Peer Mentor Texting
Feasibility and Preliminary Effectiveness of a Bidirectional Peer - Mentor Text Messaging Intervention to Promote Perinatal Mental Health: A Pilot Randomized Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women and other birthing individuals receiving prenatal care within Washington.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Intervention
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.
|
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.
|
|
Active Comparator: Control
Participants receive automated interventional texts
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in depressive symptoms over time as measured by the PHQ-9
Time Frame: Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.
|
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.
Time Frame: Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.
|
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
Time Frame: 6 weeks and 9 months postpartum.
|
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
Time Frame: Baseline
|
Ability to enroll into the study
|
Baseline
|
|
Intervention engagement as measured by number of messages exchanged
Time Frame: Baseline, 9 months postpartum
|
Engagement measured by number of messages exchanged
|
Baseline, 9 months postpartum
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in General Wellbeing over time as measured by the General Wellbeing Schedule
Time Frame: Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.
|
Measure of wellbeing, score range 0 - 110, higher scores indicating higher wellbeing.
|
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.
Time Frame: Baseline, 6 weeks and 9 months postpartum.
|
Parenting self efficacy measured during pregnancy and postpartum, using the Self Efficacy in a Nurturing Role questionnaire.16 items, score range 16 - 112, higher scores represent higher self efficacy.
|
Baseline, 6 weeks and 9 months postpartum.
|
|
Change in wellbeing from baseline to 9 months as measured by the Flourishing scale
Time Frame: Baseline and 9 months postpartum.
|
Measure of wellbeing.
Score range is 8 to 56, with higher scores representing a person with many psychological resources and strengths.
|
Baseline and 9 months postpartum.
|
|
Social support
Time Frame: Baseline, 3 months and 9 months postpartum.
|
Social support measured using Multidimensional scale of perceived social support (MSPSS). The MSPSS a 12-item self-report questionnaire that measures perceived support from family, friends, and significant others. Score Range 12 to 84, low scores indicating low support and high scores indicating high support. |
Baseline, 3 months and 9 months postpartum.
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- STUDY00013616
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.