Clinical trial NCT03900312: Intergenerational Strengths-Based Program for American Indian Girls as They Transition to Adulthood
Official title: Intergenerational Strengths-Based Program for American Indian Girls as They Transition to Adulthood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Activity
Sex
Alcohol Use
Pregnancy
Drug Use
Keywords: Native American
Youth
Young Adult
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 65
Sex: FEMALE
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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. 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Three month change in child cultural knowledge score on knowledge assessment
timeFrame: Baseline and 3 months post implementation
measure: Three month change in caregiver cultural knowledge score on knowledge assessment
timeFrame: Baseline and 3 months post implementation
measure: Three month change in child reported family engagement in Navajo culture assessed by family engagement questionnaire
timeFrame: Baseline and 3 months post implementation
measure: Three month change in caregiver reported family engagement in Navajo cultural assessed family engagement questionnaire
timeFrame: Baseline and 3 months post implementation
measure: Three month change in child reported parent-child communication assessed by parent-child communication questionnaire at 3
timeFrame: Baseline and 3 months post implementation
measure: Three month change in caregiver reported parent-child communication assessed by parent-child communication questionnaire
timeFrame: Baseline and 3 months post implementation
measure: Three month change in caregiver reported parental monitoring assessed by parental monitoring questionnaire
timeFrame: Baseline and 3 months post implementation
measure: Three month change in child self-esteem on a self-esteem assessment developed by study team
timeFrame: Baseline and 3 months post implementation
measure: Three month change in child self-efficacy on a self-efficacy assessment adapted from Muris 2001.
timeFrame: Baseline and 3 months post implementation
measure: Three month change in child social support on a social support assessment developed by study team.
timeFrame: Baseline and 3 months post implementation
measure: Three month change in average score on risky behaviors assessment
timeFrame: Baseline and 3 months post implementation
measure: Three month change in child reproductive health knowledge via a reproductive health knowledge questionnaire
timeFrame: Baseline and 3 months post implementation
measure: Three month change in caregiver reproductive health knowledge via a reproductive health knowledge questionnaire
timeFrame: Baseline and 3 months post implementation
measure: Three month change in caregiver family mastery via the multicultural mastery scale
timeFrame: Baseline and 3 months post implementation
measure: Three month change in caregiver friend mastery via the multicultural mastery scale
timeFrame: Baseline and 3 months post implementation
measure: Three month change in caregiver self mastery via the multicultural mastery scale
timeFrame: Baseline and 3 months post implementation
measure: Three month change in parental self-efficacy via the parenting agency questionnaire (Dumka, 1996)
timeFrame: Baseline and 3 months post implementation
measure: Three month change in average score on the PHQ-9 depression screener
timeFrame: Baseline and 3 months post implementation
measure: Three month change in frequency of activities completed together via a parent-child activity assessment
timeFrame: Baseline and 3 months post implementation
measure: Three month change in percent of children reporting wanting to have a kinaalda
timeFrame: Baseline and 3 months post implementation
Secondary outcomes:
Other outcomes:
Locations:
city: Chinle
country: United States
facility: Johns Hopkins Center for American Indian Health
state: Arizona
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Allison Barlow, PhD
role: PRINCIPAL_INVESTIGATOR
References: