跳至主要内容
临床试验/NCT05400434
NCT05400434
招募中
不适用

The Development and Implementation of a Natural Helpers Program to Increase the Recruitment, Retention, and Engagement of Underserved Families in Parent-Child Interaction Therapy (PCIT)

University of Miami4 个研究点 分布在 1 个国家目标入组 300 人2018年12月3日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Child Behavior
发起方
University of Miami
入组人数
300
试验地点
4
主要终点
Parenting Stress as measured by Parenting Stress Index Short Form (PSI-SF-4)
状态
招募中
最后更新
3个月前

概览

简要总结

The purpose of the study is to evaluate the effect of a time-limited (i.e., 18 weeks) community health worker (CHW) intervention, referred to as the Parent Child Interaction Therapy (PCIT) plus natural helper (NH) model, on treatment engagement, retention, and child and caregiver outcomes.

注册库
clinicaltrials.gov
开始日期
2018年12月3日
结束日期
2026年12月27日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Jason Jent

Associate Professor

University of Miami

入排标准

入选标准

  • Families of children 2 years of age to 12 years of age.
  • Children 2 to 7 years of age with a history of child abuse or neglect and/or child behavior problems or children ages 8 years to 12 years of age with history of or risk for abuse and the child does not exhibit clinically significant behavior problems.
  • At the time of enrollment, participants must agree that, within the upcoming six months, they will not move away to a location where they would no longer be able to regularly attend weekly sessions (i.e., moving out of Miami Dade County).

排除标准

  • Families with child younger than 2 years of age or older than 7 years of age with clinically significant behavior problems
  • Adults who are unable to consent and prisoners

结局指标

主要结局

Parenting Stress as measured by Parenting Stress Index Short Form (PSI-SF-4)

时间窗: Up to 26 weeks

The PSI-SF-4 is a 36-item self-report questionnaire used to measure caregiver stress and difficulties in the caregiver-child relationship for caregivers of youth between ages 0-12. The PSI-SF-4 yields a Total Stress percentile score (0-100) with higher scores indicating higher stress.

Child externalizing behavior as measured by ECBI Intensity Scale

时间窗: Up to 26 weeks

The Eyberg Child Behavior Inventory (ECBI) is a 36-item caregiver report measure of disruptive behaviors in children ages 2-16 . The Intensity Scale assesses the frequency of behavior problems (1=never to 7=always) with total scores ranging from 36 to 252. A raw score of 131 or higher on the Intensity Scale is considered clinically significant child externalizing behavior.

Family cohesion as measured by Bloom's Family Processes Scale

时间窗: Up to 26 weeks

The Bloom's Family Processes Scale assesses family cohesion using a 5-item cohesion subscale (e.g., "there is a feeling of togetherness in our family"). Caregivers rate their level of agreement on a five-point Likert scale (1=strongly agree to 5=strongly disagree). Total score ranges from 5-25 with the higher scores indicating greater cohesion.

Child externalizing behavior as measured by ECBI Problem Scale

时间窗: Up to 26 weeks

The Eyberg Child Behavior Inventory (ECBI) is a 36-item caregiver report measure of disruptive behaviors in children ages 2-16 . The Problem Scale assesses caregiver perceived behavior problems (1 = yes, 0 = no) with total scores ranging from 0 to 36. A raw score of 15 or higher on the Problem Scale is considered clinically significant child externalizing behavior.

Parenting Skills as measured by the Dyadic Parent-Child Interaction Coding System (DPICS-IV)

时间窗: Up to 26 weeks

The DPICS-IV is a behavioral observation tool used to code and assess caregiver behaviors and the quality of caregiver and child interactions. PCIT therapists code the three 5-minute DPICS-IV observations: (1) child-led play (CLP), (2) parent-led play (PLP), and (3) clean-up (CU). The number of positive parenting practices (e.g., labeled praises, reflections, and behavior descriptions) and negative parenting practices are tallied (e.g., questions, commands, and criticisms) are coded during CLP observations. During PLP and CU observations, caregiver verbalizations were coded to generate rates of: (1) caregiver effective commands, (2) caregiver correct follow-through on effective commands, and (3) child compliance to effective commands. The higher the score the higher the parenting behavior and child compliance.

Family conflict as measured by Bloom's Family Processes Scale

时间窗: Up to 26 weeks

The Bloom's Family Processes Scale assesses family conflict and cohesion using a 5-item conflict subscale (e.g. "we fight a lot in our family"). Caregivers rate their level of agreement on a five-point Likert scale (1=strongly agree to 5=strongly disagree). Total score ranges from 5-25 with the higher scores indicating greater conflict.

研究点 (4)

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