Postpartum DepressionNCT02818075
Mobile Phone Based Peer Support to Prevent Postpartum Depression Among Adolescent Mothers
A study testing Mobile Phone Based Peer Support in people with Postpartum Depression, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Mobile Phone Based Peer Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to 21 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- > 16 years and < 24 years
- > 28 weeks gestation (third trimester of pregnancy)
- Singleton pregnancy
- Able to speak, read and understand English
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile Phone Based Peer Support to Prevent Postpartum Depression Among Adolescent Mothers: A Pilot Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Postpartum Depression
- Being tested
- Mobile Phone Based Peer Support, Usual Care
- Keywords
- Peer support, Postpartum Depression, Adolescent Pregnancy
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Phone Based Peer SupportOther
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Phone Based Peer Support | Experimental | Mobile phone-based peer support (MPPS) Receives: Other: Mobile Phone Based Peer Support; Other: Usual Care |
| Usual Care | Active comparator | Standard community prenatal and postpartum support services Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 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
Measured: Through to study completion (12 weeks postpartum)
Secondary outcomes (4)
Edinburgh Postnatal Depression Scale
To measure depressive symptomatology
Measured: 12 weeks postpartum
State-Trait Anxiety Inventory (STAI)
To measure anxiety levels
Measured: 12 weeks postpartum
Short Form Social Support Questionnaire (SSQ6)
To measure levels of social support since delivery of participant's baby
Measured: 12 weeks postpartum
Health Services Utilization Questionnaire
To collect data on complications during delivery, health service utilization since delivery
Measured: 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startApr 2016
- Primary completion21 Jan 2018
- Study completion21 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Chyzzy, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818075
- Sponsor's protocol ID
- 32189
- Status last verified
- Mar 2019
- First submitted
- 6 Jun 2016
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone Based Peer Support to Prevent Postpartum Depression Among Adolescent Mothers: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02818075
- Acronym / sponsor ID
- 32189
- Conditions
- Postpartum Depression
- Keywords
- Peer support, Postpartum Depression, Adolescent Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 21 Jan 2018 (actual)
- Study completion
- 21 Jan 2018 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Phone Based Peer Support | Experimental | Other: Mobile Phone Based Peer Support, Other: Usual CareMobile phone-based peer support (MPPS) |
| Usual Care | Active comparator | Other: Usual CareStandard community prenatal and postpartum support services |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- > 16 years and < 24 years
- > 28 weeks gestation (third trimester of pregnancy)
- Singleton pregnancy
- Able to speak, read and understand English
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Phone Based Peer SupportAdolescents 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 | Mobile Phone Based Peer Support |
| Usual CareParticipants 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. | Other | Mobile Phone Based Peer Support, Usual Care |
Primary outcome
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).
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
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.
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
4 secondary outcomes
Edinburgh Postnatal Depression Scale
Time frame: 12 weeks postpartum
State-Trait Anxiety Inventory (STAI)
Time frame: 12 weeks postpartum
Short Form Social Support Questionnaire (SSQ6)
Time frame: 12 weeks postpartum
Health Services Utilization Questionnaire
Time frame: 12 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Phone Based Peer Support in people with Postpartum Depression, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by the Participant Eligibility Assessment Form (time frame: Through to study completion (12 weeks postpartum)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.