Intergenerational Strengths-Based Program for American Indian Girls as They Transition to Adulthood

Pregnancy Clinical Trial

Official title:

Intergenerational Strengths-Based Program for American Indian Girls as They Transition to Adulthood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03900312
• Other study ID #: 9117
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2020
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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:

1. To understand if the preconception health program is feasible and acceptable among young girls and their mothers or female caregivers

2. To explore optimal implementation of the program to inform future research and scale up.

3. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 8 Years and older

Eligibility

Inclusion Criteria (Caregivers):

• 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

• Speaks and reads English

• Not cognitively or visually impaired (able to complete questionnaires)

• Review and sign informed consent

Inclusion Criteria (Child):

• 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

Exclusion Criteria (child and caregiver):

• 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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use
• Drug Use
• Pregnancy
• Sex
• Sexual Activity

Intervention

Behavioral:
• Asdzaan Be'eena' Program
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.

Locations

Country	Name	City	State
United States	Johns Hopkins Center for American Indian Health	Chinle	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation
Primary	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.	Baseline and 3 months post implementation