跳至主要内容
临床试验/NCT03465384
NCT03465384已完成不适用

Parent Training Targeting Externalizing Behaviors in Children in Primary Care: A Randomized Non-inferiority Study of the Comet-program Delivered Via the Internet or in Group Format.

Karolinska Institutet7 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2018年3月19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
161
试验地点
7
主要终点
Eyberg Child Behavior Inventory (change in externalizing behaviors)

研究概览

简要总结

The Comet-program is a Swedish parent training program developed to target externalizing behaviors in children between 3-11 years. The program is normally delivered in group format in primary and specialized care and has already been evaluated in several studies. The internet-based version of the program has also been evaluated separately, but in this study the two formats will be directly compared in a randomized non-inferiority study. Parent ratings, child ratings as well as blinded clinical assessments will be conducted before the interventions, after the interventions (2-3 month after start of intervention), and at follow-up (12 mont after first assessment). The primary research question is: Will the internet-based format of Comet be at least as effective as the group format in reducing externalizing behaviors? Secondary research questions concern possible differential effects of the two formats on cost-effectiveness, parenting behaviors, parent mental health, applicability and consumer satisfaction, and the children's quality of life.

详细描述

Background:

The Comet-program is a Swedish parent training program developed to target externalizing behaviors in children between 3-11 years. The program content is behaviorally oriented and the emphasis lies on increasing parenting behaviors that reinforces pro-social behaviors in children, as well as limiting the reinforcement of anti-social behaviors. The program is manualized and normally delivered in group format with parents to 6-8 children in each group. The group sessions (11 sessions á 2.5 hours) are led by two practitioners and include information, role-playing, and home-work exercises. The group format has been evaluated in two large randomized controlled studies. The effect sizes on child externalizing behaviors have been medium to large (Cohen´s d). Because of the evidence supporting Comet and other research supporting the effectiveness of similar behavioral parenting programs, Comet has been implemented in primary and specialized care in Sweden. A challenge in primary care is however the implementation costs related to the program (e.g., training of group leaders and the time each group leader need to invest in each patient). Therefore, Comet (or similar programs) are in practice used to a small extent in primary care, despite clear recommendations to offer such treatments for externalizing behaviors. A possible solution would be to offer an internet-based version of the program, which in two large randomized controlled trials have shown medium effect sizes on externalizing behaviors in children. In the internet-based version, the patients (parents) work online with seven modules over a period of nine weeks. Every module contains information, video-clips, quizzes and homework exercises. Every week the patient communicates with a therapist, that gives brief guidance and feedback online.

The internet-based format of the program has however been implemented at a very small scale in regular care. One reason is probably reluctance on part of practitioners as well as patients in replacing face-to-face contact with online-contact. The management system used in health-care in Sweden is another obstacle, since only face-to-face contacts are included. Hence, the clinics are not financially compensated for any patient contacts online. To overcome these obstacles, the present study will compare the regular Comet program in group format to a modified version of the internet-based version. In the modified version, the online contact between the patient and the therapist will be replaced with three individual face-to-face sessions (45 min each). This will reduce the total amount of time invested per patient to 135 mins, compared to 410-550 mins per patient in the group format.

Research questions:

The primary research question in the study is: (1) Will the internet-based version of Comet be at least as effective as the group format in reducing externalizing behaviors in children?

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)

盲法说明

Independent clinicians will perform diagnostic assessments at pre and post measurements. The clinicians will be blind to the experimental condition the participants they assess.

入排标准

年龄范围
3 Years 至 11 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Primary reason for contact with health care is child externalizing behaviors.

排除标准

  • •Not sufficiently fluent in written Swedish to be able to take part in an internet-based (text-based) intervention.
  • •No access to computer/ipad/phone
  • •Social problems that makes investigation or intervention from the social services necessary.

研究组 & 干预措施

Comet in group format

Active Comparator

The standard format of the intervention that is well established in primary and specialized care in Sweden. Parents receive the education/training in small groups led by two group leaders.

干预措施: Comet (Behavioral)

Internet-based Comet

Experimental

The same content as the group format of Comet, but delivered mainly as online self-help.

干预措施: Comet (Behavioral)

结局指标

主要结局

Eyberg Child Behavior Inventory (change in externalizing behaviors)

时间窗: Pre (0 month), Post (4 month) and Follow-up (12 month)

A rating scale completed by parents measuring externalizing behaviors in children. The scale contains two subscales which both will be reported independently as outcomes in this study: The intensity scale (range 36-252) and the problem scale (range 0-36). In both cases higher values indicate more externalizing behaviors.

Mini International Neuropsychiatric Interview (change in diagnostic status)

时间窗: Pre (0 month) and Post (4 month)

A structured diagnostic interview conducted by clinicians with parents and (if possible) the child. Only the sections for ADHD and ODD will be used in the present study. Outcomes that will be reported are diagnostic status of both ADHD and ODD (yes/no), the number of symptoms (range 0-20 for ADHD and 0-9 for ODD), and the clinician rated severity (range 0-8 for each diagnosis, where higher value represents more severe problems).

Strengths and Difficulties Questionnaire - subscale hyperactivity/inattention (change)

时间窗: Pre (0 month), Post (4 month) and Follow-up (12 month)

A rating scale completed by parents measuring both externalizing and internalizing behaviors in children, as well as the impact of such behaviors. The subscale of hyperactivity/attention problems will be used as a primary outcome in this study (range 0-10, where higher values represent more hyperactivity/inattention).

次要结局

  • Parenting Young Children (change in parenting strategies)(Pre (0 month), Post (4 month) and Follow-up (12 month))
  • Kiddy-KINDL Interview (change in quality of life)(Pre (0 month) and Post (4 month))
  • Client Satisfaction Questionnaire(Post (4 month))
  • Adult-Child Relationship Scale (change in quality of relationship)(Pre (0 month), Post (4 month) and Follow-up (12 month))
  • Interview with clinicians about applicability of treatment(Post (4 month))
  • Perceived Stress Scale (change in stress)(Pre (0 month), Post (4 month) and Follow-up (12 month))
  • Patient Health Questionnaire (change in depressive symptoms)(Pre (0 month), Post (4 month) and Follow-up (12 month))
  • Strengths and Difficulties Questionnaire - emotional/peer problems (change)(Pre (0 month), Post (4 month) and Follow-up (12 month))

研究者

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

Martin Forster

PhD

Karolinska Institutet

研究点 (7)

Loading locations...

相似试验