Randomized Controlled Trial of Comet Via the Internet or in Group Format.
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|ClinicalTrials.gov Identifier: NCT03465384|
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Oppositional Defiant Disorder Attention Deficit Hyperactivity Disorder||Behavioral: Comet||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are randomized to the standard intervention (Parent training in group format) or the experimental condition (Internet-based parent training).|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Independent clinicians will perform diagnostic assessments at pre and post measurements. The clinicians will be blind to the experimental condition the participants they assess.|
|Official Title:||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.|
|Actual Study Start Date :||March 19, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Active Comparator: Comet in group format
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.
The intervention is a behaviorally based and manualized parent training program.
Experimental: Internet-based Comet
The same content as the group format of Comet, but delivered mainly as online self-help.
The intervention is a behaviorally based and manualized parent training program.
- Eyberg Child Behavior Inventory (change in externalizing behaviors) [ Time Frame: 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.
- Strengths and Difficulties Questionnaire - subscale hyperactivity/inattention (change) [ Time Frame: 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).
- Mini International Neuropsychiatric Interview (change in diagnostic status) [ Time Frame: 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).
- Parenting Young Children (change in parenting strategies) [ Time Frame: Pre (0 month), Post (4 month) and Follow-up (12 month) ]A rating scale completed by parents measuring parenting behaviors and strategies. The parents both rate the frequency of different activities (range 21-105 - higher values represent better outcome) and indicate if they find the activity/strategy problematic (range 0-21 - higher values represent worse outcome).
- Adult-Child Relationship Scale (change in quality of relationship) [ Time Frame: Pre (0 month), Post (4 month) and Follow-up (12 month) ]A rating scale completed by parents measuring the level of warmth and conflict in the relationship between the parent and child. There is one subscale for each of these constructs which will be reported separately. Warmth in the relationship has a range of 5-25, where higher values represent warmer relationship. Conflict has a range of 4-28, where higher values represent more conflicts.
- Perceived Stress Scale (change in stress) [ Time Frame: Pre (0 month), Post (4 month) and Follow-up (12 month) ]A rating scale completed by parents measuring (own) perceived stress. The range of the scale is 0 to 40, with higher values representing more stress.
- Patient Health Questionnaire (change in depressive symptoms) [ Time Frame: Pre (0 month), Post (4 month) and Follow-up (12 month) ]A rating scale completed by parents measuring (own) depression. The range of the scale is 0 to 27, with higher values representing more depressive symptoms.
- Kiddy-KINDL Interview (change in quality of life) [ Time Frame: Pre (0 month) and Post (4 month) ]A structures interview that a clinician conducts with a child, measuring the experienced quality of life. The subscales pertaining relationship to parents (range 0-14, high values representing better relationship) and own wellbeing (range 0-12, higher values representing more wellbeing) will be used in the present study.
- Strengths and Difficulties Questionnaire - emotional/peer problems (change) [ Time Frame: 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 subscales related to child well-being (emotional problems and peer problems) will be used as a secondary outcome in this study. The range of both subscales are 0 to 10, where higher values represent more problems.
- Client Satisfaction Questionnaire [ Time Frame: Post (4 month) ]A rating scale completed by parents measuring the satisfaction with the offered intervention - range 8 to 32, where higher values represent higher satisfaction.
- Interview with clinicians about applicability of treatment [ Time Frame: Post (4 month) ]A structured interview will be conducted with a selection of the clinicians about their experience with the interventions in the study, in terms of satisfaction and applicability.
- Strengths and Difficulties Questionnaire - impact (change across intervention) [ Time Frame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11. ]The parents will each week throughout the intervention rate the present impact of their child's externalizing behaviors by completing the impact subscale of the Strengths and Difficulties Questionnaire (range 0-15, where higher values indicate more severe impact of the externalizing behaviors).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465384
|Contact: Martin Forster, PhDemail@example.com|
|Contact: Sigrid Salomonsson, PhDfirstname.lastname@example.org|
|Gustavsberg, Sweden, 13440|
|Contact: Johanna Engelbrektsson, M. Sc. +46722444709 email@example.com|
|Contact: Sigrid Salomonsson, PhD +4687186883 firstname.lastname@example.org|
|Handen, Sweden, 13646|
|Contact: Emma Wikell, M. Sc. +46707616227 email@example.com|
|Contact: Carolina Brantmo, M. Sc. +46705198474 firstname.lastname@example.org|
|Nacka, Sweden, 13230|
|Contact: Nina Micaux, M. Sc. +46704318179 email@example.com|
|Contact: Johnny Menoza, M. Sc. +46702838111 firstname.lastname@example.org|
|Stockholm, Sweden, 11359|
|Contact: Emma Supanich, M. Sc +46737173257 email@example.com|
|Contact: Åsa Palmqvist, M. Sc. +46734227579 firstname.lastname@example.org|
|Moment Psykologi||Not yet recruiting|
|Stockholm, Sweden, 11360|
|Contact: Sofie Bergling, M. Sc. +46722332103 email@example.com|
|Contact: Victor Bäckström, M. Sc. +46730488282 firstname.lastname@example.org|
|Stockholm, Sweden, 11763|
|Contact: Ylva Hanqvist, M. Sc. +46762347293 email@example.com|
|Contact: Martina Nilsson, M. Sc. +46736502629 firstname.lastname@example.org|
|Principal Investigator:||Martin Forster, PhD||Karolinska Institutet|