Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT
ConditionPreconception Health
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-44
SponsorMorehouse School of Medicine
About this trial
With support from the National Heart, Lung, and Blood Institute, The Center for Maternal Health Equity at Morehouse School of Medicine is conducting a research study to test the implementation of Pre-Pregnancy Counseling in community-based settings.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Self-identify as Black/ African-American
Fluent English-Speaker
Not pregnant at the time of enrollment
Own a phone
Disqualifiers
None
Trial design
Design model
Factorial
Treatments tested in this trial
SBIRT Intervention
BehavioralProject IMPACT intervention will follow a Screening, Brief Intervention, and Referral to Treatment (SBIRT) Model. In the proposed study, staff at community sites will deliver a tailored SBIRT model for people seeking to get pregnant as our "Project IMPACT intervention". SBIRT was originally developed as a public health model designed to provide universal screening, secondary prevention (detecting risky or hazardous substance use before the onset of abuse or dependence), early intervention, and treatment for people who have problematic or hazardous alcohol problems within primary care and other health care settings. Morehouse School of Medicine (MSM) has adapted this SBIRT model for people who are seeking to get pregnant to assess their risks and provide early intervention to at-risk people of reproductive age who want to get pregnant. Brief preconception counseling interventions addressing multiple behavioral risk factors have been found to be effective in prior studies.
Treatment groups
850 Participants
are divided into 2 treatment groupsGroup A: Standard Structured Follow-UpExperimental treatment 1 intervention
Group B: Enhanced Structured Follow-UpExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Implementation
Each participant will remain in the study for six months and will complete three interviews (baseline, 3-month, 6-month follow-up). The number of pre-conception counseling sessions received by community members in the standard and enhanced intervention arms will be captured at 6 months. The proposed range for the primary implementation outcome will be 0-7 visits/contacts.
Time frame
6 months2
Effectiveness
1\) 0-10 readiness ruler (inclusive of all 5 stages of change) Each participant will remain in the study for six months and will complete three interviews (baseline, 3-month, 6-month follow-up). The stage of change score will be captured at baseline, 3 and 6 months. A text message reminder will be sent to patients at 3 and 6 months to help minimize missing data. The stage of change score will be captured for control subjects in year 1 and intervention subjects during the implementation phase. All participants from both implementation strategies will be combined into one group, and this group will be compared to the control group participants.
Time frame
baseline, 3 months, 6 months3
Effectiveness
2\) 0-10 readiness ruler (inclusive of all 5 stages of change) Each participant will remain in the study for six months and will complete three interviews (baseline, 3-month, 6-month follow-up). The stage of change score will be captured at baseline, 3 and 6 months. A text message reminder will be sent to patients at 3 and 6 months to help minimize missing data. The stage of change score will be captured for control subjects in year 1 and intervention subjects during the implementation phase. All participants from both implementation strategies will be combined into one group, and this group will be compared to the control group participants.
Time frame
baseline, 3 months, 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Morehouse School of Medicine
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov