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临床试验/NCT06828302
NCT06828302已完成不适用

Internet-delivered Parent-Child Interaction for Parents of Children 2-7 Years With Disruptive Behaviors

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2025年3月10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
21
试验地点
1
主要终点
Eyberg Child Behavior Inventory

研究概览

简要总结

The goal of this feasibility study is to evaluate feasibility of Internet-delivered Parent-Child Interaction Therapy for parents of children 2-7 years with disruptive behaviors. The main questions it aims to answer are:

  1. Could a brief online version of PCIT (iPCIT) be feasible for reducing disruptive behaviors and internalizing problems in young children, and for improving the quality of parent-child interaction?
  2. How is iPCIT experienced by participating parents?

Participants will receive a 10-week online intervention of Parent-Child Interaction Therapy and answer questionnaires online weekly.

详细描述

Severe early behavioral problems increase the risk of impaired functioning in childhood and later life. Parent-Child Interaction Therapy (PCIT) is particularly effective for young children (age 2-7) with disruptive behaviors but is unimplemented in Sweden. Barriers to PCIT implementation include time constraints for parents and therapist challenges. An abbreviated internet-delivered version, iPCIT, may address these barriers. The objective of the study is to evaluate feasibility and acceptability of iPCIT.

Research questions

This study will use an uncontrolled pretest-posttest design, all participants will receive the intervention. The intervention consists of 10 weekly modules delivered over the Internet with guided support from an experienced CBT-trained psychologist and 5 biweekly videosessions where parents practice parental skills in a play situation with their child while receiving feedback and support from their therapist.

Assessments will be made pretreatment, weekly during treatment for the primary outcome and potential mediators, posttreatment, at the primary endpoint 2 months after treatment completion and at follow up 6 months after treatment completion. Twenty participants (parents of children aged 2-7 years) will be included. All outcome data will be collected digitally and include for feasibility: treatment credibility, working alliance, compliance with the treatment (number of modules completed), any adverse events, subjective overall relief and satisfaction with treatment. For potential efficacy, the clinical effect in the group will be analyzed on pre- to post-measurements, including weekly measurements and 2 months follow up after treatment termination (primary endpoint). The participants will be followed 6 months after treatment completion to analyze long term clinical effects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

Self-reported outcomes assessed online without any influence from study staff.

入排标准

年龄范围
2 Years 至 7 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children aged 2-7 years
  • •Disruptive behaviors as assessed with Eyberg Child Behavior Inventory (ECBI) ≥126 for boys and ≥121 for girls (which corresponds to the 90th percentile according to Swedish norms)
  • •Language ability equivalent to at least an average 2-year-old, defined as a vocabulary of ≥ 25 word and ability to understand simple instructions, assessed with a language screening form

排除标准

  • •Severe autism spectrum condition (autism level 2 or 3 or equivalent functioning)
  • •parents who are not proficient enough in the Swedish language to complete questionnaries and receive therapy without an interpreter
  • •Presence of severe parental psychiatric disorders such as psychosis or suicidal ideations
  • •Ongoing severe psychosocial distress such as custody dispute.

研究组 & 干预措施

iPCIT

Other

Online parent management training (PMT) to teach parental skills (10 weekly online modules) combined with videosession for coaching of parental skills (5 biweekly sessions)

干预措施: Internet-delivered Parent-Child Interaction Therapy (Behavioral)

结局指标

主要结局

Eyberg Child Behavior Inventory

时间窗: From pretreatment to 18 weeks

Caregiver report form measuring disruptive behaviors in children. 36 items with answers ranging from 1 (never) to 7 (always). Minimum value: 36. Maximum value: 252. A higher score means worse outcome.

次要结局

  • Brunnsviken Brief Quality of Life Scale(From pretreatment to 18 weeks)
  • Weekly assessment of Child Behavior Forms(From pretreatment to 18 weeks)
  • Child Behavior Checklist(From pretreatment to 10 weeks)
  • Dyadic Parent-Child Interaction Coding System(From pretreatment to 10 weeks)
  • Perceived Stress Scale(From pretreatment to 18 weeks)
  • Parental Stress Scale(From pretreatment to 18 weeks)
  • Difficulties in Emotion Regulation Scale(From pretreatment to 18 weeks)
  • Parenting Young Children Scale(From pretreatment to 18 weeks)

研究者

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

Marianne Bonnert

PhD, lic psych, principal investigator

Karolinska Institutet

研究点 (1)

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