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

NCT03465384 | Completed

• 1 other identifier: ikometvskomet
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Parent-Child relations; Parenting; Non-inferiority trial; Externalizing behaviors; Randomized controlled trial; Cost-effectiveness

Outcome Measures

Primary Outcomes (3)

• Eyberg Child Behavior Inventory (change in externalizing behaviors)

  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.

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

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

  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).

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

• Mini International Neuropsychiatric Interview (change in diagnostic status)

  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).

  Pre (0 month) and Post (4 month)

Secondary Outcomes (8)

• Parenting Young Children (change in parenting strategies)

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

• Adult-Child Relationship Scale (change in quality of relationship)

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

• Kiddy-KINDL Interview (change in quality of life)

  Pre (0 month) and Post (4 month)

Other Outcomes (1)

• Strengths and Difficulties Questionnaire - impact (change across intervention)

  Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11.

Study Arms (2)

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.

Behavioral: Comet

Internet-based Comet

EXPERIMENTAL

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

Behavioral: Comet

Interventions

Comet BEHAVIORAL

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

Comet in group format; Internet-based Comet

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (7)

Gustavsbergs VC

Gustavsberg, 13440, Sweden

Location

Rudans VC

Handen, 13646, Sweden

Location

Boo VC

Nacka, 13230, Sweden

Location

Inside Team

Stockholm, 11359, Sweden

Location

Moment Psykologi

Stockholm, 11360, Sweden

Location

Liljeholmens BUMM

Stockholm, 11763, Sweden

Location

Alva Barnklinik

Stockholm, 118 72, Sweden

Location

Related Publications (23)

• Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.

  PMID: 10259963 BACKGROUND

• Bullinger M, Brutt AL, Erhart M, Ravens-Sieberer U; BELLA Study Group. Psychometric properties of the KINDL-R questionnaire: results of the BELLA study. Eur Child Adolesc Psychiatry. 2008 Dec;17 Suppl 1:125-32. doi: 10.1007/s00787-008-1014-z.

  PMID: 19132312 BACKGROUND

• Enebrink P, Hogstrom J, Forster M, Ghaderi A. Internet-based parent management training: a randomized controlled study. Behav Res Ther. 2012 Apr;50(4):240-9. doi: 10.1016/j.brat.2012.01.006. Epub 2012 Jan 30.

  PMID: 22398153 BACKGROUND

• Essau, C. A., Sasagawa, S., & Frick, P. J. (2006). Psychometric Properties of the Alabama Parenting Questionnaire. Journal of Child and Family Studies, 15(5), 595-614.

  BACKGROUND

• Eyberg, S. M., & Pincus, D. (1999). Eyberg Child Behavior Inventory (ECBI) and Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R). Professional manual. Odessa, FL: Psychological Assessment Resources.

  BACKGROUND

• Flight L, Julious SA. Practical guide to sample size calculations: non-inferiority and equivalence trials. Pharm Stat. 2016 Jan-Feb;15(1):80-9. doi: 10.1002/pst.1716. Epub 2015 Nov 25.

  PMID: 26604186 BACKGROUND

• Folkhälsomyndigheten. (2013). Så arbetar kommuner, landsting, kommun- och regionförbund och ideella organisationer med föräldrastöd. Östersund & Stockholm.

  BACKGROUND

• Ghaderi A, Kadesjo C, Bjornsdotter A, Enebrink P. Randomized effectiveness Trial of the Family Check-Up versus Internet-delivered Parent Training (iComet) for Families of Children with Conduct Problems. Sci Rep. 2018 Jul 31;8(1):11486. doi: 10.1038/s41598-018-29550-z.

  PMID: 30065246 BACKGROUND

• Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.

  PMID: 11699809 BACKGROUND

• Hogstrom J, Olofsson V, Ozdemir M, Enebrink P, Stattin H. Two-Year Findings from a National Effectiveness Trial: Effectiveness of Behavioral and Non-Behavioral Parenting Programs. J Abnorm Child Psychol. 2017 Apr;45(3):527-542. doi: 10.1007/s10802-016-0178-0.

  PMID: 27334706 BACKGROUND

• Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.

  PMID: 15195324 BACKGROUND

• Kling A, Forster M, Sundell K, Melin L. A randomized controlled effectiveness trial of parent management training with varying degrees of therapist support. Behav Ther. 2010 Dec;41(4):530-42. doi: 10.1016/j.beth.2010.02.004. Epub 2010 Oct 1.

  PMID: 21035616 BACKGROUND

• McEachern AD, Dishion TJ, Weaver CM, Shaw DS, Wilson MN, Gardner F. Parenting Young Children (PARYC): Validation of a Self-Report Parenting Measure. J Child Fam Stud. 2012 Jun;21(3):498-511. doi: 10.1007/s10826-011-9503-y.

  PMID: 22876108 BACKGROUND

• Nordin M, Nordin S. Psychometric evaluation and normative data of the Swedish version of the 10-item perceived stress scale. Scand J Psychol. 2013 Dec;54(6):502-7. doi: 10.1111/sjop.12071. Epub 2013 Oct 5.

  PMID: 24118069 BACKGROUND

• Sampaio F, Enebrink P, Mihalopoulos C, Feldman I. Cost-Effectiveness of Four Parenting Programs and Bibliotherapy for Parents of Children with Conduct Problems. J Ment Health Policy Econ. 2016 Dec 1;19(4):201-212.

  PMID: 27991419 BACKGROUND

• Schumi J, Wittes JT. Through the looking glass: understanding non-inferiority. Trials. 2011 May 3;12:106. doi: 10.1186/1745-6215-12-106.

  PMID: 21539749 BACKGROUND

• Sheehan DV, Sheehan KH, Shytle RD, Janavs J, Bannon Y, Rogers JE, Milo KM, Stock SL, Wilkinson B. Reliability and validity of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). J Clin Psychiatry. 2010 Mar;71(3):313-26. doi: 10.4088/JCP.09m05305whi.

  PMID: 20331933 BACKGROUND

• Socialstyrelsen. (2009). Socialtjänstens öppna verksamheter för barn och unga - en nationell inventering av metoder. Stockholm.

  BACKGROUND

• Stattin H, Enebrink P, Ozdemir M, Giannotta F. A national evaluation of parenting programs in Sweden: The short-term effects using an RCT effectiveness design. J Consult Clin Psychol. 2015 Dec;83(6):1069-1084. doi: 10.1037/a0039328. Epub 2015 May 25.

  PMID: 26009784 BACKGROUND

• Titov N, Dear BF, McMillan D, Anderson T, Zou J, Sunderland M. Psychometric comparison of the PHQ-9 and BDI-II for measuring response during treatment of depression. Cogn Behav Ther. 2011;40(2):126-36. doi: 10.1080/16506073.2010.550059.

  PMID: 25155813 BACKGROUND

• Trentacosta CJ, Criss MM, Shaw DS, Lacourse E, Hyde LW, Dishion TJ. Antecedents and outcomes of joint trajectories of mother-son conflict and warmth during middle childhood and adolescence. Child Dev. 2011 Sep-Oct;82(5):1676-90. doi: 10.1111/j.1467-8624.2011.01626.x. Epub 2011 Aug 29.

  PMID: 21883153 BACKGROUND

• Vårdgivarguiden. (2017). Vägledningsdokument: Utagerande beteende hos barn och unga med psykisk ohälsa.

  BACKGROUND

• Engelbrektsson J, Salomonsson S, Hogstrom J, Sorjonen K, Sundell K, Forster M. Parent Training via Internet or in Group for Disruptive Behaviors: A Randomized Clinical Noninferiority Trial. J Am Acad Child Adolesc Psychiatry. 2023 Sep;62(9):987-997. doi: 10.1016/j.jaac.2023.01.019. Epub 2023 Feb 28.

  PMID: 36863414 DERIVED

MeSH Terms

Conditions

Oppositional Defiant Disorder; Attention Deficit Disorder with Hyperactivity

Interventions

Comet Assay

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electrophoresis, Agar Gel; Electrophoresis; Chemistry Techniques, Analytical; Investigative Techniques; Electrochemical Techniques; Mutagenicity Tests; Genetic Techniques; Toxicity Tests

Study Officials

• Martin Forster, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent clinicians will perform diagnostic assessments at pre and post measurements. The clinicians will be blind to the experimental condition the participants they assess.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Participants are randomized to the standard intervention (Parent training in group format) or the experimental condition (Internet-based parent training).

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 14, 2018
• Study Start: March 19, 2018
• Primary Completion: November 20, 2020
• Study Completion: December 20, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-03

Locations

SE (7)