-up
Change in adolescent girls' baseline self-reported condom use intentions at 3 and 6 months
Questionnaire - self-reported single item asking intentions to use condoms during next 3 months; scores range from 1 to 5; higher scores indicate greater intentions
Measured: Assessed at baseline, 3- and 6-months; reported for next 3 months
Change in adolescent girls' baseline HIV knowledge scale scores at 3 and 6 months
Questionnaire - HIV/AIDS Knowledge Scale - 19 items; scores range from 0 - 19 with higher scores indicating greater amounts of knowledge
Measured: Assessed at baseline and 3- and 6-month follow-up
Changes in mothers' baseline HIV knowledge scale scores at 3 and 6 months
Questionnaire - HIV/AIDS Knowledge Scale - 19 items; scores range from 0 - 19 with higher scores indicating greater amounts of knowledge
Measured: Assessed at baseline and 3- and 6-month follow-up
Change in mothers' baseline parental monitoring scale scores at 3 and 6 months
Questionnaire - self-reported 10-item scale of parental monitoring reported by daughters ; total scores range from 10 - 50; higher scores indicate more parental monitoring/supervision
Measured: Assessed at baseline and 3- and 6-month follow-up; reported for past 3 months
Change in adolescent girls' baseline parent-teen sexual risk communication (PTSRC) scale scores at 3 and 6 months
Questionnaire - PTSRC-III scale; 8 items; total scores range from 5 - 40; higher scores indicate greater sexual communication
Measured: Assessed at baseline and 3- and 6-month follow-up; reported for past 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start29 Sep 2007
- Primary completion28 Jul 2011
- Study completion30 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies 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
- Parallel groups
- Model description
- Mother-daughter dyads were randomly assigned to either HIV risk-reduction intervention group or control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 662 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- The University of The West Indies, University of Pennsylvania, New York University
- Responsible party
- Principal investigator, Mary Katherine Hutchinson, Boston College
- Investigators
- Mary K Hutchinson, PhD, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411577
- Sponsor's protocol ID
- R01NR010478
- Status last verified
- Jan 2018
- First submitted
- 3 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decisions regarding data sharing will be made on a case-by-case basis. Those who would like to request data should contact the principal investigator.
Publications
Hutchinson MK, Smith TK, Waldron N, Kahwa E, Hewitt HH, Hamilton PI, Kang SY. Validation of the Jamaican Maternal Sexual Role Modelling Questionnaire. West Indian Med J. 2012 Dec;61(9):897-902. doi: 10.7727/wimj.2011.198.
PubMed 24020230Waldron, N., Hutchinson, M.K., Hewitt, H., Kahwa, E., & Hamilton, P. (2012). Cross-cultural psychometric assessment of the parent-teen sexual risk communication scale in Jamaica. Open Journal of Preventive Medicine, 2(2), 205-213
Hutchinson MK, Wood EB. Reconceptualizing adolescent sexual risk in a parent-based expansion of the Theory of Planned Behavior. J Nurs Scholarsh. 2007;39(2):141-6. doi: 10.1111/j.1547-5069.2007.00159.x.
PubMed 17535314Ajzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50, 179-211.
Hutchinson MK. The Parent-Teen Sexual Risk Communication Scale (PTSRC-III): instrument development and psychometrics. Nurs Res. 2007 Jan-Feb;56(1):1-8. doi: 10.1097/00006199-200701000-00001.
PubMed 17179868Hutchinson MK, Jemmott LS, Wood EB, Hewitt H, Kahwa E, Waldron N, Bonaparte B. Culture-specific factors contributing to HIV risk among Jamaican adolescents. J Assoc Nurses AIDS Care. 2007 Mar-Apr;18(2):35-47. doi: 10.1016/j.jana.2007.01.008.
PubMed 17403495Kang SY, Hutchinson MK, Waldron N. Characteristics related to sexual experience and condom use among Jamaican female adolescents. J Health Care Poor Underserved. 2013 Feb;24(1):220-32. doi: 10.1353/hpu.2013.0023.
PubMed 23377730Hutchinson MK, Kahwa E, Waldron N, Hepburn Brown C, Hamilton PI, Hewitt HH, Aiken J, Cederbaum J, Alter E, Sweet Jemmott L. Jamaican mothers' influences of adolescent girls' sexual beliefs and behaviors. J Nurs Scholarsh. 2012 Mar;44(1):27-35. doi: 10.1111/j.1547-5069.2011.01431.x. Epub 2012 Feb 16.
PubMed 22339731
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program
- ClinicalTrials.gov ID
- NCT03411577
- Acronym / sponsor ID
- R01NR010478
- Conditions
- Parent-Child Relations, HIV Prevention, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- The University of The West Indies, University of Pennsylvania, New York University
- Study start
- 29 Sep 2007 (actual)
- Primary completion
- 28 Jul 2011 (actual)
- Study completion
- 30 Jun 2012 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Caribbean nations, including Jamaica, exhibit HIV rates that are second only to sub-Saharan Africa. Jamaican young women and adolescent girls are at particularly high risk due to a number of cultural factors, gender norms, partnering with older male partners, and lack of knowledge and skills related to sexual refusal and HIV prevention. U.S. studies have shown that mothers may act as a key influence of their daughters' sexual risk beliefs and behaviors. However, no such studies have documented these effects outside of the U.S. and no studies have evaluated HIV risk-reduction interventions with Jamaican adolescent girls and their mothers. Hence, the purpose of this study is to partner with the University of the West Indies, Jamaican community based organizations (CBOs) and families in order to develop and test a culture-specific mother-daughter HIV risk-reduction intervention in a randomized field experiment. Specifically, the investigative team will evaluate whether a culture-specific, theory-based, skill-building intervention with Jamaican adolescent girls and their mothers can directly and/or indirectly reduce these girls' HIV risk-associated sexual behaviors. Jamaican girls, ages 13 - 17, and their mothers/female guardians will be recruited from CBOs and randomly assigned to either: (a) a mother-daughter HIV risk-reduction intervention condition or (b) a "no intervention" waitlist control condition. The HIV risk-reduction intervention includes 12 1-hour modules scheduled over 2 days and implemented by trained adult Jamaican women (nurses and CBO staff). The mother component is designed to increase those parenting behaviors (e.g., monitoring and parent-teen sexual risk communication [PTSRC]) associated with reduced adolescent sexual risk-taking; the teen component is designed to improve girls' beliefs and skills related to abstinence, sexual negotiation and condom use. A "waitlist" control condition is being employed as the proposed project is a pilot study of the HIV risk-reduction intervention. Primary outcomes include mothers'/daughters' reports of parenting behaviors (monitoring and PTSRC) and daughters' self-reports of sexual risk behaviors (sexual intercourse, unprotected sex, condom use, number of partners). Secondary outcomes include daughters' STI rates, mothers' beliefs regarding parenting behaviors and daughters beliefs regarding sexual risk behaviors.
Detailed description
Caribbean nations, including Jamaica, exhibit HIV rates that are second only to sub-Saharan Africa. Jamaican young women and adolescent girls are at particularly high risk for HIV and other sexually transmitted infections (STIs) due to a number of cultural factors (including male-dominated gender norms and older male partners) and lack of knowledge and skills related to sexual communication, refusal and HIV prevention. Reducing the sexual risk behaviors of Jamaican adolescent females is critical to reducing their risk for HIV/STIs. U.S. studies have shown that parents, particularly mothers, may act as key influences of their daughters' sexual risk beliefs and behaviors. However, no studies have documented these parental effects outside of the U.S. and no studies have evaluated the effectiveness of family-based HIV risk-reduction interventions with international populations, including Jamaican adolescents. Further, it is not yet known whether the instruments used to assess the theoretical constructs of interest are culturally sensitive or appropriate for use with Jamaican adolescents and adults. Hence, the broad objective of this proposal is to develop and test a culturally sensitive, theory-based, gender-specific Jamaican mother-daughter HIV risk-reduction intervention by using community-based participatory research methods and existing collaborative relationships between investigators from the New York University, the University of Pennsylvania Center for Health Disparities Research (PENN) and the University of the West Indies (UWI), Mona Campus. Building upon already completed preliminary elicitation research with Jamaican adolescents, parents, teachers and stakeholders, the investigative team proposes to a) conduct in-depth elicitation research into the social, cultural and family factors that influence HIV-related sexual risk behaviors among Jamaican adolescent girls; b) collaboratively develop a culturally appropriate, gender specific, theory-based mother-daughter HIV risk reduction intervention for Jamaican adolescent girls and their mothers; c) enhance the research capacity of the UWI School of Nursing and the sustainability of the intervention program; d) assess the cultural appropriateness of study instruments and adapt and refine as needed; and e) evaluate the effectiveness of the mother-daughter HIV/STI risk reduction intervention through a randomized pilot study. Although the term "mother" is used throughout the application, it is defined based upon the preliminary elicitation research already completed in Jamaica. The term "mother" will be used to represent the primary female guardian or caregiver; this may be the mother, step-mother, aunt, grandmother or other related or unrelated female guardian or caregiver. In the proposed pilot study, the plan is to recruit 360 Jamaican adolescent females, ages 13 - 17 years, and their mothers from non-governmental community-based organizations (CBOs) in and around Kingston, Jamaica and randomly assign them to either a mother-daughter HIV/STI risk-reduction intervention condition or a "no intervention" waitlist control condition that includes only a brief educational activity addressing heart disease. The HIV risk-reduction intervention will be implemented by trained adult Jamaican women (nurses and CBO staff). The adolescent component is designed to reduce HIV-related sexual risk behaviors (e.g., sexual intercourse, unprotected intercourse, multiple partners); the mother component is designed to increase those parenting behaviors (e.g., monitoring and parent-teen sexual risk communication [PTSRC]) associated with reduced adolescent sexual risk-taking. A "no intervention" waitlist control condition is being employed as the proposed project is a pilot study of the HIV/STI risk-reduction intervention. Should the pilot study find evidence of intervention effectiveness, a full RCT study with long-term follow-up and examination of moderation of intervention effects will be proposed in a subsequent application.
There are four specific aims for the proposed project. Aim 1 is to conduct broad, in-depth elicitation research using community-based participatory research (CBPR) methods in order to elucidate the social, cultural and family factors that influence Jamaican adolescent girls' sexual risk-taking during Years 01 and 02. Aim 2 is to develop a culturally appropriate, gender specific, theory-based, skill-building mother-daughter HIV/STI risk-reduction intervention during Year 02. Aim 3 is to evaluate the cultural appropriateness of our commonly used measures and research instruments using both qualitative and quantitative methods in Year 02. The remaining Aims evaluate the effectiveness of the Jamaican Mother-Daughter HIV/STI Risk-Reduction Project through a randomized pilot study. Aim 4A is to examine whether mothers in the HIV/STI risk-reduction intervention condition show a greater increase in intentions and actual parenting behaviors (monitoring and PCSC) at 3- and 6-month follow-ups compared with mothers in the control group. Aim 4B is to examine whether adolescent girls in the HIV/STI risk-reduction intervention condition show a greater increase in intentions and reduction in actual sexual risk behaviors (sexual intercourse, unprotected intercourse, number of sexual partners) at 3- and 6-month follow-ups compared with girls in the control group. Aim 4C is to examine whether adolescents in the HIV/STI risk-reduction intervention exhibit a lower incidence of clinically documented STIs at 6-month follow-up compared with the adolescents in the control condition. Aim 4D is to identify why and how the mother-daughter HIV/STI risk-reduction intervention works (i.e., mediation of effects). The mother-daughter intervention is based on a family expansion of the Theory of Planned Behavior. The intervention is intended to affect the adolescents' sexual risk behaviors (abstinence, intercourse, unprotected intercourse, condom use, number of partners) by affecting their behavioral, normative and control beliefs and intentions toward safer sex and sexual risk behaviors. It is also designed to affect mothers' key parenting behaviors (monitoring and PTSRC) by affecting their behavioral beliefs, normative beliefs, control beliefs, and intentions toward those parenting behaviors. Parenting behaviors should, in turn, indirectly affect adolescents' sexual risk beliefs, intentions and behaviors. Thus, these theoretical mediators will be assessed in order to understand why the intervention is effective or not. Findings from this study will contribute to the development of effective HIV/STI risk-reduction programs for Jamaican adolescent girls. Significant information will also be gained regarding the design of effective family-based interventions, how to partner with international organizations and communities, and how to develop culturally appropriate instruments and effective HIV risk-reduction interventions for use with international populations at highest risk for HIV/AIDS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Mother-daughter dyads were randomly assigned to either HIV risk-reduction intervention group or control group
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention | Experimental | Other: Behavioral InterventionThe adolescent HIV/STI risk-reduction intervention aims to: (a) increase knowledge of HIV risk and prevention; (b) strengthen behavioral beliefs regarding abstinence and safer sex; (c) increase self-efficacy and intentions to avoid unsafe sex; and (d) increase sexual communication and refusal skills. The mother component includes much of the same prevention knowledge and addresses parent-teen sexual risk communication, monitoring, and sexual role modeling. Interventions are held on two consecutive Saturdays for 6 hours each day. Mothers' groups meet separately from daughters' groups, although the groups will come together for the last module of each day. |
| Control Group | No intervention | –The control / comparison group is essentially a "no intervention / wait-list" control group. However, during pilot testing, participants expressed a strong desire to engage in some type of health activity. As a result, the control group members, both mothers and daughters, participated in a brief educational activity on reducing risk for cardiovascular disease. The educational activity was limited to a few hours on one Saturday. Participants returned the following week to complete post-test questionnaires along with the participants in the experimental group. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- age between 13- to 17-years, inclusive
- resident of one of the three parishes in and around Kingston, Jamaica (the study area)
- plan to reside in the "study area" for the next 12 months
- able to read, write and understand English
- unmarried and
Key exclusion criteria (2 listed)
- adolescent and/or mother who is/are disruptive and/or otherwise unable to participate in small group intervention activities
- adolescent who is married
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 |
|---|---|---|
| Behavioral Intervention | Other | Behavioral Intervention |
Primary outcome
Change in adolescent girls' baseline self-reported frequency of condom use at 3 and 6 months
Time frame: Assessed at baseline, 3- and 6-months; reported for past 3 months
Questionnaire - self-reported single item asking frequency of condom use during past 3 months; scores range from 1 - 5; higher scores indicate greater frequency of condom use
6 secondary outcomes
Adolescent girls' clinically documented STIs
Time frame: Assessed at baseline and 6-month follow-up
Change in adolescent girls' baseline self-reported condom use intentions at 3 and 6 months
Time frame: Assessed at baseline, 3- and 6-months; reported for next 3 months
Change in adolescent girls' baseline HIV knowledge scale scores at 3 and 6 months
Time frame: Assessed at baseline and 3- and 6-month follow-up
Changes in mothers' baseline HIV knowledge scale scores at 3 and 6 months
Time frame: Assessed at baseline and 3- and 6-month follow-up
Change in mothers' baseline parental monitoring scale scores at 3 and 6 months
Time frame: Assessed at baseline and 3- and 6-month follow-up; reported for past 3 months
Change in adolescent girls' baseline parent-teen sexual risk communication (PTSRC) scale scores at 3 and 6 months
Time frame: Assessed at baseline and 3- and 6-month follow-up; reported for past 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Background: PubMed 24020230Hutchinson MK, Smith TK, Waldron N, Kahwa E, Hewitt HH, Hamilton PI, Kang SY. Validation of the Jamaican Maternal Sexual Role Modelling Questionnaire. West Indian Med J. 2012 Dec;61(9):897-902. doi: 10.7727/wimj.2011.198.
- BackgroundWaldron, N., Hutchinson, M.K., Hewitt, H., Kahwa, E., & Hamilton, P. (2012). Cross-cultural psychometric assessment of the parent-teen sexual risk communication scale in Jamaica. Open Journal of Preventive Medicine, 2(2), 205-213
- Background: PubMed 17535314Hutchinson MK, Wood EB. Reconceptualizing adolescent sexual risk in a parent-based expansion of the Theory of Planned Behavior. J Nurs Scholarsh. 2007;39(2):141-6. doi: 10.1111/j.1547-5069.2007.00159.x.
- BackgroundAjzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50, 179-211.
- Background: PubMed 17179868Hutchinson MK. The Parent-Teen Sexual Risk Communication Scale (PTSRC-III): instrument development and psychometrics. Nurs Res. 2007 Jan-Feb;56(1):1-8. doi: 10.1097/00006199-200701000-00001.
- Results publication: PubMed 17403495Hutchinson MK, Jemmott LS, Wood EB, Hewitt H, Kahwa E, Waldron N, Bonaparte B. Culture-specific factors contributing to HIV risk among Jamaican adolescents. J Assoc Nurses AIDS Care. 2007 Mar-Apr;18(2):35-47. doi: 10.1016/j.jana.2007.01.008.
- Results publication: PubMed 23377730Kang SY, Hutchinson MK, Waldron N. Characteristics related to sexual experience and condom use among Jamaican female adolescents. J Health Care Poor Underserved. 2013 Feb;24(1):220-32. doi: 10.1353/hpu.2013.0023.
- Results publication: PubMed 22339731Hutchinson MK, Kahwa E, Waldron N, Hepburn Brown C, Hamilton PI, Hewitt HH, Aiken J, Cederbaum J, Alter E, Sweet Jemmott L. Jamaican mothers' influences of adolescent girls' sexual beliefs and behaviors. J Nurs Scholarsh. 2012 Mar;44(1):27-35. doi: 10.1111/j.1547-5069.2011.01431.x. Epub 2012 Feb 16.
- Individual participant dataSharing planned: Undecided. Decisions regarding data sharing will be made on a case-by-case basis. Those who would like to request data should contact the principal investigator.
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A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
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.
Mary K Hutchinson, PhD principal investigator
Boston College
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention in people with Parent-Child Relations and HIV Prevention, run by Boston College.
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 12 inclusion and 2 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 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in adolescent girls' baseline self-reported frequency of condom use at 3 and 6 months (time frame: Assessed at baseline, 3- and 6-months; reported for past 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03411577, which also lists 8 linked publications.
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 26 Jan 2018.