Clinical trial NCT03967509: Effectiveness of Behavioral Preschool Teacher Training for Externalizing
Official title: Effectiveness of the Cluster Randomized Comet-program Behavioral Preschool Teacher Training in Reducing Externalizing Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit and Disruptive Behavior Disorders
Problem Behavior
Attention Deficit Disorder With Hyperactivity
Keywords: Externalizing behavior problems
Social competence
School readiness
Teacher management training
Cluster randomized effectiveness trial
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: The Social Services Administration
name: Ministry of Health and Social Affairs, Sweden
First posted: 2019-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Preschools randomized to either behavioral teacher training or as waiting list control preschools.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Sutter-Eyberg Student Behavior Inventory (SESBI)
timeFrame: Change measures: baseline (pre) and after 6 months (post).
measure: Eyberg Child Behavior Inventory (ECBI)
timeFrame: Change measures: baseline (pre) and after 6 months (post).
measure: Social Competence Scale (SCS)
timeFrame: Change measures: baseline (pre) and after 6 months (post).
Secondary outcomes:
measure: Strengths and Difficulties Questionnaire (SDQ) Supplement - Impact and Burden
timeFrame: Change measures: baseline (pre) and after 6 months (post).
Other outcomes:
measure: Credibility/Expectancy Questionnaire
timeFrame: At baseline (pre).
measure: Program fidelity, teacher
timeFrame: Reported per 9 biweekly sessions after intervention at 5 months.
measure: Program fidelity and teacher reliability check, supervisor
timeFrame: After intervention at 5 months.
measure: Consumer satisfaction, teacher
timeFrame: After intervention at 5 months.
measure: Consumer satisfaction, supervisor
timeFrame: After intervention at 5 months.
measure: Motivation
timeFrame: After intervention at 5 months.
Locations:
city: Stockholm
country: Sweden
facility: Komet [Comet] Programs
state: Johanneshov
Study officials:
affiliation: Uppsala University
name: Åsa K Kling, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Mats Fredrikson, Professor
role: STUDY_CHAIR
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