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

NCT03497286 | Completed

• 1 other identifier: PRO17090518
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Mothers

Keywords

maternal health; maternal stress; infant health

Outcome Measures

Primary Outcomes (2)

• Parental Stress

  We will measure parental stress using self-administered subscales from the parent domain of the Parenting Stress Index (4th Edition): isolation, attachment, depression, child reinforces parent, and parent competence (15 minutes; Abidin, 2012). As we are omitting subscales that are not of interest, we cannot generate an overall score. Each subscale can be scored individually. Each subscale has a number of items scored 1 (strongly disagree) to 5 (strongly agree). The number of items per subscale and therefore the subscale score ranges vary. The ranges for each subscale are as follows: isolation (6-30), attachment (7-35), depression (9-45), child reinforces parent (6-30), and parent competence (11-55). Subscale scores are calculated by summing each of the responses that correspond with the subscale. Higher scores indicate higher levels of stress, which is considered to be a worse outcome. Percentile scores corresponding to each of the subscale raw scores are also available.

  4 months from study start

• Parental stress

  We will measure parental stress at 18 months from study start using two of three self-administered subscales of the Parenting Stress Index Short Form (Fourth Edition): parental distress and parent-child dysfunctional interaction (10 minutes; Abidin, 2012). We will be reporting individual measurements, rather than change over time. As we are omitting subscales that are not of interest to our project, we cannot generate an overall score for the parent domain. However, each subscale can be scored individually. Each subscale has a number of items scored 1 (strongly disagree) to 5 (strongly agree). Each subscale has 12 items and thus score ranges of 12-60. Subscale scores are calculated by summing each of the responses that correspond with the subscale. Higher scores indicate higher levels of stress, which is considered to be a worse outcome. Percentile scores corresponding to each of the subscale raw scores are also available.

  18 months from study start

Secondary Outcomes (8)

• Maternal Knowledge

  4 months from study start

• Engagement in Language and Literacy Activities

  4 months from study start

• Engagement in Language and Literacy Activities

  18 months from study start

• Child Development

  4 months from study start

• Child Development

  18 months from study start

Study Arms (2)

Treatment

EXPERIMENTAL

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.

Behavioral: Text-based mentorship

Control

ACTIVE COMPARATOR

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

Behavioral: Control text messaging

Interventions

Text-based mentorship 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.

Treatment

Control text messaging BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): collaborator
• University of Michigan: collaborator

Study Sites (1)

West Penn Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Links

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

Study Officials

• Lindsay C Page, Ed.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Christina Weiland, Ed.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 13, 2018
• Study Start: May 9, 2018
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available for request upon publication of results from this study.
• Access Criteria: Interested researchers will need to seek permission through the clinical site IRB and the study PI. Interested researchers will need to enter into a data use agreement with the Allegheny-Singer Research Institute.

Locations

US (1)