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Randomized Controlled Trial of Comet Via the Internet or in Group Format.

NCT03465384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2022-03-10

No results posted yet for this study

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.

Conditions

  • Oppositional Defiant Disorder
  • Attention Deficit Hyperactivity Disorder

Interventions

BEHAVIORAL

Comet

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

Sponsors & Collaborators

Principal Investigators

  • Martin Forster, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2020-11-20
Completion
2021-12-20

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03465384 on ClinicalTrials.gov