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Mothers and Babies (MB) Course for Prenatal Stress

N/A

Recruiting

Led By Lauren Wakschlag, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month, 3 months, 7 months, 12 months, 24 months

Awards & highlights

Study Summary

This trial will test whether reducing maternal stress during pregnancy leads to improved neurodevelopment in babies. 100 pregnant women will be randomly assigned to either a stress-reduction intervention or a control group.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month, 3 months, 7 months, 12 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month, 3 months, 7 months, 12 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 3 months, 7 months, 12 months, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disruptive Behavior Diagnostic Observation Schedule (DB DOS)

MAP-DB

PROMIS Depression

+1 more

Secondary outcome measures

Alberta Infant Motor Scale (AIMS)

Bayley Scales of Infant Development

Behavioral Activation Depression Scale (BADS) - short form

+21 more

Other outcome measures

Family Life Impairment Scale (FLIS)

Family Relationship Index (FRI)

PROMIS Anxiety

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment3 Interventions

The first MB course session and technology training will take place in-person, prior to 23 weeks gestation. The Mothers and Babies course (MB) is a 12-session manualized stress-reduction intervention that will be delivered to participants, prenatally, with an integrated technology suite designed for timely detection and response to maternal stress. Sessions are delivered 1-on-1 with a trained facilitator and are based on principles of cognitive-behavioral therapy (CBT) and attachment theory. The MB course is divided into 3 sections: 1) Pleasant Activities; 2) Thoughts; 3) Contact with Others. Throughout each module, mindfulness skills training will be integrated as a strategy to help "center" participants. All participants will receive a Participant Manual for Families, containing worksheets that correspond to the 12 sessions.

Group II: Stress monitoring (control) groupActive Control1 Intervention

This group will not receive any additional intervention but will engage in stress monitoring via biosensors and EMA text messages through the 14 week period

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,131 Total Patients Enrolled

1 Trials studying Prenatal Stress

17 Patients Enrolled for Prenatal Stress

Ann & Robert H Lurie Children's Hospital of ChicagoOTHER

256 Previous Clinical Trials

5,187,780 Total Patients Enrolled

1 Trials studying Prenatal Stress

17 Patients Enrolled for Prenatal Stress

Lauren Wakschlag, PhDPrincipal InvestigatorNorthwestern University

Media Library

Mothers and Babies (MB) Course Clinical Trial Eligibility Overview. Trial Name: NCT05052281 — N/A

Prenatal Stress Research Study Groups: Intervention group, Stress monitoring (control) group

Mothers and Babies (MB) Course 2023 Treatment Timeline for Medical Study. Trial Name: NCT05052281 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the current clinical trial being participated in?

"That is correct. According to information on clinicaltrials.gov, the trial has been active since July 15th 2019 and was last updated on September 11th 2021. This study calls for 100 volunteers from 1 location to take part in it."

Answered by AI

Would I qualify to join this research initiative?

"This medical trial is recruiting 100 people who have experienced prenatal stress, aged between 18 and 65. Applicants must meet the following conditions: being enrolled in a prenatal care clinic at Northwestern University before 22 weeks gestation; owning a smartphone with WiFi access for 12 weeks; consenting to receive text messages and respond to online surveys using their phone; wearing an adhesive wireless sensor named BioStamp daily throughout their participation; agreeing to let their child participate in neurodevelopmental assessments from birth until one year of age."

Answered by AI

Is the age threshold for participants in this experiment at least twenty years old?

"The criteria for enrollment in this trial stipulates that prospective patients must be 18 years of age or older, and under the age 65."

Answered by AI

Are there still opportunities to take part in this experiment?

"Affirmative. Data from clinicaltrials.gov verifies that this medical investigation, first announced on July 15th 2019, is currently recruiting participants. Approximately 100 individuals are needed to be recruited for the study at one site."

Answered by AI