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

NCT03900312 | Completed

• 1 other identifier: 9117
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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. 1.To understand if the preconception health program is feasible and acceptable among young girls and their mothers or female caregivers
2. 2.To explore optimal implementation of the program to inform future research and scale up.
3. 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.

Conditions

Sexual Activity; Sex; Alcohol Use; Pregnancy; Drug Use

Keywords

Native American; Youth; Young Adult

Outcome Measures

Primary Outcomes (20)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

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.

Behavioral: Asdzaan Be'eena' Program

Interventions

Asdzaan Be'eena' Program BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 8 Years+
• Gender Eligibility Details: 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 Inclusion Criteria (Child): • Female, 8-11 years old
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Johns Hopkins Center for American Indian Health

Chinle, Arizona, 86503, United States

Location

MeSH Terms

Conditions

Sexual Behavior; Coitus; Alcohol Drinking

Condition Hierarchy (Ancestors)

Behavior; Drinking Behavior

Study Officials

• Allison Barlow, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: April 3, 2019
• Study Start: November 19, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)