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临床试验/NCT03282448
NCT03282448已完成不适用

Integrated Video-based Family Therapy for Peripartum Depression in Home Visited Mothers: A Pilot Study

Fallon P. Cluxton-Keller4 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2017年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
4
主要终点
Maternal depressive symptoms

研究概览

简要总结

This pilot study will explore the feasibility and acceptability of implementing a family-based treatment, using HIPAA-compliant video-based communication technology, for adolescents (pregnant and post-delivery) with peripartum depressive symptoms within the context of home visiting.

详细描述

The purpose of the pilot study is to partner with two Federal Maternal, Infant and Early Childhood Home Visiting (HV) Program sites to implement a family-based treatment for depression, using HIPAA-compliant video-based communication technology, in adolescent mothers (pregnant and post-delivery). This implementation-effectiveness hybrid trial includes depressed adolescent mothers and their adult family members.

It has three aims:

  1. Explore the feasibility of integrating the treatment model into two Federal HV Program sites in New Hampshire.
  2. Test the acceptability of the treatment model among depressed adolescent mothers and their families.
  3. Explore preliminary impacts of the treatment on maternal depressive symptoms and parenting attitudes, family emotion regulation, and family functioning at two months post-intervention.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Willingness to participate in the study;
  • Intention to remain in current job for at least 12 months; and
  • Fluency in English: The training, treatment model, implementation meetings, and supervision sessions will be carried out in English.
  • Family Inclusion Criteria:
  • Adolescent mothers, ages 13-25, in the first trimester of pregnancy through eighteen months postpartum;
  • Adolescent mothers with Edinburgh Postnatal Depression Scale scores of ≥8;
  • At least one of the adolescent mother's family members ("family member" is defined as a person she is biologically related to, or significant close others/partners with whom she is not biologically related) must be willing and available to participate in eight of the 10 video-based family therapy sessions;
  • Fluency in English: The treatment will be carried out in English; and
  • Consistent internet access (i.e., subscribe to an internet service provider and do not experience weekly disruptions in service) on a cell phone, tablet, or computer equipped with a camera and microphone.

排除标准

  • Adolescent mothers with
  • A current positive screen for problem alcohol use on the CAGE or TWEAK;
  • A current positive screen on the drug abuse items on the home visiting interview;
  • A current positive screen for domestic violence on the Relationship Assessment Tool;
  • Current hallucinations and/or delusions;
  • Current homicidal ideation;
  • Current suicidal ideation;
  • Current severe major depressive episode as measured by the SCID-V Depression Module for those over age 18, or NIMH DISC-Y & DISC-P Mood Module for those under age 18; and/or
  • Current self-injurious behavior (e.g., cutting arms on a weekly basis). Families with
  • Current Child Protection Service involvement;
  • Current family therapy service involvement; and/or
  • Current or previous Dialectical Behavior Therapy (DBT) treatment.

结局指标

主要结局

Maternal depressive symptoms

时间窗: 5 months

Depressive symptoms will be measured using the Beck Depression Inventory (BDI-II; Beck, Steer, \& Brown, 1996)

次要结局

  • Family Satisfaction(2.5 months)
  • Parenting attitudes(5 months)
  • Therapist-family working alliance(2.5 months)
  • Emotion regulation(5 months)
  • Family functioning(5 months)

研究者

发起方
Fallon P. Cluxton-Keller
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fallon P. Cluxton-Keller

Assistant Professor Psychiatry

Dartmouth-Hitchcock Medical Center

研究点 (4)

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