Clinical trial NCT06127030: Brief Behavioral Teacher Training for Behavioral Difficulties
Official title: The Effectiveness of a Brief Behavioral Training for Teachers of Children With Behavioral Difficulties at School: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavioral Difficulties
Behavioral Problem of Child
Keywords: Behavioral teacher training
Brief teacher training
Individually-tailored
School-based support
Lead sponsor: Accare
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To examine the research objectives, a randomized controlled trial with two arms will be used. Teachers will be randomly assigned (equal randomization) to (a) brief teacher training with practice as usual (PAU) or (b) PAU only
Primary purpose: TREATMENT

Brief summary: The goal of this two-armed randomized controlled trial is to investigate the effectiveness of a new, individually tailored, brief behavioral training for teachers of children with behavioral difficulties at school.

The main questions the study aims to answer are:

* Does the brief teacher training reduce the severity of four daily rated target behaviors in specific classroom situations compared to practice as usual (PAU) on the short term?
* Does the brief teacher training program reduce the severity of the same four daily rated target behaviors in other classroom situations, behavioral difficulties of the child at school and at home, and the impairment of the child in the school situation and reduce the number of behavioral difficulties of the child at school judged as troublesome by the teacher, and improve the teacher-student relationship quality, teachers' sense of efficacy, and teachers' behavior management strategies compared to practice as usual (PAU) on the short term?
* Are short-term improvements maintained at 3 months follow-up?

Teachers will be randomly assigned (simple randomization) to (a) three sessions of brief teacher training with PAU, or (b) PAU only. The brief teacher training provides teachers with individually tailored stimulus control and contingency management techniques to treat children's behavioral difficulties in two (bi)weekly training sessions of two hours and a third session of one hour in which the training will be evaluated and maintenance training will be provided. PAU may include any support or treatment as regularly provided by mental health care centers, schools, school collaborations and/or other organizations, except from pharmacological treatment for children's behavioral difficulties and/or behavioral teacher training/support. PAU can also imply that there is no support or treatment.

Detailed description: INTRODUCTION AND RATIONALE

Behavioral difficulties, such as inattentive, impulsive, hyperactive, oppositional and/or aggressive behaviors, are highly prevalent in children and adolescents and one of the most common reasons for referral to mental health care. When left untreated, problems may exacerbate, grow into disorders and put children at risk of subsequent adverse outcomes, such as school dropout, delinquency, substance use, and/or depression. Ideally, treatment should prevent the escalation of problems, reduce the need for long and intensive treatments (including antipsychotics or other medication), and lower societal costs.

Behavioral teacher training is a promising intervention to treat children's behavioral difficulties at school. In the Netherlands, there are currently no brief and individual teacher training interventions available for this group of children. Existing programs are either self-help interventions, long programs that are not tailored to the individual teacher's and child's needs, or programs that focus on peer-support. There is thus an urgent need for a brief, accessible, and individually tailored teacher training programs.

To address this need, the Investigators will evaluate a brief, individually-tailored behavioral teacher training program based on effective training elements identified in our earlier work. Our previous project showed that effects of a brief teacher training on behavioral difficulties were promising, while the dropout rates of teachers were low. Teachers were particularly positive about the short time span of the training and the program's focus on tailoring program content to the individual problems that teachers and/or the child experience.

OBJECTIVES

Primary objective:

• To examine the short term effectiveness of a brief, individually-tailored, behavioral teacher training program on the severity of four daily rated target behaviors in specific classroom situations.

Secondary objectives:

* To examine the short term effectiveness of the teacher training on secondary outcome measures: the severity of the same four daily rated target behaviors in other classroom situations, behavioral difficulties of the child at school and at home, the number of behavioral difficulties of the child at school judged as troublesome by the teacher, and the impairment of the child in the school situation, the teacher-student relationship quality, teachers' sense of efficacy, and teachers' behavior management strategies.
* To examine the longer term effectiveness of the teacher training on primary and secondary outcomes.

STUDY DESIGN

The investigators will conduct a two-armed randomized controlled trial. Teachers will be randomly assigned (simple randomization) to (a) three sessions of brief teacher training with practice as usual (PAU), or (b) PAU only. Randomization will be done by a masked research assistant, who is not involved in the study, using a computer-generated randomized list.

The investigators will embed the trial in Dutch routine mental health care and Dutch school collaborations. Several school collaborations and at least two mental health care centers within the Netherlands will take part in the study.

In the intervention condition, primary and secondary outcome measures will be assessed before randomization (T0), one week after completion of the training (T1), and three months after T1 (T2). In the PAU condition primary and secondary outcome measures will be assessed before randomization (T0) and 8 weeks after T0 (T1). T2 does not apply for the PAU condition, as the brief teacher training can be provided in the PAU condition after T1 if needed. If T1 falls into a school vacation period, the measurement will be conducted during the first week following the school vacation.

TIME FRAME

November 2023: start recruitment, screening and inclusion of teachers and children, start running interventions.

November 2023-July 2025: ongoing contacts with participating mental health care organizations and school collaborations; recruitment, screening, and inclusion of teachers and children; run interventions and conduct measurements; supervision of therapists; fidelity checks; other project management activities.

July 2025-February 2028: data-checks and analysis, dissemination of results.

STUDY POPULATION

Participants will be Dutch elementary school teachers of children who display disruptive behaviors in the classroom in grade 1 to grade 8. The teachers work in a regular elementary school, a special elementary school or a special education school. The teachers (1) have been seeking help at school for handling the disruptive behavior of the child or (2) have a child in their classroom whose caretakers sought help at a mental health care institution for the disruptive behaviors of their child displayed at school. To enhance the generalizability of the results, the investigators aim to include a diverse sample of the Dutch population of children with disruptive behaviors, thus, from a broad age range (4-13 years), of both sexes, and all cultural and socioeconomic backgrounds

SAMPLE SIZE ASSESSMENT

In our prior randomized controlled study (with highly experienced therapists and no active interventions in the control group) the investigators found large short term effects on daily ratings of behavioral difficulties in the intervention group compared to waitlist (range of Cohen's d from .86 to .98;). For the current study the investigators estimated the short term effect of the brief teacher training as compared to PAU on our primary outcome measure to be at least small to medium (d = .35), as less experienced therapists will provide the training and children in both conditions can receive active interventions or support.

The investigators performed a power analysis (based on one primary outcome) using G\*Power software. Based on the effect size of d = .35, two groups and two repeated measures, with r = .60 between-measurement relation, a power of .80 and alpha = .05, the investigators will need 27 participants per group, resulting in a total of 54 participants. The investigators increased the sample size by 10% as the investigators will have nested data resulting in 30 participants per group, leading to a total of 60 participants.

TREATMENT OF SUBJECTS

Brief teacher training The brief teacher training consists of three sessions. The first two sessions will both take 120 minutes and the third session will take one hour. These three sessions will be spread over a maximum of six weeks. In between sessions, teachers are asked to read some materials and execute the plan as made during the session.

The teacher training program uses the behavioral techniques that were identified as effective for behavioral difficulties in a microtrial of our group and in the broader literature. The program combines stimulus control and contingency management techniques that, separately, reduced behaviors difficulties in the previous microtrial.

In the screening phase, the teacher indicates which four, daily occurring, target behaviors in which specific situations they prefer to address in the training. These behaviors and situations will be sent to the trainer.

The program consists of four steps. First, psycho-education will be provided on executive function problems and motivational issues that may occur in children with behavioral difficulties. Second, using functional analyses, the trainer and teacher will decide which of the available techniques are most tailored to the first target behavior in a specific situation that individual teachers experience with their student. Third, the trainer and teacher make an action plan for the target behavior in the specific situations in which these techniques are included and explained to the teacher. Fourth, the action plan will be practiced using role play and the teacher is instructed to implement this plan as soon as possible in the classroom. In the second session, the steps will be repeated for a second problem behavior. In the third session, trainer and teacher evaluate both plans and discuss how to maintain and generalize the behavioral techniques that proved to work.

Trainers who provide the brief teacher training will be psychologists with a master's degree in psychology or educational science, higher professional education level mental health care professionals with postmaster cognitive behavioral training, or other mental health care professionals from schools who (1) have experience in supporting teachers and (2) have knowledge about behavioral therapy and psychopathology, as demonstrated by a completed higher professional education course including (or in addition) at least 150 hours of education on behavioral therapy and psychopathology.

The trainers need to participate in a one-day training provided by two experts in behavioral parent- and teacher training for which they are asked to read the materials carefully and need to submit a video in which they demonstrate certain aspects of the training. They will receive feedback from the experts or researchers on this video.

Practice as usual PAU may include any support or treatment as regularly provided by mental health care centers, schools, school collaborations and/or other organizations, except from pharmacological treatment for children's behavioral difficulties and/or behavioral teacher training/support. PAU can also imply that there is no support or treatment. There are no criteria for professionals providing PAU.

METHODS

Demographic information about the child and caregivers will be collected with a self-composed questionnaire (reported by caregivers) with questions about age and gender of the child and caregivers, educational background of the caregivers, and (possible) mental health disorders of the child. Also the teacher answers a self-composed questionnaire with questions about their age, gender, and educational background.

MODERATORS

As candidate moderators of treatment effects, the investigators will investigate:

* Class size;
* Treatment expectancy of the teacher, as measured with the Dutch translation of the Credibility and expectancy-scale of the teacher-rated Credibility and Expectancy Questionnaire (CEQ);
* Parent-reported child reward responsivity and punishment sensitivity, as measured with the Reward Responsiveness Scale and the Punishment Sensitivity Schale of the Sensitivity to Punishment and Sensitivity to Reward Questionnaire for Children (SPSRQ-C);
* Differential susceptibility, as measured with the Dutch translation of the caregiver-rated Highly Sensitive Child scale (HSC);
* Emotion regulation, as measured with the emotion regulation subscale of the Behavior Rating Inventory of Executive Function (BRIEF-2);
* Severity of behavioral difficulties of the child in the classroom at T0 (Intensity scale of the Dutch translation of the Sutter-Eyberg Student Behavior Inventory-Revised; SESBI-R);
* Quality of the teacher-student relationship (TSRS) at T0;
* Teacher-reported frequency of the use of supportive and non-supportive management strategies (TSQ) at T0.

STUDY PROCEDURES

Teachers will be recruited through:

(1) School collaborations, where teachers seek help for behavioral difficulties of one of their students; (2) Mental healthcare centers, where the child's caregiver(s) and/or the involved clinicians may indicate that help for behavioral difficulties of the concerning child is needed at school.

1. Recruitment through school collaborations:

   Healthcare professionals who work in schools will inform teachers who are seeking help for behavioral difficulties of a child about the study. If a teacher is interested in participating in the study, the healthcare professional or the teacher gets into contact with the caregiver(s) of the child and inform the teacher about the study. Caregivers may include parents with parental rights or legal guardians of the child. Caregivers and teachers who are interested in participating in the study need to give consent to share their contact information with the researcher through the healthcare professional from the school. The researchers will use this contact information to further inform teachers and caregivers about the study. If a teacher wants to participate, and caregivers also agree, they are both asked to provide informed consent. Both caregivers (if present) of the child have to provide consent. If the child is 12 years old or older, the child also needs to give informed consent. By default teachers, caregivers, and children 12 years or older have at least 14 days to decide upon participation and ask the researchers any questions.
2. Recruitment through mental healthcare centers:

Clinicians at the participating mental healthcare centers, who are involved in the treatment of a child who displays behavioral difficulties at school, will inform the caregiver(s) of the child about the study. If the caregivers are interested in the participation of the teacher of their child in the study, the clinician or caregivers then gets into contact with the teacher and informs him or her about the study. Caregivers and teachers who are interested can give consent to share their contact information with the researcher through the clinician. The researchers will use this contact information to further inform teachers and caregivers about the study. If teachers want to participate, and the caregivers also agree, they are both asked to provide informed consent. Both caregivers (if present) of the child are asked to provide consent. If the child is 12 years old or older, the child will also be asked to give informed consent. By default, teachers, caregivers, and children 12 years or older have at least 14 days to decide upon participation and ask the researchers any questions.

For teachers, completing the questionnaires at T1 and T2 will take a maximum of 30 minutes. At T0, additional questionnaires will be administered for intended moderation analyses (extra 10 minutes, maximum 40 minutes in total). The phone calls to the teacher will take two to three minutes each, on four consecutive days per measurement occasion.

For caregivers, the questionnaires at T1 and T2 will take a maximum of 15 minutes. At T0, additional questionnaires will be administered for intended moderation analyses (extra 10 minutes, maximum 25 minutes in total).

STATISTICAL ANALYSIS

PRIMARY AND SECONDARY STUDY PARAMETERS

Data will be analyzed on an intention-to-treat basis. Differences in demographic variables between the study-arms will be analyzed with ANOVA's (continuous variables) or chi-squared tests (categorical variables). To examine the effects of the intervention on the primary and secondary outcomes the investigators will conduct multilevel analyses (mixed modeling). Mixed model analyses take missing data into account (Twisk et al., 2013). The investigators test a three-level multilevel model: outcomes (level 1), nested within children (level 2), nested within trainers (level 3). For trainers (level 3), the investigators will test whether including the level will result in a better model fit. If not, the level will not be taken into account.

MODERATORS

To assess the influence of candidate moderating variables on treatment effects, the investigators will include these variables as interaction effects in the multilevel analysis.

ETHICAL CONSIDERATIONS

The risk of any physical or mental harm caused by the study is very low and not to be expected higher than what may be expected in the daily practice of the teacher or in the daily school life of students. The investigators will exclusively use conventional methods and interventions. The study is embedded in mental healthcare settings and school collaborations.

The children will not directly be involved in the study. They will not be present during the brief teacher training sessions and all measures will be parent- or teacher-reported measures.

Teachers, caregivers and/or children 12 years old or older can decide to leave the study at any time for any reason if they wish to do so without any consequences.

To debrief teachers, caregivers, and children 12 years or older who wish to learn about the results of the study can request this information from the researchers after the study is finished. This concerns only information on group level. The investigators will inform teachers and caregivers about the possibility to ask for this information in the information letter.

ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION

HANDLING AND STORAGE OF DATA AND DOCUMENTS

Digital data, both raw and processed/analyzed data will be stored at a study specific highly secured folder within the Accare network. This study specific folder can only be accessed by researchers involved in this study.

All phone and questionnaire data and processed audio files (which are use to score treatment integrity, see below for more details) will be stored in one, pseudonymized file, that is accompanied by a 'readme' text file that contains a code book explaining the meaning of all variables. The file contains separate pages ('tabs') for all different outcome variables at all different timepoints. A separate logbook-file will be created documenting all decisions that will be made during the process from raw to published data. Old versions of all these documents will be stored, document names will contain their date to ensure version control.

Management of the data and access permissions are with the principal investigators of the research project.

Access permissions are controlled by the research project's principal investigators. Raw data containing identifiable information such as the separate log containing patient identification number and study code will be kept strictly separate from the processed data (in a separate folder) and can only be accessed by the supervisors, research assistants and PhD student. The processed, pseudonymized data will be available for fellow researchers and made available (restricted access) for re-use. Requests for re-use of data after the completion of the research project will be evaluated by principal investigators BvdH, TD, and ML who will check whether the research question falls within the scope of the informed consent.

After the research project has been completed (i.e., after data collection, data analysis and publishing of articles) all the anonymized (i.e., the link with identifiable information will be deleted) digital data will be transferred to a study specific folder for long-term storage within the Accare network. The folder can only be accessed by the principal investigators and by authorized personnel after approval of the Principal Investigators. This data storage environment allows for careful access management and is only accessible with username and password. Data storage is backed-up automatically daily.

All the research data will be stored for 15 years after the data collection has been completed (i.e. last research assessment for the last patient has been performed). Raw audio-files, that may contain personal information, will be stored for 15 years in an encrypted folder.

MONITORING AND QUALITY ASSURANCE

Not applicable.

INERVENTION INTEGRITY

Intervention integrity will be assessed using an adapted version of the procedures of Abikoff. All intervention sessions will be audiotaped. For every trainer, the first session will be checked and they will receive feedback on intervention integrity and fidelity by a cognitive behavioral therapist with extensive experience in behavioral teacher training.

Further, audiotapes of a subset of randomly selected sessions will be scored on intervention integrity and fidelity during the study by independent evaluators. In addition, after each session, the trainers have to complete a fidelity checklist in which they will be asked which topics were covered.

Eligibility criteria: Inclusion criteria for the teachers will be:

1. The teacher works in regular elementary education, special elementary education or special education (in Dutch: cluster 4);
2. The teacher indicates that the child displays at least four behavioral difficulties in the classroom on a daily basis that the teacher wants to target in the training (using a list of target disruptive behaviors (Hornstra et al., 2021; Van den Hoofdakker et al., 2007)).

Exclusion criterion for the teachers will be:

1. The teacher has received behavioral training or behavioral support aimed at remediating behavioral difficulties of the concerned child within the past year;
2. The teacher already participates in the study with another child.

Exclusion criteria for the children will be:

1. The child has a diagnosis of autism spectrum disorder (as reported by parents, we will not perform any measures to assess autism spectrum disorder);
2. The child currently receives pharmacological treatment for behavioral difficulties (e.g., methylphenidate).

Primary outcomes:
measure: Severity of four daily rated target behaviors in specific classroom situations
timeFrame: Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (T2, experimental arm only)
Secondary outcomes:
measure: Severity of daily the same four daily rated target behaviors in other classroom situations than the specified situation which is used as primary outcome (see primary outcome measure for details on administration)
timeFrame: Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (T2, experimental arm only)
measure: Teacher-reported severity of behavioral difficulties of the child in the classroom
timeFrame: Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (T2, experimental arm only)
measure: Teacher-reported number of child behavioral difficulties in the classroom that the teacher considers troublesome
timeFrame: Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (T2, experimental arm only)
measure: Teacher-reported child impairment at school associated with behavioral difficulties
timeFrame: Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (T2, experimental arm only)
measure: Teacher-reported quality of the teacher-student relationship
timeFrame: Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (T2, experimental arm only)].
measure: Teacher's sense of self-efficacy
timeFrame: Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (T2, experimental arm only)
measure: Teacher-reported frequency of supportive and non-supportive management strategies
timeFrame: Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (T2, experimental arm only
measure: Caregiver-reported severity of child behavioral difficulties at home
timeFrame: Before randomization (T0), one week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), three months after T1 (T2, experimental arm only)
Other outcomes:
measure: Teacher/school-reported history of mental healthcare/support.
timeFrame: Before randomization (T0)
measure: Teacher/school-reported use of mental health care or support for behavioral difficulties of the child in the classroom
timeFrame: One week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1)
measure: Caregiver-reported history of mental healthcare/support
timeFrame: Before randomization (T0)
measure: Caregiver-reported use of mental health care for behavioral difficulties of the child at home.
timeFrame: One week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1).
measure: Teachers satisfaction with the teacher training
timeFrame: One week after the brief training (experimental group only) (T1).
measure: Adverse reactions to the teacher training
timeFrame: One week after the brief training (experimental arm)/eight weeks after T0 (control arm) (T1), and at T2.
measure: Teacher/school-reported use of mental health care or support for behavioral difficulties of the child in the classroom
timeFrame: Three months after T1 (T2)
measure: Caregiver-reported use of mental health care for behavioral difficulties of the child at home
timeFrame: Three months after T1 (T2)
Locations:
city: Groningen
country: Netherlands
facility: Accare Child Study Center
Study officials:
affiliation: Accare child study centre; University Medical Center Groningen
name: Barbara van den Hoofdakker, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Free university of Amsterdam
name: Marjolein Luman, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Saskia van der Oord, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Accare child study centre; University Medical Center Groningen
name: Tycho Dekkers, Dr
role: PRINCIPAL_INVESTIGATOR
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