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NCT03900312 · ClinicalTrials.gov registry record · NA
Intergenerational Strengths-Based Program for American Indian Girls as They Transition to Adulthood
A NA study of Pregnancy and Drug Use, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT03900312: Completed NA study of Pregnancy and Drug Use, sponsored by Johns Hopkins Bloomberg School of Public Health.
NCT03900312 is a NA study of Pregnancy and Drug Use that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 65 participants, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03900312, a NA study of Pregnancy and Drug Use, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Asdzaan Be'eena' Program
Study Locations (1)
Arizona
- Johns Hopkins Center for American Indian Health - Chinle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2018-11-19 |
| Est. Completion | 2020-03-30 |
| Phase | NA |
What the finished NCT03900312 record still lists
NCT03900312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which Asdzaan Be'eena' Program is the first listed.
NCT03900312 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT03900312 about?
NCT03900312 is a clinical study titled "Intergenerational Strengths-Based Program for American Indian Girls as They Transition to Adulthood". 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 del...
What is the current status of trial NCT03900312?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2018-11-19. Estimated completion is 2020-03-30.
What conditions does trial NCT03900312 study?
This clinical trial studies the following conditions: Pregnancy, Drug Use, Alcohol Use, Sex, Sexual Activity.
What interventions are being tested in trial NCT03900312?
The interventions under investigation include: Asdzaan Be'eena' Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT03900312?
This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03900312 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03900312's enrollment target sits among peer trials
65 139th of 191 higher than 52 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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