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

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University of Pittsburgh

Status

Completed

Conditions

Mothers

Treatments

Behavioral: Control text messaging
Behavioral: Text-based mentorship

Study type

Interventional

Funder types

Other

Identifiers

NCT03497286
PRO17090518

Details and patient eligibility

About

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.

Full description

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.

Enrollment

199 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

199 participants in 2 patient groups

Treatment
Experimental group
Description:
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.
Treatment:
Behavioral: Text-based mentorship
Control
Active Comparator group
Description:
Participants in the control condition will receive periodic informational texts related to the growth and development of their new baby.
Treatment:
Behavioral: Control text messaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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