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

NCT02818075 | Completed

• 1 other identifier: 32189
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Keywords

Peer support; Postpartum Depression; Adolescent Pregnancy

Outcome Measures

Primary Outcomes (4)

• 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).

  Through to study completion (12 weeks postpartum)

• 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

  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.

  Through to study completion (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

  Through to study completion (12 weeks postpartum)

Secondary Outcomes (4)

• Edinburgh Postnatal Depression Scale

  12 weeks postpartum

• State-Trait Anxiety Inventory (STAI)

  12 weeks postpartum

• Short Form Social Support Questionnaire (SSQ6)

  12 weeks postpartum

• Health Services Utilization Questionnaire

  12 weeks postpartum

Study Arms (2)

Mobile Phone Based Peer Support

EXPERIMENTAL

Mobile phone-based peer support (MPPS)

Other: Mobile Phone Based Peer Support; Other: Usual Care

Usual Care

ACTIVE COMPARATOR

Standard community prenatal and postpartum support services

Other: Usual Care

Interventions

Mobile Phone Based Peer Support OTHER

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.

Mobile Phone Based Peer Support

Usual Care OTHER

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.

Mobile Phone Based Peer Support; Usual Care

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

University of Toronto

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 29, 2016
• Study Start: April 1, 2016
• Primary Completion: January 21, 2018
• Study Completion: January 21, 2018
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)