Virtual Mentorship to Support Maternal and Infant Health and Wellbeing: Assessing the Impact and Efficacy of NurturePA

NCT ID: NCT03497286

Last Updated: 2021-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-09

Study Completion Date

2021-08-01

Brief Summary

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The primary objective of this study is to determine whether the NurturePA text-based mentorship program reduces maternal stress and depressive symptoms, increases maternal knowledge, and increases engagement in language and literacy practices among new mothers relative to the control condition of periodic informational texts at the four-month data collection point.

Detailed Description

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Context: New parents in the US are typically offered little if any support with the transition to parenthood, despite the difficulty many families experience during this time and the importance of positive early parent-child interactions to children's future school and life outcomes.

Objectives: This study seeks to evaluate the impact of the NurturePA text-based mentorship program on maternal and infant health and wellbeing.

Study Design: Randomized control trial Setting/Participants: Participants will be recruited from the West Penn Hospital Maternity Ward. 200 participants (100 treatment, 100 control) will be recruited. They must be first or second time mothers of a focal infant of full term gestational age and normal birthweight. They must be current residents of Allegheny County and plan to remain in Allegheny County for the next two years.

Study Interventions and Measures: Treatment participants will be enrolled in the NurturePA text-based mentorship program and assigned a mentor with whom they can communicate. Control participants will receive periodic texts from NurturePA with information about child safety and health.

This study will measure maternal mood and stress, engagement in parent-child language and literacy activities, maternal knowledge, and child developmental outcomes.

Conditions

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Mothers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a randomized control trial design that will compare the outcomes of randomly assigned treatment and control groups after participation in the NurturePA program.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Participants in the treatment condition will be enrolled in the text-based mentorship program and will be able to engage with their assigned mentor as much or as little as they choose.

Group Type EXPERIMENTAL

Text-based mentorship

Intervention Type BEHAVIORAL

The treatment is a text-based peer-to-peer mentorship program for new mothers to promote the healthy development of young children by enhancing the parenting skills of the children's parents. Volunteer mentors who are experienced parents are paired with the parents of newborns. Mentors use text messaging to communicate with, support and encourage new parents while providing best-practice information, answers to the parents' questions, suggestions regarding activities to foster healthy development, and reminders about key milestone activities. The typical NurturePA mentor-mother pair communicates back-and-forth multiple times per week, at any time of the day.

Control

Participants in the control condition will receive periodic informational texts related to the growth and development of their new baby.

Group Type ACTIVE_COMPARATOR

Control text messaging

Intervention Type BEHAVIORAL

Control participants will receive periodic texts from NurturePA with information about child safety and health.

Interventions

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Text-based mentorship

The treatment is a text-based peer-to-peer mentorship program for new mothers to promote the healthy development of young children by enhancing the parenting skills of the children's parents. Volunteer mentors who are experienced parents are paired with the parents of newborns. Mentors use text messaging to communicate with, support and encourage new parents while providing best-practice information, answers to the parents' questions, suggestions regarding activities to foster healthy development, and reminders about key milestone activities. The typical NurturePA mentor-mother pair communicates back-and-forth multiple times per week, at any time of the day.

Intervention Type BEHAVIORAL

Control text messaging

Control participants will receive periodic texts from NurturePA with information about child safety and health.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Resident of Allegheny County
2. First time mother or mother of one other child
3. Gestational age of focal infant at birth is at or above 34 weeks
4. Birthweight of focal infant at or above 4 pounds (1814 grams)
5. Focal infant leaving hospital with mother (e.g. no extended NICU stay)
6. Planning to remain living in Allegheny County for at least two years
7. No more than one other child living full time and being cared for in the home (including non-biological children)

Exclusion Criteria

1. History of substance abuse disorder
2. Parents/guardians who, in the opinion of the Investigator, may be non-adherent with study schedules or procedures.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Lindsay Page

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lindsay C Page, Ed.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Christina Weiland, Ed.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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West Penn Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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http://nurturepa.org/

NurturePA is the non-profit organization which runs the text-based mentorship program for new mothers that we are investigating.

Other Identifiers

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PRO17090518

Identifier Type: -

Identifier Source: org_study_id

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