CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 161 enrolled
Drug / intervention
Cometbehavioral
Likely dose
Not stated in record
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Search/NCT03465384
NCT03465384N/ACompleted

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 Institutet·interventional·Posted Mar 14, 2018·Updated Mar 10, 2022

In Brief

A clinical study evaluating Comet for Oppositional Defiant Disorder and Attention Deficit Hyperactivity Disorder. Completed, enrolled 161 participants across 7 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
CollaboratorsRegion Stockholm

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 14, 2018
Enrollment StartMar 19, 2018
Primary CompletionNov 20, 2020
Study CompletionDec 20, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.3 years ago

Interventions

Cometbehavioral

The intervention is a behaviorally based and manualized parent training program.