NCT03967509

Brief Summary

A cluster randomized controlled pre-post effectiveness trial of behavioral preschool teacher training (BPTT) delivered in a practitioner assisted group format for children with externalizing behavior problems. Preschools were randomized to either intervention in 25 preschools or as 22 waiting list control preschools, where teachers in preschool classes with the target child or children were program receivers. Participants were 100 target children 3-5 years old together with 72 enrolled preschool teachers and 83 parents as informants of behavioral outcomes after a five months period of implementation (at six months). The intervention was part of the Swedish evidence-based parent and teacher training programs (Comet) for children and youth with elevated externalizing behavior, and here an adapted version was tried in preschool for the first time. Also investigated was eventual generalized effects to the children's homes and improved social competence as an intermediate mechanism for reduced problem behavior. Effects of implementation fidelity in addition to social acceptability and relevance, such as reliable change, was investigated as well.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2011

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

2.5 years

First QC Date

May 24, 2019

Last Update Submit

June 18, 2019

Conditions

Keywords

Externalizing behavior problemsSocial competenceSchool readinessTeacher management trainingCluster randomized effectiveness trial

Outcome Measures

Primary Outcomes (3)

  • Sutter-Eyberg Student Behavior Inventory (SESBI)

    A rating scale for teachers measuring child externalizing behaviors. The two subscales Intensity (range 38-266) representing frequency, severity, or level of problem behaviors occurring from never (1) to always (7) and Problem (range 0-38) reflecting behaviors that are perceived as problems or not are reported independently. Higher values indicate more externalizing behaviors or more problems.

    Change measures: baseline (pre) and after 6 months (post).

  • Eyberg Child Behavior Inventory (ECBI)

    A rating scale for parents measuring child externalizing behaviors. The two subscales Intensity (range 36-252) representing frequency, severity, or level of problem behaviors occurring from never (1) to always (7) and Problem (range 0-36) reflecting behaviors that are perceived as problems or not are reported independently. Higher values indicate more externalizing behaviors or more problems.

    Change measures: baseline (pre) and after 6 months (post).

  • Social Competence Scale (SCS)

    A rating scale for teachers and parents estimating child prosocial behavior, communicative skills, and self-control containing two 5-point subscales with six items each; Prosocial (e.g., solve conflicts, share, helpful, listen, not bossy) and Emotional regulation (e.g., can accept a failure, calm down, think before acting, control temper). The total score may vary between 12 and 60. Higher values indicate better social competence.

    Change measures: baseline (pre) and after 6 months (post).

Secondary Outcomes (1)

  • Strengths and Difficulties Questionnaire (SDQ) Supplement - Impact and Burden

    Change measures: baseline (pre) and after 6 months (post).

Other Outcomes (6)

  • Credibility/Expectancy Questionnaire

    At baseline (pre).

  • Program fidelity, teacher

    Reported per 9 biweekly sessions after intervention at 5 months.

  • Program fidelity and teacher reliability check, supervisor

    After intervention at 5 months.

  • +3 more other outcomes

Study Arms (2)

Behavioral teacher training

EXPERIMENTAL

Behavioral preschool teacher training (BPTT) delivered in an educational group format during nine 2,5-hour biweekly sessions with training at sessions and in between followed by supervisor's feedback on the practice and two optional coaching occasions on the spot.

Behavioral: Comet

Waiting list control group

NO INTERVENTION

Preschool teachers worked with children as usual.

Interventions

CometBEHAVIORAL
Also known as: Comet in group format
Behavioral teacher training

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Elevated level of externalizing behavior
  • Exceeding cutoff value 11 on the Strengths and Difficulties Questionnaire, total scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Komet [Comet] Programs

Stockholm, Johanneshov, 121 62, Sweden

Location

Related Publications (15)

  • Eyberg, S., Pincus, D. Eyberg Child behavior Inventory (ECBI) and Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R). Professional manual. Odessa, Florida: PAR, 1999.

    BACKGROUND
  • Conduct Problems Prevention Research Group. Social Competence Scale (Parent), 1995. Retrieved from the Fast Track Project: http://www.fasttrackproject.org

    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.

  • 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.

  • Forster, M., Sundell, K., Morris, R, Karlberg, M., Melin, L. A randomized controlled trial of a standardized behavior management intervention for students with externalizing behavior. Journal of Emotional and Behavioral Disorders, 20(3): 169-183, 2012

    RESULT
  • Forster, M., Kling, Å., Sundell, K. Clinical significance of parent training for children with conduct problems. International Journal of Conflict and Violence, 6(2): 187-200, 2012.

    RESULT
  • 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.

  • 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.

  • 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.

  • Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.

  • Goodman R. The extended version of the Strengths and Difficulties Questionnaire as a guide to child psychiatric caseness and consequent burden. J Child Psychol Psychiatry. 1999 Jul;40(5):791-9.

  • 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.

  • Malmberg M, Rydell AM, Smedje H. Validity of the Swedish version of the Strengths and Difficulties Questionnaire (SDQ-Swe). Nord J Psychiatry. 2003;57(5):357-63. doi: 10.1080/08039480310002697.

  • Axberg U, Johansson Hanse J, Broberg AG. Parents' description of conduct problems in their children - a test of the Eyberg Child Behavior Inventory (ECBI) in a Swedish sample aged 3-10. Scand J Psychol. 2008 Dec;49(6):497-505. doi: 10.1111/j.1467-9450.2008.00670.x. Epub 2008 Aug 12.

  • Conduct Problems Prevention Research Group. Social Competence Scale (Parent) - Technical reports, 1995-2002. Retrieved from: http://www.fasttrackproject.org

    RESULT

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior DisordersProblem BehaviorAttention Deficit Disorder with HyperactivitySocial Skills

Interventions

Comet Assay

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersBehavioral SymptomsBehaviorChild BehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Electrophoresis, Agar GelElectrophoresisChemistry Techniques, AnalyticalInvestigative TechniquesElectrochemical TechniquesMutagenicity TestsGenetic TechniquesToxicity Tests

Study Officials

  • Åsa K Kling, PhD student

    Uppsala University

    PRINCIPAL INVESTIGATOR
  • Mats Fredrikson, Professor

    Uppsala University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Preschools randomized to either behavioral teacher training or as waiting list control preschools.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 30, 2019

Study Start

August 18, 2008

Primary Completion

February 3, 2011

Study Completion

February 3, 2011

Last Updated

June 20, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

There is a plan to make IPD and related data dictionaries available.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Three months after publication and five years hereafter.
Access Criteria
If similar type of data including measures (all IPD) are available elsewhere, and it is possible to aggregate data, then a data collaboration project might be a possibility.

Locations