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Trial record 24 of 264 for:    Postpartum Depression AND Postpartum Depression | "Depression" AND "Depression"

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

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ClinicalTrials.gov Identifier: NCT02818075
Recruitment Status : Unknown
Verified June 2016 by Barbara Chyzzy, University of Toronto.
Recruitment status was:  Recruiting
First Posted : June 29, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Barbara Chyzzy, University of Toronto

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.

Condition or disease Intervention/treatment Phase
Postpartum Depression Other: Mobile Phone Based Peer Support Other: Usual Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mobile Phone Based Peer Support to Prevent Postpartum Depression Among Adolescent Mothers: A Pilot Randomized Controlled Trial
Study Start Date : April 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mobile Phone Based Peer Support
Mobile phone-based peer support (MPPS)
Other: Mobile Phone Based Peer Support
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.

Other: Usual Care
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.

Active Comparator: Usual Care
Standard community prenatal and postpartum support services
Other: Usual Care
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 Measures :
  1. Feasibility as assessed by the Participant Eligibility Assessment Form [ Time Frame: Through to study completion (12 weeks postpartum) ]
    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).

  2. Acceptability as assessed by the validated Peer Support Evaluation Inventory [ Time Frame: 12 weeks postpartum ]
    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

  3. Compliance as assessed by the Activity Log Form [ Time Frame: Through to study completion (12 weeks postpartum) ]
    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.

  4. Support strategies as assessed by the Activity Log Form [ Time Frame: Through to study completion (12 weeks postpartum) ]
    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 :
  1. Edinburgh Postnatal Depression Scale [ Time Frame: 12 weeks postpartum ]
    To measure depressive symptomatology

  2. State-Trait Anxiety Inventory (STAI) [ Time Frame: 12 weeks postpartum ]
    To measure anxiety levels

  3. Short Form Social Support Questionnaire (SSQ6) [ Time Frame: 12 weeks postpartum ]
    To measure levels of social support since delivery of participant's baby

  4. Health Services Utilization Questionnaire [ Time Frame: 12 weeks postpartum ]
    To collect data on complications during delivery, health service utilization since delivery



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818075


Contacts
Contact: Barbara Chyzzy, RN,PhD(c) 647-292-6521 barbara.chyzzy@utoronto.ca

Locations
Canada, Ontario
University of Toronto Recruiting
Toronto, Ontario, Canada
Contact: Barbara Chyzzy, RN, PhD(c)    647-292-6521      
Principal Investigator: Barbara Chyzzy, RN, PhD(c)         
Sponsors and Collaborators
University of Toronto

Responsible Party: Barbara Chyzzy, PhD Candidate, University of Toronto
ClinicalTrials.gov Identifier: NCT02818075     History of Changes
Other Study ID Numbers: 32189
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Barbara Chyzzy, University of Toronto:
Peer support
Postpartum Depression
Adolescent Pregnancy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications