Sexual ActivityNCT03900312
Intergenerational Strengths-Based Program for American Indian Girls as They Transition to Adulthood
A study testing Asdzaan Be'eena' Program in people with Sexual Activity and Sex, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
The investigators will conduct a pilot study to assess the acceptability, feasibility, satisfaction, and participant-level outcomes among girls and their mother/female caregiver participating in a preconception health program. Read more about this study
- Who is it for?
- Ages 8 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Activity, Sex, Alcohol Use
- What is being tested?
- Asdzaan Be'eena' Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2018to 30 Mar 2020
- 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 8 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female > 18 years of age
- Self-identify as Navajo
- Be a caregiver of a girl 8-11 years old who is available to enroll in the study
- Living within 50 miles of the Chinle (Tsaile or Pinon are also included) or Tuba City, Arizona Johns Hopkins program offices
- Willing to participate in the preconception health program
- Willing to complete all implementation and follow-up assessment
Show all 17Show fewer
- Speaks and reads English
- Not cognitively or visually impaired (able to complete questionnaires)
- Review and sign informed consent
- Female, 8-11 years old
- Have a caregiver enrolled in the study
- Living within 50 miles of the Chinle (Tsaile or Pinon are also included) or Tuba City, Arizona Johns Hopkins program offices
- Willing to participate in the preconception health program
- Willing to complete all implementation and follow-up assessments
- Speaks and reads English
- Not cognitively or visually impaired (able to complete questionnaires)
- Review and sign a study assent and have a parent/guardian sign parental permission
Who cannot join
- Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, cognitive impairment, etc.)
- Due to potential mobility of foster children, children in foster care are excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Center for American Indian Health
Chinle, Arizona, 86503
About this study
The investigators will conduct a pilot study to assess the acceptability, feasibility, satisfaction, and participant-level outcomes among girls and their mother/female caregiver participating in a preconception health program. The program was developed through an extensive formative phase and is delivered weekly over ~3 months. The investigators will enroll a total of 60 female caregivers and their 8-11 year old daughters/female children to participate in the program and evaluation. Implementation data including acceptability, feasibility and satisfaction will be collected through REDCap and paper assessments completed after each program session and at the completion of the program. Preliminary impact data will be collected through REDCap up to 3 months post-intervention completion.
The aims are as follows:
- To understand if the preconception health program is feasible and acceptable among young girls and their mothers or female caregivers
- To explore optimal implementation of the program to inform future research and scale up.
- To assess preliminary impact of the preconception health program on girls' and caregiver's knowledge, cultural connectedness, caregiver-child relationship, community and school connectedness, coping skills, parenting self-efficacy, depression, quality of life as well as substance use behaviors and intentions and intention about sexual activity.
Read the detailed description
The investigators will conduct a pilot evaluation to understand the feasibility, acceptability, satisfaction and explore preliminary impacts of a preconception health program. The primary research question is: Is the preconception health program developed through the formative phase of this study acceptable and feasible to girls and caregiver participants? The program aims to improve the overall health and wellbeing of girls and their female caregivers by decreasing and delaying the initiation of substance use and risk behaviors associated with sexual initiation among adolescent girls. A second research question is: does the preconception health program have preliminary impacts on key protective and risk factors related to substance use and risky sexual behavior among girls and their female caregivers?
The Preconception Health Program will consist of 11 sessions conducted with girls ages 8-11 and their female caregivers. 5 of the 11 sessions will be taught to groups of 8-12 girls and their mothers, and 6 of the sessions will be taught to individual girl/female caregivers' dyads. The mix of group- and home-based lessons is based on findings from the formative phase about preference for certain topics to be taught in groups vs. individual dyads. Each of the sessions (group and individual) will be 60-90 minutes in duration and delivered by a trained Family Health Coach (FHC). Group sessions will take place at a local community center in a private room. Individual dyad sessions will take place in the girls'/female caregivers home or another private place of their choosing such as our local Johns Hopkins offices. The program will be conducted over 2.5-3 months with one session occurring every week for 11 weeks. The total program duration is 660-990 minutes.
To adequately assess the primary research question, the investigators will enroll 60 dyads, grouped into three cohorts of 10 dyads each, who will complete satisfaction questionnaires after each of the program sessions and upon completion of the program. To assess preliminary impact on girls' risk for substance use and intention about sexual activity, including cultural connectedness, mother-daughter communication and psychological health and wellbeing, the investigators will deliver an evaluation conducted at baseline, upon completion of the intervention (post-intervention assessment) and 3 months following completion of the intervention (3-month follow-up assessment). The investigators will also assess program impact on female caregivers' substance use, parent-child communication and factors related to the female caregivers' wellbeing through an evaluation conducted at baseline, upon completion of the intervention (post-intervention assessment) and 3 months following completion of the intervention (3-month follow-up assessment).
- Conditions
- Sexual Activity, Sex, Alcohol Use, Pregnancy, Drug Use
- Being tested
- Asdzaan Be'eena' Program
- Keywords
- Native American, Youth, Young Adult
- Medical subject headings
- Sexual Behavior, Coitus, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asdzaan Be'eena' ProgramBehavioural
The program will consist of 11 sessions conducted with girls ages 8-11 and their female caregivers. 5 of the 11 sessions will be taught to groups of 8-12 girls and their mothers, and 6 of the sessions will be taught to individual girl/female caregivers' dyads. The mix of group- and home-based lessons is based on findings from the formative phase about preference for certain topics to be taught in groups vs. individual dyads. Each of the sessions (group and individual) will be 60-90 minutes in duration and delivered by a trained Family Health Coach (FHC). Group sessions will take place at a local community center in a private room. Individual dyad sessions will take place in the girls'/female caregivers home or another private place of their choosing such as our local Johns Hopkins offices. The program will be conducted over 2.5-3 months with one session occurring every week for 11 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The program consists of 11 sessions conducted with girls ages 8-11 and their female caregivers. 5 of the 11 sessions will be taught to groups of 8-12 girls and their mothers, and 6 of the sessions will be taught to individual girl/female caregivers' dyads. The mix of group- and home-based lessons is based on findings from the formative phase about preference for certain topics to be taught in groups vs. individual dyads. Each of the sessions (group and individual) will be 60-90 minutes in duration and delivered by a trained Family Health Coach (FHC). Group sessions will take place at a local community center in a private room. Individual dyad sessions will take place in the girls'/female caregivers home or another private place of their choosing such as our local Johns Hopkins offices. Receives: Behavioral: Asdzaan Be'eena' Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three month change in child cultural knowledge score on knowledge assessment
Investigators will measure change in knowledge from baseline and 3 months post program completion via a 4-question knowledge assessment completed by the child (score 0-100%). A higher score indicates higher (greater) knowledge.
Measured: Baseline and 3 months post implementation
Three month change in caregiver cultural knowledge score on knowledge assessment
Investigators will measure change in knowledge from baseline and 3 months post program completion via a 10-questions knowledge assessment completed by caregivers (score 0-100%). A higher score indicates higher (greater) knowledge.
Measured: Baseline and 3 months post implementation
Three month change in child reported family engagement in Navajo culture assessed by family engagement questionnaire
Family engagement in the Navajo culture will be assessed via a 4- question assessment that is on a 5-point Likert scale (score: 0-20). The assessment was created by the study team. The investigators will look at the change in total score from baseline to 3 months post implementation. A higher score indicates higher (greater) family engagement.
Measured: Baseline and 3 months post implementation
Three month change in caregiver reported family engagement in Navajo cultural assessed family engagement questionnaire
Family engagement in the Navajo culture will be assessed via a 4-question assessment that is on a 5-point Likert scale (score: 0-20). The assessment was created by the study team. The investigators will look at the change in total score from baseline to 3 months post implementation.
Measured: Baseline and 3 months post implementation
Three month change in child reported parent-child communication assessed by parent-child communication questionnaire at 3
The investigators will assess the impact of the Asdzaan Be'eena program on girls' and caregivers' communication via a 20-item assessment on a 5-point Likert scale (score: 0-100). The assessment was created by the study team. Investigators will assess the change in child reported caregiver-child communication from baseline to 3 months post program implementation.
Parental monitoring will be assessed among caregivers only via a 6-question assessment created by Silverberg and Small.
Measured: Baseline and 3 months post implementation
Three month change in caregiver reported parent-child communication assessed by parent-child communication questionnaire
The investigators will assess the impact of the Asdzaan Be'eena program on girls' and caregivers' communication via a 20-item assessment on a 5- point likert scale (score: 0-100). The assessment was created by the study team. Investigators will assess in caregiver reported caregiver-child communication from baseline to 3 months post program implementation.
Measured: Baseline and 3 months post implementation
Three month change in caregiver reported parental monitoring assessed by parental monitoring questionnaire
The investigators will assess the impact of the Asdzaan Be'eena program on parental monitoring via a 6-question assessment created by Silverberg and Small. Investigators will look at the change from baseline to 3 months post program implementation in parental monitoring as reported by caregivers via the parental monitoring scale. Parental monitoring will be assessed among caregivers only via a 6-question assessment created by Silverberg and Small. A higher score indicates a higher (better) parental monitoring.
Measured: Baseline and 3 months post implementation
Three month change in child self-esteem on a self-esteem assessment developed by study team
The investigators will assess the impact of the Asdzaan Be'eena program on child self-esteem via a 4-item assessment on a 5-point Likert scale (score: 0-20). Investigators will assess the change in total score from baseline to 3 months post implementation. A higher score indicates a higher (better) self-esteem.
Measured: Baseline and 3 months post implementation
Three month change in child self-efficacy on a self-efficacy assessment adapted from Muris 2001.
The investigators will assess the impact of the Asdzaan Be'eena program on child' self-efficacy via a 5-item assessment on a 5-point likert scale (score: 0-25). Investigators will assess the change in the total score from baseline to 3 months post implementation. Higher score=higher (better) selfefficacy Citation for scale: Muris, P. (2001). Self-Efficacy Questionnaire for Children. Journal of Psychopathology and Behavioral Assessment, 23(3), 145-149.
Measured: Baseline and 3 months post implementation
Three month change in child social support on a social support assessment developed by study team.
The investigators will assess the impact of the Asdzaan Be'eena program on child social support via a 4-item assessment on a 5-point Likert scale (score: 0-20). Investigators will assess the change in total score from baseline to 3 months post implementation. A higher score indicates a higher (more) social support.
Measured: Baseline and 3 months post implementation
Three month change in average score on risky behaviors assessment
The investigators will assess the impact of the Asdzaan Be'eena program on child attitudes related to risky behaviors via a 6-item assessment on a 5-point Likert scale (score: 0-30). Investigators will assess the change in the total score from baseline to 3 months post implementation. A higher score indicates better attitudes (less endorsement of) risk behaviors.
Measured: Baseline and 3 months post implementation
Three month change in child reproductive health knowledge via a reproductive health knowledge questionnaire
Investigators will measure change in knowledge from baseline and 3 months post program completion via a 3-question knowledge assessment completed by the child (score 0-100%). A higher score indicates more knowledge.
Measured: Baseline and 3 months post implementation
Three month change in caregiver reproductive health knowledge via a reproductive health knowledge questionnaire
Investigators will measure change in knowledge from baseline and 3 months post program completion via a 10-questions knowledge assessment completed by the caregivers (score 0-100%). A higher score indicates higher (more) knowledge.
Measured: Baseline and 3 months post implementation
Three month change in caregiver family mastery via the multicultural mastery scale
Investigators will measure family mastery via a 5-item assessment on a 5-point Likert scale (score: 0-25). Change in total score between baseline and 3 months will be utilized to assess program impact.
Measured: Baseline and 3 months post implementation
Three month change in caregiver friend mastery via the multicultural mastery scale
Investigators will measure communal mastery- friends via a 5-item assessment on a 5-point Likert scale (score: 0-25). Change in total score between baseline and 3 months will be utilized to assess program impact. A lower score indicates higher (better) mastery.
Measured: Baseline and 3 months post implementation
Three month change in caregiver self mastery via the multicultural mastery scale
Investigators will measure communal mastery- self via a 5-item assessment on a 5-point likert scale (score: 0-25). Change in total score between baseline and 3 months will be utilized to assess program impact. A lower score indicates higher (better) mastery.
Measured: Baseline and 3 months post implementation
Three month change in parental self-efficacy via the parenting agency questionnaire (Dumka, 1996)
Investigators will measure parenting self-efficacy via a 10-item assessment on a 5-point Likert scale (score: 0-50). Change in total score between baseline and 3 months will be utilized to assess program impact. A higher score indicates a higher (better) self-efficacy.
Citation: Dumka, L. E., Stoerzinger, H. D., Jackson, K. M., \& Roosaa, M. W. (1996). Examination of the cross-cultural and crosslanguage equivalence of the Parenting Self-Agency Measure. Family Relations, 45, 216-222.
Measured: Baseline and 3 months post implementation
Three month change in average score on the PHQ-9 depression screener
Investigators will measure depression via the Patient Health Questionnaire (PHQ-9) a 9-item assessment (Kroenke 2001). Change in total score between baseline and 3 months will be utilized to assess program impact.
Citation: Kroenke, K., Spitzer, R. L., \& Williams, J. B. (2001). The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine, 16(9), 606-613. https:// doi.org/10.1046/j.1525-1497.2001.016009606.x
Measured: Baseline and 3 months post implementation
Three month change in frequency of activities completed together via a parent-child activity assessment
Investigators will measure caregiver and child activities together via a 5-item assessment on a 5-point likert scale completed by the child (score: 0-25). Change in total score between baseline and 3 months will be utilized to assess program impact.
A higher score indicates more frequent activities with caregiver.
Measured: Baseline and 3 months post implementation
Three month change in percent of children reporting wanting to have a kinaalda
Investigators will measure child's attitude about having a Kinaalda via one question: "Do you want to have a Kinaalda ceremony when you get your period?". Answers include "yes" and "no". Investigators will assess the difference in the number of children who say "yes" at baseline compared to 3 months post implementation.
Measured: Baseline and 3 months post implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start19 Nov 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ActivityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Barlow, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900312
- Sponsor's protocol ID
- 9117
- Status last verified
- Jul 2020
- First submitted
- 28 Feb 2019
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intergenerational Strengths-Based Program for American Indian Girls as They Transition to Adulthood
- ClinicalTrials.gov ID
- NCT03900312
- Acronym / sponsor ID
- 9117
- Conditions
- Sexual Activity, Sex, Alcohol Use, Pregnancy, Drug Use
- Keywords
- Native American, Youth, Young Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 3 Apr 2019 (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.
The investigators will conduct a pilot study to assess the acceptability, feasibility, satisfaction, and participant-level outcomes among girls and their mother/female caregiver participating in a preconception health program. The program was developed through an extensive formative phase and is delivered weekly over ~3 months. The investigators will enroll a total of 60 female caregivers and their 8-11 year old daughters/female children to participate in the program and evaluation. Implementation data including acceptability, feasibility and satisfaction will be collected through REDCap and paper assessments completed after each program session and at the completion of the program. Preliminary impact data will be collected through REDCap up to 3 months post-intervention completion.
The aims are as follows:
- To understand if the preconception health program is feasible and acceptable among young girls and their mothers or female caregivers
- To explore optimal implementation of the program to inform future research and scale up.
- To assess preliminary impact of the preconception health program on girls' and caregiver's knowledge, cultural connectedness, caregiver-child relationship, community and school connectedness, coping skills, parenting self-efficacy, depression, quality of life as well as substance use behaviors and intentions and intention about sexual activity.
Detailed description
The investigators will conduct a pilot evaluation to understand the feasibility, acceptability, satisfaction and explore preliminary impacts of a preconception health program. The primary research question is: Is the preconception health program developed through the formative phase of this study acceptable and feasible to girls and caregiver participants? The program aims to improve the overall health and wellbeing of girls and their female caregivers by decreasing and delaying the initiation of substance use and risk behaviors associated with sexual initiation among adolescent girls. A second research question is: does the preconception health program have preliminary impacts on key protective and risk factors related to substance use and risky sexual behavior among girls and their female caregivers?
The Preconception Health Program will consist of 11 sessions conducted with girls ages 8-11 and their female caregivers. 5 of the 11 sessions will be taught to groups of 8-12 girls and their mothers, and 6 of the sessions will be taught to individual girl/female caregivers' dyads. The mix of group- and home-based lessons is based on findings from the formative phase about preference for certain topics to be taught in groups vs. individual dyads. Each of the sessions (group and individual) will be 60-90 minutes in duration and delivered by a trained Family Health Coach (FHC). Group sessions will take place at a local community center in a private room. Individual dyad sessions will take place in the girls'/female caregivers home or another private place of their choosing such as our local Johns Hopkins offices. The program will be conducted over 2.5-3 months with one session occurring every week for 11 weeks. The total program duration is 660-990 minutes.
To adequately assess the primary research question, the investigators will enroll 60 dyads, grouped into three cohorts of 10 dyads each, who will complete satisfaction questionnaires after each of the program sessions and upon completion of the program. To assess preliminary impact on girls' risk for substance use and intention about sexual activity, including cultural connectedness, mother-daughter communication and psychological health and wellbeing, the investigators will deliver an evaluation conducted at baseline, upon completion of the intervention (post-intervention assessment) and 3 months following completion of the intervention (3-month follow-up assessment). The investigators will also assess program impact on female caregivers' substance use, parent-child communication and factors related to the female caregivers' wellbeing through an evaluation conducted at baseline, upon completion of the intervention (post-intervention assessment) and 3 months following completion of the intervention (3-month follow-up assessment).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Asdzaan Be'eena' ProgramThe program consists of 11 sessions conducted with girls ages 8-11 and their female caregivers. 5 of the 11 sessions will be taught to groups of 8-12 girls and their mothers, and 6 of the sessions will be taught to individual girl/female caregivers' dyads. The mix of group- and home-based lessons is based on findings from the formative phase about preference for certain topics to be taught in groups vs. individual dyads. Each of the sessions (group and individual) will be 60-90 minutes in duration and delivered by a trained Family Health Coach (FHC). Group sessions will take place at a local community center in a private room. Individual dyad sessions will take place in the girls'/female caregivers home or another private place of their choosing such as our local Johns Hopkins offices. |
Who may qualify
- Ages
- 8 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Female > 18 years of age
- Self-identify as Navajo
- Be a caregiver of a girl 8-11 years old who is available to enroll in the study
- Living within 50 miles of the Chinle (Tsaile or Pinon are also included) or Tuba City, Arizona Johns Hopkins program offices
- Willing to participate in the preconception health program
Key exclusion criteria (2 listed)
- Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, cognitive impairment, etc.)
- Due to potential mobility of foster children, children in foster care are excluded from the study.
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 |
|---|---|---|
| Asdzaan Be'eena' ProgramThe program will consist of 11 sessions conducted with girls ages 8-11 and their female caregivers. 5 of the 11 sessions will be taught to groups of 8-12 girls and their mothers, and 6 of the sessions will be taught to individual girl/female caregivers' dyads. The mix of group- and home-based lessons is based on findings from the formative phase about preference for certain topics to be taught in groups vs. individual dyads. Each of the sessions (group and individual) will be 60-90 minutes in duration and delivered by a trained Family Health Coach (FHC). Group sessions will take place at a local community center in a private room. Individual dyad sessions will take place in the girls'/female caregivers home or another private place of their choosing such as our local Johns Hopkins offices. The program will be conducted over 2.5-3 months with one session occurring every week for 11 weeks. | Behavioural | Intervention |
Primary outcome
Three month change in child cultural knowledge score on knowledge assessment
Time frame: Baseline and 3 months post implementation
Investigators will measure change in knowledge from baseline and 3 months post program completion via a 4-question knowledge assessment completed by the child (score 0-100%). A higher score indicates higher (greater) knowledge.
Three month change in caregiver cultural knowledge score on knowledge assessment
Time frame: Baseline and 3 months post implementation
Investigators will measure change in knowledge from baseline and 3 months post program completion via a 10-questions knowledge assessment completed by caregivers (score 0-100%). A higher score indicates higher (greater) knowledge.
Three month change in child reported family engagement in Navajo culture assessed by family engagement questionnaire
Time frame: Baseline and 3 months post implementation
Family engagement in the Navajo culture will be assessed via a 4- question assessment that is on a 5-point Likert scale (score: 0-20). The assessment was created by the study team. The investigators will look at the change in total score from baseline to 3 months post implementation. A higher score indicates higher (greater) family engagement.
Three month change in caregiver reported family engagement in Navajo cultural assessed family engagement questionnaire
Time frame: Baseline and 3 months post implementation
Family engagement in the Navajo culture will be assessed via a 4-question assessment that is on a 5-point Likert scale (score: 0-20). The assessment was created by the study team. The investigators will look at the change in total score from baseline to 3 months post implementation.
Three month change in child reported parent-child communication assessed by parent-child communication questionnaire at 3
Time frame: Baseline and 3 months post implementation
The investigators will assess the impact of the Asdzaan Be'eena program on girls' and caregivers' communication via a 20-item assessment on a 5-point Likert scale (score: 0-100). The assessment was created by the study team. Investigators will assess the change in child reported caregiver-child communication from baseline to 3 months post program implementation. Parental monitoring will be assessed among caregivers only via a 6-question assessment created by Silverberg and Small.
Three month change in caregiver reported parent-child communication assessed by parent-child communication questionnaire
Time frame: Baseline and 3 months post implementation
The investigators will assess the impact of the Asdzaan Be'eena program on girls' and caregivers' communication via a 20-item assessment on a 5- point likert scale (score: 0-100). The assessment was created by the study team. Investigators will assess in caregiver reported caregiver-child communication from baseline to 3 months post program implementation.
Three month change in caregiver reported parental monitoring assessed by parental monitoring questionnaire
Time frame: Baseline and 3 months post implementation
The investigators will assess the impact of the Asdzaan Be'eena program on parental monitoring via a 6-question assessment created by Silverberg and Small. Investigators will look at the change from baseline to 3 months post program implementation in parental monitoring as reported by caregivers via the parental monitoring scale. Parental monitoring will be assessed among caregivers only via a 6-question assessment created by Silverberg and Small. A higher score indicates a higher (better) parental monitoring.
Three month change in child self-esteem on a self-esteem assessment developed by study team
Time frame: Baseline and 3 months post implementation
The investigators will assess the impact of the Asdzaan Be'eena program on child self-esteem via a 4-item assessment on a 5-point Likert scale (score: 0-20). Investigators will assess the change in total score from baseline to 3 months post implementation. A higher score indicates a higher (better) self-esteem.
Three month change in child self-efficacy on a self-efficacy assessment adapted from Muris 2001.
Time frame: Baseline and 3 months post implementation
The investigators will assess the impact of the Asdzaan Be'eena program on child' self-efficacy via a 5-item assessment on a 5-point likert scale (score: 0-25). Investigators will assess the change in the total score from baseline to 3 months post implementation. Higher score=higher (better) selfefficacy Citation for scale: Muris, P. (2001). Self-Efficacy Questionnaire for Children. Journal of Psychopathology and Behavioral Assessment, 23(3), 145-149.
Three month change in child social support on a social support assessment developed by study team.
Time frame: Baseline and 3 months post implementation
The investigators will assess the impact of the Asdzaan Be'eena program on child social support via a 4-item assessment on a 5-point Likert scale (score: 0-20). Investigators will assess the change in total score from baseline to 3 months post implementation. A higher score indicates a higher (more) social support.
Three month change in average score on risky behaviors assessment
Time frame: Baseline and 3 months post implementation
The investigators will assess the impact of the Asdzaan Be'eena program on child attitudes related to risky behaviors via a 6-item assessment on a 5-point Likert scale (score: 0-30). Investigators will assess the change in the total score from baseline to 3 months post implementation. A higher score indicates better attitudes (less endorsement of) risk behaviors.
Three month change in child reproductive health knowledge via a reproductive health knowledge questionnaire
Time frame: Baseline and 3 months post implementation
Investigators will measure change in knowledge from baseline and 3 months post program completion via a 3-question knowledge assessment completed by the child (score 0-100%). A higher score indicates more knowledge.
Three month change in caregiver reproductive health knowledge via a reproductive health knowledge questionnaire
Time frame: Baseline and 3 months post implementation
Investigators will measure change in knowledge from baseline and 3 months post program completion via a 10-questions knowledge assessment completed by the caregivers (score 0-100%). A higher score indicates higher (more) knowledge.
Three month change in caregiver family mastery via the multicultural mastery scale
Time frame: Baseline and 3 months post implementation
Investigators will measure family mastery via a 5-item assessment on a 5-point Likert scale (score: 0-25). Change in total score between baseline and 3 months will be utilized to assess program impact.
Three month change in caregiver friend mastery via the multicultural mastery scale
Time frame: Baseline and 3 months post implementation
Investigators will measure communal mastery- friends via a 5-item assessment on a 5-point Likert scale (score: 0-25). Change in total score between baseline and 3 months will be utilized to assess program impact. A lower score indicates higher (better) mastery.
Three month change in caregiver self mastery via the multicultural mastery scale
Time frame: Baseline and 3 months post implementation
Investigators will measure communal mastery- self via a 5-item assessment on a 5-point likert scale (score: 0-25). Change in total score between baseline and 3 months will be utilized to assess program impact. A lower score indicates higher (better) mastery.
Three month change in parental self-efficacy via the parenting agency questionnaire (Dumka, 1996)
Time frame: Baseline and 3 months post implementation
Investigators will measure parenting self-efficacy via a 10-item assessment on a 5-point Likert scale (score: 0-50). Change in total score between baseline and 3 months will be utilized to assess program impact. A higher score indicates a higher (better) self-efficacy. Citation: Dumka, L. E., Stoerzinger, H. D., Jackson, K. M., \& Roosaa, M. W. (1996). Examination of the cross-cultural and crosslanguage equivalence of the Parenting Self-Agency Measure. Family Relations, 45, 216-222.
Three month change in average score on the PHQ-9 depression screener
Time frame: Baseline and 3 months post implementation
Investigators will measure depression via the Patient Health Questionnaire (PHQ-9) a 9-item assessment (Kroenke 2001). Change in total score between baseline and 3 months will be utilized to assess program impact. Citation: Kroenke, K., Spitzer, R. L., \& Williams, J. B. (2001). The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine, 16(9), 606-613. https:// doi.org/10.1046/j.1525-1497.2001.016009606.x
Three month change in frequency of activities completed together via a parent-child activity assessment
Time frame: Baseline and 3 months post implementation
Investigators will measure caregiver and child activities together via a 5-item assessment on a 5-point likert scale completed by the child (score: 0-25). Change in total score between baseline and 3 months will be utilized to assess program impact. A higher score indicates more frequent activities with caregiver.
Three month change in percent of children reporting wanting to have a kinaalda
Time frame: Baseline and 3 months post implementation
Investigators will measure child's attitude about having a Kinaalda via one question: "Do you want to have a Kinaalda ceremony when you get your period?". Answers include "yes" and "no". Investigators will assess the difference in the number of children who say "yes" at baseline compared to 3 months post implementation.
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 4 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Sexual Activity
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Not yet recruitingObservational study
Spousal Support and Sexual Quality of Life in Postmenopausal Women
Postmenopausal, Support
Not yet recruiting
Genital Self İmage and Satisfaction With Genital Appearance
Women
Active, not recruiting
What Works to Prevent Violence Against Women and Girls in Madagascar
Comprehensive Sexual Education
RecruitingPhase 2/3
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
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.
Allison Barlow, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asdzaan Be'eena' Program in people with Sexual Activity and Sex, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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 17 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 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Three month change in child cultural knowledge score on knowledge assessment (time frame: Baseline and 3 months post implementation). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2020.