Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT03900312
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2019-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intergenerational Strengths-Based Program for American Indian Girls as They Transition to Adulthood
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Study Overview
Official Title:
Intergenerational Strengths-Based Program for American Indian Girls as They Transition to Adulthood
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: