- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03967509
Effectiveness of Behavioral Preschool Teacher Training for Externalizing (BPTT)
Effectiveness of the Cluster Randomized Comet-program Behavioral Preschool Teacher Training in Reducing Externalizing Behavior
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study:
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 to 22 waiting list control preschools, where preschool classes with the target child or children were program receivers. Informed preschools could apply for participation in the study, then, target children were screened for eligibility. 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).
Intervention:
The intervention was part of the Swedish evidence-based parent and teacher training programs (COmmunication METhod - Comet) for children and youths aged 3-12 and 12-18 years with moderate or elevated externalizing behavior, usually delivered in practitioner assisted group formats but previously evaluated as delivered via internet, single workshops followed by self-administered training, and universal prevention as well. Program implementations and evaluations are executed as collaboration projects between university researchers and the social services administration at place. Intervention content is influenced by operant conditioning, social learning theories, applied behavior analysis, and coercion theory. The focus is to establish a positive and effective interaction and communication style primarily through different reinforcement techniques (e.g., selective attention, more to positive behaviors and less to negative behaviors) and modeling. Parents or teachers meet in psychoeducational group sessions (often 9 to 11 sessions à 2.5 to 3 hours) led by one or two practitioner supervisors. They each follow a comprehensive manual and a highly structured curriculum. Training occurs at sessions (role-plays) and between sessions together with the children, followed-up with feedback in the next session.
Here an adapted version was tried in the preschool setting for the first time. The program corresponded in much to the parent training supplemented with techniques from the school teacher training and a group level administrated glove-puppet play technique to foster children's prosocial skills. (Results from the universal part of the program are not reported.) The nine sessions curriculum consisted of 2.5-hour biweekly meetings and two optional visits from supervisors with coaching on the spot. Practitioner supervisors (n = 27) were educated by a cognitive-behavior oriented psychologist during five days term one and two days term two.
Investigation issues:
The primary aim was to investigate behavioral outcome effects of the preschool teacher program. Would effects (Cohen's d) be in the medium-large range as found for Comet parent training (i.e., d = .50-.90) or in the small-medium range as often found for preventive developmental preschool programs (i.e., d = .20-.40)? With effects of about .40, a sample size restricted to 100 subjects, and an alpha at .05, power would be close to sufficient (i.e., .70). Of interest was to compare the effects of this program with effects found for other preschool program investigations of externalizing behavior problems.
Also investigated was eventual generalized effects to the children's homes. Of what magnitude would such effects be, if any, and would the parents' ratings validate the teachers' ratings, and thus, support the intervention? Such effects may have implications for future implementations, for example if the program is sufficiently efficient as a stand-alone intervention in reducing externalizing behavior problems or not sufficiently efficient. There was also a question of degree of informants agreement/discrepancy. Furthermore, would improved prosocial and regulatory skills function as a predictive and an intermediate mechanism for reduced problem behavior, and/or would there be room for other intervention features to contribute as well? In addition, as a trial in the real world, effects of implementation fidelity as well as social acceptability and relevance, such as proportions of children with reliable change, were investigated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Johanneshov
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Stockholm, Johanneshov, Sweden, 121 62
- Komet [Comet] Programs
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Elevated level of externalizing behavior
- Exceeding cutoff value 11 on the Strengths and Difficulties Questionnaire, total scale
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral teacher training
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.
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Other Names:
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No Intervention: Waiting list control group
Preschool teachers worked with children as usual.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sutter-Eyberg Student Behavior Inventory (SESBI)
Time Frame: Change measures: baseline (pre) and after 6 months (post).
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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.
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Change measures: baseline (pre) and after 6 months (post).
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Eyberg Child Behavior Inventory (ECBI)
Time Frame: Change measures: baseline (pre) and after 6 months (post).
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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.
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Change measures: baseline (pre) and after 6 months (post).
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Social Competence Scale (SCS)
Time Frame: Change measures: baseline (pre) and after 6 months (post).
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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.
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Change measures: baseline (pre) and after 6 months (post).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strengths and Difficulties Questionnaire (SDQ) Supplement - Impact and Burden
Time Frame: Change measures: baseline (pre) and after 6 months (post).
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A rating scale for teachers and parents asking about child difficulties with emotions, concentration, behavior, and getting on with other people on a 4-point scale from no difficulties to severe difficulties.
Consecutive items (three for teachers and five for parents) ask about child distress and social impairment in the domains of home life, friendships, classroom learning, and leisure activities.
Total range for teachers was 0-12 (first question included) and total range for parents was 0-15 (first question excluded).
Last, a burden item asks if the difficulties put a burden on the family or the preschool from not at all to much (range 0-3).
Impact and Burden are reported separately.
Higher values indicate more negative impact and burden because of behavior problems.
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Change measures: baseline (pre) and after 6 months (post).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Credibility/Expectancy Questionnaire
Time Frame: At baseline (pre).
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Teachers and supervisors rated how much they believed in the method and their expectations of improvement in terms of five items covering reasonableness, degree of belief in magnitude of impact on externalizing and other behavior problems, willingness to recommend, and expectation of improvement of the preschool situation on a 10-point scale from not at all to much.
Total mean score could vary between 1 and 10, where higher score means higher credibility/expectancy beliefs.
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At baseline (pre).
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Program fidelity, teacher
Time Frame: Reported per 9 biweekly sessions after intervention at 5 months.
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Teachers reported on program fidelity per session: attendance and number of program components/techniques accomplished.
Session attendance was reported as the ratio of attending teachers to participating teachers for each session.
Accomplishment and techniques used were categorized as educational themes (0-1, max = 36), role-plays (0-2: none, observing other roleplay, own role-play, max = 22), homework assignments (0-1 or 2, max = 33), and feedback on training between sessions (0-2: none, some, detailed, max = 16).
Teacher fidelity measures were reported as means per program component and percentage of accomplishment.
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Reported per 9 biweekly sessions after intervention at 5 months.
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Program fidelity and teacher reliability check, supervisor
Time Frame: After intervention at 5 months.
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Supervisors reported on four fidelity themes: 1. Self-report on manual content completed.
2. Three ratings of teacher accomplishment: 2. session attendance, 3. role-plays, and 4. homework assignments completed on a 5-point scale from not at all to fully.
Supervisor fidelity measure was reported as total mean and percentage of accomplishment.
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After intervention at 5 months.
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Consumer satisfaction, teacher
Time Frame: After intervention at 5 months.
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Preschool teachers rated perceived 1. effectiveness, 2. comprehension of the methods, and 3. support of their professional role on a 4-point scale from not at all (1), little (2), pretty much (3), to very (4).
Reported as percentage of teachers per category.
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After intervention at 5 months.
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Consumer satisfaction, supervisor
Time Frame: After intervention at 5 months.
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Supervisors reported on support and time for their work from their employer on a 4-point categorical scale from neither support or time (1), time, but lack of support (2), support, but lack of time (3) to both support and time (4) reported in percentages per category.
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After intervention at 5 months.
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Motivation
Time Frame: After intervention at 5 months.
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Motivation to participate in the program was rated by teachers and supervisors on 4 scale steps from not at all to very motivated and reported in percentages.
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After intervention at 5 months.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Åsa K Kling, PhD student, Uppsala University
- Study Chair: Mats Fredrikson, Professor, Uppsala University
Publications and helpful links
General Publications
- Eyberg, S., Pincus, D. Eyberg Child behavior Inventory (ECBI) and Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R). Professional manual. Odessa, Florida: PAR, 1999.
- Conduct Problems Prevention Research Group. Social Competence Scale (Parent), 1995. Retrieved from the Fast Track Project: http://www.fasttrackproject.org
- 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
- 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.
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSA: DNR 3.2-0665/2009
- 00-86/2009-36 (Other Identifier: National Board of Health and Welfare)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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