Clinical trial NCT03497286: Virtual Mentorship to Support Maternal and Infant Health and Wellbeing: Assessing the Impact and Efficacy of NurturePA
Official title: Virtual Mentorship to Support Maternal and Infant Health and Wellbeing: Assessing the Impact and Efficacy of NurturePA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mothers
Keywords: maternal health
maternal stress
infant health
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
name: University of Michigan
First posted: 2018-04-13
Enrollment: 199
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parental Stress
timeFrame: 4 months from study start
measure: Parental stress
timeFrame: 18 months from study start
Secondary outcomes:
measure: Maternal Knowledge
timeFrame: 4 months from study start
measure: Engagement in Language and Literacy Activities
timeFrame: 4 months from study start
measure: Engagement in Language and Literacy Activities
timeFrame: 18 months from study start
measure: Child Development
timeFrame: 4 months from study start
measure: Child Development
timeFrame: 18 months from study start
measure: WIC Usage
timeFrame: 4 and 18 months from study start
measure: Early Language and Development Screening
timeFrame: 4 and 18 months from study start
measure: Edinburgh Postnatal Depression Scale
timeFrame: 4 months from start of the study
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: West Penn Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Lindsay C Page, Ed.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Christina Weiland, Ed.D.
role: PRINCIPAL_INVESTIGATOR
References: