Postpartum Depression Clinical Trial
Official title:
Mobile Phone Based Peer Support to Prevent Postpartum Depression Among Adolescent Mothers: A Pilot Randomized Controlled Trial
NCT number | NCT02818075 |
Other study ID # | 32189 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | January 21, 2018 |
Verified date | March 2019 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 21, 2018 |
Est. primary completion date | January 21, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 24 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Toronto | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | |
Primary | 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) | |
Primary | 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 | Edinburgh Postnatal Depression Scale | To measure depressive symptomatology | 12 weeks postpartum | |
Secondary | State-Trait Anxiety Inventory (STAI) | To measure anxiety levels | 12 weeks postpartum | |
Secondary | Short Form Social Support Questionnaire (SSQ6) | To measure levels of social support since delivery of participant's baby | 12 weeks postpartum | |
Secondary | Health Services Utilization Questionnaire | To collect data on complications during delivery, health service utilization since delivery | 12 weeks postpartum |
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