NCT07380061

Brief Summary

This study tested whether a peer mentor text message program (called the Nurture program) could help support mental health during pregnancy and after birth. In the study, 127 pregnant people in Washington state were randomly placed to in one of two groups: Nurture group - could text with a trained peer mentor and Control group got automated informational text messages. Researchers looked at how much participants used the program and whether it affected symptoms of depression, anxiety and stress related to parenting. Most people in the Nurture group actively used the program. Nearly all responded to their mentor and there was an average of 32 back and forth text conversations. Mentors usually started more conversations than participants did. People using Nurture had lower anxiety six weeks after giving birth compared to the control group. However there were no statistically significant differences between the two groups for depression or parenting stress. The findings suggest that having two way text conversations with peer mentors is well received and may help reduce anxiety soon after birth. More research with larger groups is needed to understand the full benefits and how to make the program widely available.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 6, 2026

Last Update Submit

January 23, 2026

Conditions

Keywords

perinatal mental healthtext messagingpeer support

Outcome Measures

Primary Outcomes (5)

  • Change from baseline in depressive symptoms over time as measured by the PHQ-9

    Depressive symptoms in pregnancy and postpartum measured using the Patient Health Questionnaire -9 (PHQ-9). Score range 0 to 27, with higher scores meaning worse depression.

    Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.

  • Change from baseline in anxiety symptoms over time, as measured by GAD-7.

    Anxiety during pregnancy and postpartum, measured using the Generalized Anxiety disorder Scale (GAD-7). Score range from 0 to 27 with higher scores meaning worse anxiety

    Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.

  • Change from baseline to 9 months in Parenting Stress as measured by the Parenting Stress Scale

    Parenting Stress measured using the Parenting Stress Scale. An 18 - item self report scale - items represent positive (e.g. emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. Overall possible scores on the scale range from 18 - 90. The higher the score , the higher the measured level of Parental stress

    6 weeks and 9 months postpartum.

  • Feasibility of enrolment as measured by number of participants enrolled

    Ability to enroll into the study

    Baseline

  • Intervention engagement as measured by number of messages exchanged

    Engagement measured by number of messages exchanged

    Baseline, 9 months postpartum

Secondary Outcomes (4)

  • Change from baseline in General Wellbeing over time as measured by the General Wellbeing Schedule

    Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.

  • Change in Maternal self efficacy from baseline over time as measures by the Self Efficacy in a Nurturing Role questionnaire.

    Baseline, 6 weeks and 9 months postpartum.

  • Change in wellbeing from baseline to 9 months as measured by the Flourishing scale

    Baseline and 9 months postpartum.

  • Social support

    Baseline, 3 months and 9 months postpartum.

Study Arms (2)

Intervention

ACTIVE COMPARATOR

If assigned to Nurture (intervention arm), the participant was matched with a mentor from Nurture based on participants responses in their intake form which asked if there was anything in particular that they wanted support with and if there were characteristics that were important to them to share with their mentor. The mentor sent weekly messages based on a library of prompts. Prompts provided resources on child development, connections to local support agencies, and suggestions for parent-child bonding and parental wellness activities.

Behavioral: Peer mentor texting

Control

ACTIVE COMPARATOR

Participants receive automated interventional texts

Behavioral: Control

Interventions

ControlBEHAVIORAL

If assigned to the control arm, the participant received automated informational texts throughout the period of participation. Participants could not respond to these texts. Information content that is publicly available such as the Babycenter's pregnancy stage information the Washington State Department of Children, Youth, and Families (DCYF) information packets about infant development and milestones as well as various ways to encourage learning and healthy development was used.

Control

If assigned to Nurture (intervention arm), the participant was matched with a mentor from Nurture based on participants responses in their intake form which asked if there was anything in particular that they wanted support with and if there were characteristics that were important to them to share with their mentor. The mentor sent weekly messages based on a library of prompts. Prompts provided resources on child development, connections to local support agencies, and suggestions for parent-child bonding and parental wellness activities.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women and other birthing individuals receiving prenatal care within Washington.

You may not qualify if:

  • Severe mental illness such as bipolar disorder and schizophrenia and severe substance use disorder based on self report.
  • Severe depression symptomology operationalized as PHQ-9 score 20 or higher.
  • Severe suicidality (a response of "Nearly every day" to question 9, "Over the last 2 weeks, how often have you been bothered by any of the following problems?: Thoughts that you would be better off dead or of hurting yourself in some way." on the PHQ-9 questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 6, 2026

First Posted

February 2, 2026

Study Start

January 12, 2022

Primary Completion

May 4, 2023

Study Completion

May 4, 2023

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations