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临床试验/NCT03212339
NCT03212339撤回不适用

Project BELONG: Breaking the Cycle of Intergenerational Family Violence and Trauma: Innovating, Expanding and Sustaining Treatment for Caregivers and Very Young Children

Boston Medical Center2 个研究点 分布在 1 个国家开始时间: 2018年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Parent-child interaction

研究概览

简要总结

This study will examine the efficacy of a dyadic therapy intervention for mothers who have histories of adverse events (e.g., history of family violence, partner violence, family conflict, and/or childhood trauma, including abuse/neglect) and their very young children (ages 0-5 years), with the goal of demonstrating how an evidence supported, community-based and/or hospital-based therapeutic intervention may help reduce exposure to trauma and incidents of child maltreatment, improve parental stress and mental health, and secure parent-child attachment.

The three main objectives associated with Project BELONG are: 1) to determine the effectiveness of a dyadic care model in improving parent/child interaction, parenting confidence and competence, reducing parenting stress and social isolation, and improving access to concrete supports; 2) to address maltreatment risk in children by enhancing social-emotional functioning and developmental progress; and 3) to train new and future mental health professionals in dyadic mental health services and disseminate the model and findings through health professional schools and publications.

详细描述

A maximum of ninety (N=90) women and children will be screened and recruited from three clinical care programs at Boston Medical Center (BMC): 1) the SPARK Center, 2) Child Witness to Violence, and 3) Project RESPECT, to participate in therapeutic programming delivered by trained psychologists, social workers and therapists at the SPARK Center in Mattapan, MA or at Child Witness to Violence at BMC in Boston, MA. Mothers with children through the age of 3 years will be attending modified Group Attachment Based Intervention (mGABI) sessions at the SPARK Center that will include a small group of other mother-child pairs and approximately two therapists. Mothers with children between the ages of 3 and 5 years will be attending Brief Dyadic Intervention (BDI) sessions at Child Witness to Violence and/or the SPARK Center with their child and an individual therapist. The therapeutic interventions will be similar between the two groups and will be delivered in 10 sessions over the course of approximately 12-15 weeks. Each session will be approximately 2 hours long and will be scheduled to accommodate the participants' schedules. Participants will be asked to attend 1 session per week and to participate in two research data collection sessions that are part of the 10-session commitment. The first session will occur at the beginning of the study (pre-intervention) and the second session will occur at the end of the study (post-intervention). During the first data collection session, participants will be asked to provide demographic information and complete interviews about past experiences and current experiences as a parent, and their child's current functioning. Parents will also be video recorded interacting with their child for 10 minutes. During the second data collection session, participants will be asked to complete a similar set of interviews and they will be video recorded again interacting with their child for 10 minutes.

Project BELONG will address the impact of trauma and dyadic therapy on the mother and child as it affects parenting, child development, and child behavior. Changes in parents' ability to interact with their child in nurturing and responsive ways (as measured by coding videotapes of pre- and post- mother-child interactions) will be investigated as well as improvements in maternal symptoms of stress, depression and feelings of self-efficacy (as measured by validated, evidence-based pre- and post- assessments). Child outcomes will be assessed via change from baseline in measures of child's psychosocial functioning and development.

研究设计

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

入排标准

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

入选标准

  • Female gender
  • 18 years of age or older
  • Has a child under the age of 5 years
  • Must be parent or legal guardian of child
  • Comfortable communicating in English
  • Plan to stay in the greater Boston area for the next 6 months [post IRB-approval]
  • Typically available between the hours of 8:00 AM and 5:00 PM at least one day during the week (Monday thru Friday)
  • Must answer "yes" to having experienced hardships in their own life, which may have involved any of the following: threat of violence, family violence, partner violence, family conflict, and/or mistreatment in their own childhood.
  • Must be able to provide informed consent

排除标准

  • Child previously diagnosed with autism, severe global delay, blindness, deafness or paralysis

研究组 & 干预措施

Mothers with children <3 years of age

Experimental

Dyads of mothers with children up to 3 years of age will be attending modified Group Attachment Based Intervention (mGABI) sessions at the SPARK Center that will include a small group of other mother-child pairs and approximately two therapists. Dyads will be offered the 10 session therapeutic intervention.

干预措施: Therapeutic intervention (Other)

Mothers with children 3-5 years of age

Experimental

Dyads of mothers with children between the ages of 3 and 5 years will be attending Brief Dyadic Intervention (BDI) sessions at Child Witness to Violence and/or the SPARK Center with their child and an individual therapist. Dyads will be offered the 10 session therapeutic intervention.

干预措施: Therapeutic intervention (Other)

结局指标

主要结局

Parent-child interaction

时间窗: Change from baseline and 14 weeks

Parent-child interactions will be assessed from the 10-minute video recordings of naturalistic interaction between parent and child using the Coding Interactive Behavior (CIB) global rating system. The CIB assesses parent, child and dyadic affective states and interactive styles to measure social behavior. It includes multiple scales (ranging from 34 to 52 depending on age) organized into several composites that index important aspects of any relationship, such as sensitivity, intrusiveness, engagement, reciprocity.

次要结局

  • Parenting stress(Change from baseline and 14 weeks)
  • Parental distress and depression(Change from baseline and 14 weeks)
  • Parental reflective functioning(Change from baseline and 14 weeks)
  • Material hardships(Change from baseline and 14 weeks)
  • Parental perceptions of infant/child development(Change from baseline and 14 weeks)
  • Parental concern of child development(week 1)
  • Parental childhood experiences of abuse and neglect(week 1)
  • Parenting satisfaction and efficacy(Change from baseline and 14 weeks)
  • Interviewer-observed parent-child interaction(Change from baseline and 14 weeks)
  • Child social and emotional skills and competencies(Change from baseline and 14 weeks)

研究者

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

Neena McConnico

Program Director, Child Witness to Violence Project

Boston Medical Center

研究点 (2)

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