Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06127030
Status:
RECRUITING
Last Update Posted:
2023-12-18
First Post:
2023-11-07
Brief Title:
Brief Behavioral Teacher Training for Behavioral Difficulties
Sponsor:
Accare
Organization:
Accare
Study Overview
Official Title:
The Effectiveness of a Brief Behavioral Training for Teachers of Children With Behavioral Difficulties at School a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAINT-T
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 childrens behavioral difficulties in two biweekly 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 andor other organizations except from pharmacological treatment for childrens behavioral difficulties andor behavioral teacher trainingsupport PAU can also imply that there is no support or treatment
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 childrens behavioral difficulties in two biweekly 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 andor other organizations except from pharmacological treatment for childrens behavioral difficulties andor behavioral teacher trainingsupport PAU can also imply that there is no support or treatment
Detailed Description:
INTRODUCTION AND RATIONALE
Behavioral difficulties such as inattentive impulsive hyperactive oppositional andor 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 andor 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 childrens 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 teachers and childs 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 programs focus on tailoring program content to the individual problems that teachers andor 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 Cohens 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 GPower 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 masters 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 andor other organizations except from pharmacological treatment for childrens behavioral difficulties andor behavioral teacher trainingsupport 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 childs caregivers andor 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 caregivers 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 caregivers 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 ANOVAs 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 andor 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 processedanalyzed 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 projects 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 ie after data collection data analysis and publishing of articles all the anonymized ie 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 ie 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
Behavioral difficulties such as inattentive impulsive hyperactive oppositional andor 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 andor 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 childrens 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 teachers and childs 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 programs focus on tailoring program content to the individual problems that teachers andor 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 Cohens 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 GPower 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 masters 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 andor other organizations except from pharmacological treatment for childrens behavioral difficulties andor behavioral teacher trainingsupport 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 childs caregivers andor 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 caregivers 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 caregivers 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 ANOVAs 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 andor 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 processedanalyzed 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 projects 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 ie after data collection data analysis and publishing of articles all the anonymized ie 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PPO-RF-34 | OTHER_GRANT | PVO Researchfonds | None |