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临床试验/NCT03260725
NCT03260725已完成不适用

Evaluating the Feasibility of Internet-delivered Parent-Child Interaction Therapy

Florida International University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Clinical Global Impressions (CGI) Improvement Scale

研究概览

简要总结

The present study is leveraging a randomized-controlled design to evaluate an Internet-based format for the delivery of Parent-Child Interaction Therapy (I-PCIT). Drawing on videoteleconferencing technology, this format affords real-time interactions for the provision of care traditionally delivered in person, regardless of a family's geographic proximity to a mental health facility. Moreover, drawing on technological innovation to deliver interventions directly to families in their natural settings may extend the ecological validity of PCIT, as treatment is delivered in the very context in which child problems occur. Families seeking treatment for early child disruptive behavior problems (N=40) are being randomly assigned to either receive Internet-delivered PCIT or clinic-based PCIT. Outcomes and feasibility/acceptability will be assessed across the treatment phase as well as at post-treatment and 6-month follow-up.

详细描述

Establishing the feasibility of an Internet-based format for the delivery of evidence-based parent management is a critical step in the evaluation of technological innovations and their potential for advancing children's mental health care. Drawing on teleconferencing technology, such a format affords real-time interactions for the provision of care traditionally delivered in person, regardless of a family's geographic proximity to a mental health facility. Moreover, drawing on technological innovation to deliver interventions directly to families in their natural settings may extend the ecological validity of treatments, as treatments are delivered in the very contexts in which child problems occur.

The objective of the present study is to develop an Internet-delivered Parent-Child Interaction Therapy (PCIT) protocol for preschoolers with Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD) and to evaluate via randomized controlled trial (RCT) the feasibility and acceptability of enrolling, retaining, and treating children with I-PCIT relative to traditional PCIT. Phase I will involve development of an Internet-delivered PCIT (I-PCIT) protocol and treatment materials, including therapist treatment manual and online session handouts. Phase II will entail a case series: the PI will treat 5 consecutive preschool ODD/CD cases with I-PCIT, affording opportunity to further work out any difficulties with protocol or equipment. Phase III will entail testing the feasibility and acceptability of I-PCIT in a pilot RCT conducted with 40 children (ages 3-5) meeting for a Diagnostic and Statistical Manual (DSM-IV) principal diagnosis of ODD or CD and their parent(s) randomly assigned to I-PCIT or traditional PCIT. Parents will provide informed consent. All eligible families will receive evidence based treatment. Treatment will either be either in-clinic Parent-Child Interaction Therapy (PCIT) or Internet-delivered PCIT (I-PCIT). Formal evaluations will be conducted at baseline, post-treatment, and 6-month follow-up. Families can opt to participate in two optional psychophysiological components of the study (one involving behavioral tasks while parents are monitored via physiological equipment, and one involving play tasks while children are monitored via physiological equipment). All assessments will be conducted in the Department of Psychology at Florida International University (FIU), in the Center for Children and Families.

研究设计

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

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children (ages 3-5) meeting for DSM-IV principal Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD), and at least 1 primary caretaker.
  • Eyberg Child Behavior Inventory-Intensity Score in clinical range (i.e., >132).
  • English-speaking (child & caretakers).
  • Family home equipped w/ broadband connection and computer equipped with Pentium (or compatible) processor, 128 MB random-access memory (RAM), 200 Megabytes available of hard disk space, 16-bit color display adapter, universal series bus (USB) port.

排除标准

  • Behavior problems due to organic pathology or trauma,
  • Child receiving medication to manage behavior difficulties,
  • Presence of child emotional/behavior problem more impairing than ODD or CD,
  • Parent or child score <75 standard score on intelligence quotient (IQ) screening,
  • History of severe physical or mental impairments (e.g., mental retardation, deafness, blindness, pervasive developmental disorder) in child or participating caretaker(s).
  • Child is a ward of the state

结局指标

主要结局

Clinical Global Impressions (CGI) Improvement Scale

时间窗: Post-treatment (average = 35.2 weeks)

Most widely used clinician-rated measure of treatment-related changes in functioning. The CGI-Improvement rates improvement on a 7-point scale, ranging from 1 ("very much improved") to 7 ("very much worse"). CGI-Improvement scores of 1 ("very much improved") or 2 ("much improved") reflect "treatment response." CGI-Improvement scores of 1 ("very much improved") reflect "excellent response." Completed by Independent Evaluator (IE) in present study.

次要结局

  • Kiddie Disruptive Behavior Disorders Schedule (K-DBDS)(Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up)
  • Children's Global Assessment Scale (CGAS)(Baseline, post-treatment (average = 35.2 weeks), and 6 month follow-up)
  • Child Behavior Checklist for ages 1.5 to 5 (CBCL 1.5-5)(Baseline, mid-treatment (average = 17.2 weeks), post treatment (average = 35.2 weeks), and 6 month follow-up)
  • Barriers to Treatment Participation Scale (BTPS)(Mid-treatment (average = 17.2 weeks) and post treatment (average = 35.2 weeks))
  • Therapy Attitude Inventory (TAI)(Posttreatment (average = 35.2 weeks))
  • Eyberg Child Behavior Inventory (ECBI)(Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up)
  • Client Satisfaction Questionnaire (CSQ-8)(Post-treatment (average = 35.2 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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