search
Back to results

Mobile Phone Based Peer Support to Prevent Postpartum Depression Among Adolescent Mothers

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mobile Phone Based Peer Support
Usual Care
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression focused on measuring Peer support, Postpartum Depression, Adolescent Pregnancy

Eligibility Criteria

16 Years - 24 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • > 16 years and < 24 years
  • > 28 weeks gestation (third trimester of pregnancy)
  • Singleton pregnancy
  • Able to speak, read and understand English

Exclusion Criteria:

  • Edinburgh Postnatal Depression Scale (EPDS) score > 12
  • High risk pregnancy (such as placenta previa, placental abruption, unmanaged pre-eclampsia, intrauterine growth restriction, or known fetal abnormality)
  • Current substance use during pregnancy (such as alcohol, cocaine, hallucinogens, marijuana, methadone treatment, narcotics, opioids, etc)
  • Active psychosis, schizophrenia, or bipolar disorder
  • Adolescents who are subject to a Child Protection Order or who are in foster care.

Sites / Locations

  • University of Toronto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile Phone Based Peer Support

Usual Care

Arm Description

Mobile phone-based peer support (MPPS)

Standard community prenatal and postpartum support services

Outcomes

Primary Outcome Measures

Feasibility as assessed by the Participant Eligibility Assessment Form
The Participant Eligibility Assessment Form will be completed by the PI and used to determine 1) recruitment procedures (effectiveness of recruitment approaches, recruitment rate and reasons for non-participation), 2) screening procedures (appropriateness of inclusion and exclusion criteria), and 3) randomization (willingness to be randomized).
Acceptability as assessed by the validated Peer Support Evaluation Inventory
Acceptability will assessed using the validated Peer Support Evaluation Inventory and will describe maternal perspectives of the Mobile Phone Based Peer Support intervention and will be measured at 12 weeks postpartum
Compliance as assessed by the Activity Log Form
Adherence-related measures include 1) the number of first contacts (three-way contact) initiated by the PI between the participant and the peer mentor within 72 hours post randomization; 2) the number of Activity Logs completed electronically by the peer mentor compared to the number of contacts made between the peer mentor and the participant; 3) the degree of intervention fidelity measured by the number of Activity Logs completed in congruence between the PI and peer mentors and 4) the number of participants who complete outcomes measures at 12 weeks postpartum.
Support strategies as assessed by the Activity Log Form
The Activity Log will be used to determine 1) type of support strategies implemented (informational, emotional or appraisal support); 2) type of contact (text-message, voice-call or face to face meeting); 3) dosage (number of voice calls and text messages; duration of contact with peer mentor); 4) technical issues related to the mobile phones and data plans; 5) issues related to participant safety; and 6) whether calls/texts were initiated by the participant or peer mentor intervention is able to be implemented

Secondary Outcome Measures

Edinburgh Postnatal Depression Scale
To measure depressive symptomatology
State-Trait Anxiety Inventory (STAI)
To measure anxiety levels
Short Form Social Support Questionnaire (SSQ6)
To measure levels of social support since delivery of participant's baby
Health Services Utilization Questionnaire
To collect data on complications during delivery, health service utilization since delivery

Full Information

First Posted
June 6, 2016
Last Updated
March 16, 2019
Sponsor
University of Toronto
search

1. Study Identification

Unique Protocol Identification Number
NCT02818075
Brief Title
Mobile Phone Based Peer Support to Prevent Postpartum Depression Among Adolescent Mothers
Official Title
Mobile Phone Based Peer Support to Prevent Postpartum Depression Among Adolescent Mothers: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
January 21, 2018 (Actual)
Study Completion Date
January 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot study will evaluate the feasibility and acceptability of a mobile phone based peer support intervention among adolescent mothers. Half of the participants will receive usual care plus the peer support intervention and the other half of the participants will receive usual care only.
Detailed Description
Postpartum depression (PPD) is one of several postpartum mood disorders and is classified as a major depressive disorder. It has the highest inception rate during the first 12 weeks postpartum and is frequently comorbid with anxiety disorders or significant anxiety symptoms. PPD is the most frequent form of maternal morbidity following childbirth and has serious negative consequences including maternal suffering, impaired maternal-infant interactions and cognitive, behavioural and emotional problems in infants and children. As a result of these negative consequences, PPD has been deemed a major public health concern warranting preventive intervention. Adolescent mothers are a particularly vulnerable maternal population who are at approximately three times greater risk for developing postpartum depression (PPD) compared to adult mothers, with an estimated prevalence of 38%. In 2011, over 65,000 live births were recorded to adolescents between 15-24 years of age in Canada, which represents a significant number of mothers at risk for developing PPD. Several variables have been identified as predictors for PPD among adolescent mothers; however, the one variable which has been consistently identified in studies is a lack of social support. A detailed analysis of social support variables in predictive studies among adolescent mothers clearly identifies not having someone to talk with about their problems as a major deficiency in social support. These findings are not surprising as the relationship between lack of social support and reduced psychological well-being has been well established. Evidence shows that decreased social network size, fewer close relationships, and lower perceived adequacy of social support are all linked to depressive symptomatology. Peer to peer support, a form of social support, has been shown to improve health outcomes in various age groups including adolescents. Peers are lay individuals who have similar characteristics and experiences as a target population and can share pragmatic knowledge and empathic understanding. The provision of peer support includes (a) informational support (knowledge, facts, and suggestions), (b) emotional support (attentive listening, caring and reassurance) and (c) appraisal support (motivation, encouragement and positive communication) which is delivered by a peer. The purpose of this study is to evaluate the feasibility and acceptability of a mobile phone-based peer support intervention and adherence with the trial protocol to inform a future definitive full-scale randomized controlled trial. The design is a pilot randomized controlled trial. Forty eligible and consenting pregnant adolescents age 16-24 years will be randomized into an intervention or control group. Adolescents in the control group will receive standard prenatal and postpartum in-hospital and community care. Adolescents in the intervention group will receive the same standard care as the control group plus a mobile phone-based peer support intervention. Mobile phone-based peer support will consist of support provided by a trained peer mentor starting in the participant's last trimester of pregnancy and continuing for 12 weeks postpartum. Peer mentors are young mothers between 16-24 years of age who will receive 12 hours of training to learn how to provide support to new young mothers. Peer support will be provided either via voice calling or text messaging depending on the participant's preference. Additionally, acceptability by participants the intervention group will be evaluated via questionnaire and semi-structured interview to determine likes/dislikes and areas for improvement. Preliminary effectiveness will be a secondary outcome with depressive and anxiety symptoms measured using the Edinburgh Postnatal Depression Scale and the Speilberger State Anxiety Inventory at 12 weeks postpartum. Social support and health services utilization will also be measured at 12 weeks postpartum. This study will provide evidence about a novel approach to preventing PPD among adolescent mothers. Results will reveal which components of peer support (informational, emotional or appraisal support) and which aspects of mobile phone technology (voice-calling, text messaging or a combination of both) are most acceptable for adolescent mothers. Based on the results of this current study, new knowledge will be gained in relation to the provision of peer support among adolescent mothers using mobile technology. This trial will provide valuable information to address a major public health concern (PPD) in a highly vulnerable population (adolescent mothers).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Peer support, Postpartum Depression, Adolescent Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Phone Based Peer Support
Arm Type
Experimental
Arm Description
Mobile phone-based peer support (MPPS)
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Standard community prenatal and postpartum support services
Intervention Type
Other
Intervention Name(s)
Mobile Phone Based Peer Support
Intervention Description
Adolescents allocated to the experimental group will have access to all standard prenatal and postpartum community supports. In addition, mobile phone-based peer support (MPPS), which consists of support provided by a peer mentor via mobile phone (with both voice calling and Short Message Service text message capabilities) will be provided during pregnancy and for 12 weeks postpartum. Peer support is defined as a specific type of social support (informational, appraisal, and emotional support) that is provided by a peer mentor who possesses experiential knowledge of adolescent motherhood and is of similar age to the participant.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Participants allocated to the usual care group will not receive the peer support intervention but will have access to all standard community prenatal and postpartum support services such as 1) the Canada Prenatal Nutrition Program; 2) postpartum home visits / telephone support from a public health nurse; 3) postpartum appointments with midwives, obstetrician, family physician, and / or pediatricians, and 4) prenatal and postpartum support as needed from psychiatrists, psychologists, social workers, breastfeeding clinics, and community resources.
Primary Outcome Measure Information:
Title
Feasibility as assessed by the Participant Eligibility Assessment Form
Description
The Participant Eligibility Assessment Form will be completed by the PI and used to determine 1) recruitment procedures (effectiveness of recruitment approaches, recruitment rate and reasons for non-participation), 2) screening procedures (appropriateness of inclusion and exclusion criteria), and 3) randomization (willingness to be randomized).
Time Frame
Through to study completion (12 weeks postpartum)
Title
Acceptability as assessed by the validated Peer Support Evaluation Inventory
Description
Acceptability will assessed using the validated Peer Support Evaluation Inventory and will describe maternal perspectives of the Mobile Phone Based Peer Support intervention and will be measured at 12 weeks postpartum
Time Frame
12 weeks postpartum
Title
Compliance as assessed by the Activity Log Form
Description
Adherence-related measures include 1) the number of first contacts (three-way contact) initiated by the PI between the participant and the peer mentor within 72 hours post randomization; 2) the number of Activity Logs completed electronically by the peer mentor compared to the number of contacts made between the peer mentor and the participant; 3) the degree of intervention fidelity measured by the number of Activity Logs completed in congruence between the PI and peer mentors and 4) the number of participants who complete outcomes measures at 12 weeks postpartum.
Time Frame
Through to study completion (12 weeks postpartum)
Title
Support strategies as assessed by the Activity Log Form
Description
The Activity Log will be used to determine 1) type of support strategies implemented (informational, emotional or appraisal support); 2) type of contact (text-message, voice-call or face to face meeting); 3) dosage (number of voice calls and text messages; duration of contact with peer mentor); 4) technical issues related to the mobile phones and data plans; 5) issues related to participant safety; and 6) whether calls/texts were initiated by the participant or peer mentor intervention is able to be implemented
Time Frame
Through to study completion (12 weeks postpartum)
Secondary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale
Description
To measure depressive symptomatology
Time Frame
12 weeks postpartum
Title
State-Trait Anxiety Inventory (STAI)
Description
To measure anxiety levels
Time Frame
12 weeks postpartum
Title
Short Form Social Support Questionnaire (SSQ6)
Description
To measure levels of social support since delivery of participant's baby
Time Frame
12 weeks postpartum
Title
Health Services Utilization Questionnaire
Description
To collect data on complications during delivery, health service utilization since delivery
Time Frame
12 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: > 16 years and < 24 years > 28 weeks gestation (third trimester of pregnancy) Singleton pregnancy Able to speak, read and understand English Exclusion Criteria: Edinburgh Postnatal Depression Scale (EPDS) score > 12 High risk pregnancy (such as placenta previa, placental abruption, unmanaged pre-eclampsia, intrauterine growth restriction, or known fetal abnormality) Current substance use during pregnancy (such as alcohol, cocaine, hallucinogens, marijuana, methadone treatment, narcotics, opioids, etc) Active psychosis, schizophrenia, or bipolar disorder Adolescents who are subject to a Child Protection Order or who are in foster care.
Facility Information:
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mobile Phone Based Peer Support to Prevent Postpartum Depression Among Adolescent Mothers

We'll reach out to this number within 24 hrs