MothersNPANCT03497286
Virtual Mentorship to Support Maternal and Infant Health and Wellbeing: Assessing the Impact and Efficacy of NurturePA
A study testing Text-based mentorship in people with Mothers, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mothers
- What is being tested?
- Text-based mentorship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2018to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- History of substance abuse disorder
- Parents/guardians who, in the opinion of the Investigator, may be non-adherent with study schedules or procedures.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mothers
- Being tested
- Text-based mentorship, Control text messaging
- Keywords
- maternal health, maternal stress, infant health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text-based mentorshipBehavioural
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 text messagingBehavioural
Control participants will receive periodic texts from NurturePA with information about child safety and health.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months from study start
Secondary outcomes (8)
Maternal Knowledge
We will adapt the Opinions about Babies questionnaire which was developed by Stephanie Reich as a criterion-referenced knowledge questionnaire for use in a 2005 study (Reich, 2005). The content comes from the Bright Futures Guidelines for Health Supervision, and the American Academy of Pediatrics Guidelines for Health Supervision III (Reich, 2005). It has been used to measure the effects of an educational baby book intervention on maternal knowledge and was shown to be sensitive to intervention effects (Reich et al, 2010). Under the advisement of NurturePA, we selected items that target the types of developmental and self-care knowledge that the program aims to impart. We also edited the wording of some items to more closely target these topics of interest. The edited questionnaire includes 11true/false items. Items are scored 0 if incorrect and 1 if correct and then the items are summed resulting in a final score between 0 and 11. A higher score indicates a better outcome.
Measured: 4 months from study start
Engagement in Language and Literacy Activities
We will measure the mother's level of engagement in activities that support the development of their child's language and literacy activities at 4 months after study start using a self-administered questionnaire. We will report individual scores rather than change over time. The items on the questionnaire are drawn from three sources. Many of the items are taken from a survey administered during the Metro Baby Study, a longitudinal study of low-income minority families in New York City conducted by The Center for Research on Culture, Development, and Education at New York University. Additional items were added based on items from Early Head Start parent surveys and the Ages and Stages 12-month questionnaire (Squires \& Bricker, 2009). The 4-month measure will include 8 items scored from 1 (rarely/not at all) to 4 (every day) for a total score range of 8 to 32 where higher scores indicate a better outcome.
Measured: 4 months from study start
Engagement in Language and Literacy Activities
We will measure the mother's level of engagement in activities that support the development of their child's language and literacy activities at 18 months after study start using a self-administered questionnaire. We will report individual scores rather than change over time. The items on the questionnaire are drawn from three sources. Many of the items are taken from a survey administered during the Metro Baby Study, a longitudinal study of low-income minority families in New York City conducted by The Center for Research on Culture, Development, and Education at New York University. Additional items were added based on items from Early Head Start parent surveys and the Ages and Stages 12-month questionnaire (Squires \& Bricker, 2009). The 18-month measure will include 11 items scored from 1 (rarely/not at all) to 4 (every day) for a total score range of 11 to 44 where higher scores indicate a better outcome.
Measured: 18 months from study start
Child Development
We will measure child development at 4 months after study start using a self-administered questionnaire asking mothers to report whether their baby has reached particular developmental milestones. We will report individual scores rather than change over time. At 4 months after study start the questionnaire will include 5 items scored from 1 (not yet) to 3 (yes) for a total score range of 5 to 15 where higher scores indicate a better outcome.
Measured: 4 months from study start
Child Development
We will measure child development at 18 months after study start using a self-administered questionnaire asking mothers to report whether their baby has reached particular developmental milestones. We will report individual scores rather than change over time. At 18 months after study start the questionnaire will include 10 items scored from 1 (not yet) to 3 (yes) for a total score range of 10 to 30 where higher scores indicate a better outcome.
Measured: 18 months from study start
WIC Usage
We will measure WIC usage at 4 months after study start and 18 months after study start by using data from the Allegheny County Integrated Data Systems. WIC usage will be measured in the length of time receiving WIC benefits.
Measured: 4 and 18 months from study start
Early Language and Development Screening
We will measure usage of early language and development screening services 4 months after study start and 18 months after study start by using data from the Allegheny County Integrated Data Systems. Screening usage will be measured with a binary indicator of whether or not a mother has used screening services.
Measured: 4 and 18 months from study start
Edinburgh Postnatal Depression Scale
This is a 10-question self-rating scale for assessing perinatal depression. The scale is administered at approximately 4 months post-partum during the course of a well-baby doctor's office visit. Each of the 10 items is scaled on a 0-3 scale and then these item scores are summed for an overall score. Overall scores are interpreted as follows: 0-8 (low probability of depression); 8-12 (most likely just dealing with a new baby or the baby blues); 13-14 (signs leading to possibility of post-partum depression); 15+ (high probability of experiencing clinical depression).
Measured: 4 months from start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start9 May 2018
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MothersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), University of Michigan
- Responsible party
- Principal investigator, Lindsay Page, University of Pittsburgh
- Investigators
- Lindsay C Page, Ed.D., Principal investigator, University of PittsburghChristina Weiland, Ed.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497286
- Sponsor's protocol ID
- PRO17090518
- Acronym
- NPA
- Status last verified
- Aug 2021
- First submitted
- 6 Apr 2018
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A full de-identified participant level data file will be available for future studies.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Mentorship to Support Maternal and Infant Health and Wellbeing: Assessing the Impact and Efficacy of NurturePA
- ClinicalTrials.gov ID
- NCT03497286
- Acronym / sponsor ID
- NPA / PRO17090518
- Conditions
- Mothers
- Keywords
- maternal health, maternal stress, infant health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), University of Michigan
- Study start
- 9 May 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Text-based mentorshipParticipants 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. |
| Control | Active comparator | Behavioral: Control text messagingParticipants in the control condition will receive periodic informational texts related to the growth and development of their new baby. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (2 listed)
- History of substance abuse disorder
- Parents/guardians who, in the opinion of the Investigator, may be non-adherent with study schedules or procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text-based mentorshipThe 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. | Behavioural | Treatment |
| Control text messagingControl participants will receive periodic texts from NurturePA with information about child safety and health. | Behavioural | Control |
Primary outcome
Parental Stress
Time frame: 4 months from study start
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.
Parental stress
Time frame: 18 months from study start
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.
8 secondary outcomes
Maternal Knowledge
Time frame: 4 months from study start
Engagement in Language and Literacy Activities
Time frame: 4 months from study start
Engagement in Language and Literacy Activities
Time frame: 18 months from study start
Child Development
Time frame: 4 months from study start
Child Development
Time frame: 18 months from study start
WIC Usage
Time frame: 4 and 18 months from study start
Early Language and Development Screening
Time frame: 4 and 18 months from study start
Edinburgh Postnatal Depression Scale
Time frame: 4 months from start of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- NurturePA is the non-profit organization which runs the text-based mentorship program for new mothers that we are investigating.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. A full de-identified participant level data file will be available for future studies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay C Page, Ed.D. principal investigator
University of Pittsburgh
Christina Weiland, Ed.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text-based mentorship in people with Mothers, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Stress (time frame: 4 months from study start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.