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临床试验/NCT02818075
NCT02818075已完成不适用

Mobile Phone Based Peer Support to Prevent Postpartum Depression Among Adolescent Mothers: A Pilot Randomized Controlled Trial

University of Toronto1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Feasibility as assessed by the Participant Eligibility Assessment Form

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 24 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Mobile Phone Based Peer Support

Experimental

Mobile phone-based peer support (MPPS)

干预措施: Usual Care (Other)

Mobile Phone Based Peer Support

Experimental

Mobile phone-based peer support (MPPS)

干预措施: Mobile Phone Based Peer Support (Other)

Usual Care

Active Comparator

Standard community prenatal and postpartum support services

干预措施: Usual Care (Other)

结局指标

主要结局

Feasibility as assessed by the Participant Eligibility Assessment Form

时间窗: 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).

Compliance as assessed by the Activity Log Form

时间窗: 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.

Acceptability as assessed by the validated Peer Support Evaluation Inventory

时间窗: 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

Support strategies as assessed by the Activity Log Form

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara Chyzzy

PhD Candidate

University of Toronto

研究点 (1)

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