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临床试验/NCT05762133
NCT05762133已完成不适用

African-American Social Support Effectiveness Treatment-Partners Alleviating Perinatal Depression

Northwestern University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年8月27日最近更新:
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
100
试验地点
2
主要终点
Maternal depression

研究概览

简要总结

The objective of this treatment study is to develop and test an augmentation therapy in conjunction with maternal psychiatric treatment that targets the fathers' support of the mothers' mental health and contributions to the family environment to reduce maternal stress. The African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD) intervention will be delivered to fathers in an individual setting to target the context in which a mother lives to expand her support beyond the direct reach of her treatment professional. This study provides skills and training to fathers who have a partner with prenatal depression. The aim is to reduce maternal depression during the perinatal period and improve the family environment for the infant.

详细描述

African-American (AA) mothers have a higher risk for perinatal depression than Caucasian women that is attributable to increased socio-environmental stressors. In addition, AA women have poor healthcare utilization and compliance with psychiatric treatment compared to Caucasian women. An intervention is required to supplement and support the clinical objectives of the mother's depression care without requiring the mother's direct involvement. Fathers are an underutilized resource to reduce the mother's environmental stress and encourage healthy maternal behaviors. The African-American Social Support Effectiveness Treatment- Partners alleviating Perinatal Depression (ASSET-PPD) protocol will target the fathers' support of the mothers' mental health treatment and their active engagement in the family to reduce maternal stress. The ASSET-PPD intervention will be designed to have 4 active modules that address key factors to reduce maternal stress during the prenatal period and 2 postpartum review sessions. The modules will be individual sessions constructed to provide training, information, and behavioral assignments to increase fathers': 1) prenatal and postpartum family involvement; 2) mental health psychoeducation; 3) interparental communication and relationship skills; and 4) balanced division of family tasks. ASSET-PPD will be evaluated in a pilot Randomized Clinical Trial (RCT) with 50 cohabitating or non-cohabitating fathers and AA mothers who will be randomized into the ASSET-PPD intervention or the comparator group. Fathers only will participate in the intervention, and mothers and fathers will complete measures of mental health and parental experiences. Maternal depressive symptoms will be assessed as a primary outcome, and breastfeeding and parent-infant interactions will be assessed as secondary outcomes.

研究设计

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

盲法说明

At 3- and 6-months postpartum, mothers and fathers will attend an observation that includes a 5-minute free play with their infant separately and a 5-minute free play together as co-parents. Parent-infant interactions will be videotaped and interaction quality will be coded by a blind evaluator.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parents will be 18 years of age or older.
  • Parents are eligible for the study if the woman is in the 2nd trimester, she is receiving psychiatric treatment for depression with a score of 11 or greater on the Inventory of Depressive Symptoms-Self-Rated (IDS-SR16), which indicates clinically significant symptoms, and the mother is African-American
  • Parents do not need to be romantic partners to be eligible. Infants (0-6 months) are included in the study to examine the parent-infant interactions

排除标准

  • The parents will be excluded if:
  • There is report of ongoing physical or sexual abuse
  • They have plans to terminate the pregnancy
  • The woman is showing symptoms of hypomania/mania, psychosis, or substance use in the past 12 months
  • Father will be excluded if he:
  • Has symptoms of psychosis in the past 12 months
  • Has below 6th grade education
  • Has difficulty focusing on 1 hour of instruction

研究组 & 干预措施

No additional treatment group

No Intervention

25 parent dyads with a mother who is receiving individual treatment outside of the study and the father is not receiving the ASSET-PPD training

ASSET-PPD intervention group

Experimental

25 parent dyads with a mother who is receiving individual treatment outside of the study and the father is receiving the ASSET-PPD training

干预措施: African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD) (Behavioral)

结局指标

主要结局

Maternal depression

时间窗: Second trimester through six month postpartum

The Inventory of Depressive Symptoms-Self-Rated (IDS-SR16) is a 16-item self-report measure of depressive symptoms. Minimum value: 0, Maximum value: 3, Higher scores indicate worse outcome

Maternal anxiety

时间窗: Second trimester through six month postpartum

The Generalized Anxiety Disorder-7-item (GAD-7) is a 7-item, self-report measure assesses the dimension of generalized anxiety. Minimum value: 0, Maximum value: 3, Higher scores indicate worse outcome

次要结局

  • Infant affect and mood regulation(Administered at 1-, 3-, and 6-months)
  • Breastfeeding(Administered at 1-, 3-, and 6-months)
  • Parent-infant interaction quality(At 3- and 6-months)

研究者

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

Sheehan David Fisher

Associate Professor

Northwestern University

研究点 (2)

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