Effectiveness Study of a Behavioral Teacher Program Targeting ADHD Symptoms
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavioral Teacher Program
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring symptoms of ADHD
Eligibility Criteria
Inclusion Criteria:
- sub-threshold or clinical level of ADHD symptoms as observed by participant's teacher through the Dutch version of the Disruptive Behavior Disorders Rating Scale (Pelham, Gnagy, Greenslade, & Milich, 1992)
- at least one clinical and three sub-threshold ADHD symptoms as measured by the Teacher Telephone Interview (Holmes et al., 2004), a semi-structured interview which is based on the Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association, 2000)
Exclusion Criteria:
- (medication) treatment for ADHD at study entry or in preceding 6 months;
- neurological or severe physical condition
- IQ < 80 based on a short version of the Wechsler Intelligence Scale for Children (Block Design and Vocabulary; Legerstee, van der Reijden-Lakeman, Lechner-van der Noort, & Ferdinand, 2004; Hrabok, Brooks, Fay-McClymont, & Sherman, 2014)
- participant enrolled in a daily contingency management program or other teacher program targeting behavior or social problems at study entry or in the preceding month
- Maximum of 2 children per classroom and 5 classrooms per school (in order to limit teachers' burden and increase heterogeneity of teacher and classroom settings)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Behavioral teacher program
Control group
Arm Description
The behavioral teacher program was used by the participant's teacher in the classroom during 18 weeks.
Children within the control group did not receive the behavioral teacher program but were allowed to receive regular care
Outcomes
Primary Outcome Measures
Change from Baseline in Strengths and Weaknesses of ADHD-symptoms and Normal Behavior Scale (SWAN; Young, Levi, Martin, & Hay, 2009)
The teacher and parent version of the SWAN were used
Change from Baseline in Strengths and Difficulties Questionnaire (SDQ; Van Widenfelt, Goedhart, Treffers, & Goodman, 2003)
The teacher and parent-version of the SDQ were administered, using the following subscales: ADHD, Conduct Problems, Internalizing Behavior (combining Emotional Symptoms and Peer Problems), and Impact On Daily Functioning
Change from Baseline in hyperactivity during school hours using Actigraphy (Cambridge Neurotechnology, 2008)
It concerned an actigraph worn on the wrist of the non-dominated hand during 5 school days
Change from Baseline in Disruptive Classroom Behavior measured by the Classroom Observation Code (COC; Abikoff, Gittelman, & Klein, 1980)
The observation was performed by well-trained psychology students not involved in treatment delivery. Each participant was observed twice on the same school day for 8 minutes, using the average score as outcome measure
Secondary Outcome Measures
Change from Baseline in Social Skills Scale of the Social Skills Rating Scale (SSRS; Merrell & Popinga, 1994)
The teacher and parent version of the SSRS were used
Change from Baseline in Spence Children's Anxiety Scale (SCAS)
SCAS is a self-report administered to the child
Change from Baseline in Sociometric Measure (Bukowski, Cillessen, & Velasquez, 2012)
The sociometric measure includes both a peer nomination and a peer rating scale
Change from Baseline in Performance on Dutch Reading Test (Drie-Minuten Toets; Verhoeven, 1995)
Change from Baseline in Performance on Dutch Writing Test (PI-dictee; Geelhoed & Reitsma, 2000)
Change from Baseline in Performance on Dutch Arithmetic Test (Tempo-Test Rekenen; De Vos, 1992)
Teacher's treatment fidelity averaged over 18 similar checklists (self-constructed), containing 13 items on a 3-point Likert scale regarding the use of each intervention element (0=not used or inadequate use, 1=adequate use, and 2=good use)
Only teachers in the intervention group needed to fill in this rating scale
Full Information
NCT ID
NCT02518711
First Posted
August 5, 2015
Last Updated
August 7, 2015
Sponsor
VU University of Amsterdam
Collaborators
Stichting Kinderpostzegels Nederland, Nederlandse Stichting voor het Gehandicapte Kind, The Netherlands, Stichting Weeshuis der Doopsgezinden, The Netherlands, Stichting Zonnige Jeugd, The Netherlands
1. Study Identification
Unique Protocol Identification Number
NCT02518711
Brief Title
Effectiveness Study of a Behavioral Teacher Program Targeting ADHD Symptoms
Official Title
A Randomized Controlled Trial Into the Effectiveness of a Behavioral Teacher Program Targeting ADHD Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VU University of Amsterdam
Collaborators
Stichting Kinderpostzegels Nederland, Nederlandse Stichting voor het Gehandicapte Kind, The Netherlands, Stichting Weeshuis der Doopsgezinden, The Netherlands, Stichting Zonnige Jeugd, The Netherlands
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study was to investigate the effectiveness of a behavioral teacher program addressing symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) in the classroom.
Detailed Description
Background:
Most behavioral teacher programs involve intensive and expensive teacher trainings by health care specialists, which may limit successful large-scale implementation. This behavioral program, on the contrary, involves a self-containing manual that does not require expert training in order to increase the likelihood of successful implementation (if proven effective). The aim was to investigate the program's effects on behavioral, socio-emotional and school functioning in primary school children.
Methods:
Children with ADHD symptoms were randomly assigned at school level to the intervention condition (receiving the program during 18 weeks) or control group (not receiving the program but who were allowed to receive care as usual).
Measures to assess program's effectiveness:
Strengths and Weaknesses of ADHD-symptoms and Normal Behavior,
Strengths and Difficulties Questionnaire
Social Skills Rating Scale
Spence Children's Anxiety Scale
Classroom Observation Code
Actigraphy
Sociometric measures (peer nomination and peer rating)
Dutch arithmetic test (Tempo-Test-Rekenen)
reading test (Drie-Minuten-Toets) and writing test (PI-dictee).
Additional measures:
Wechsler Intelligence Scale for Children (Block Design and Vocabulary; used to estimate IQ);
Sensitivity to Punishment and Sensitivity to Reward Questionnaire and several neuropsychological computer tasks
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
symptoms of ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral teacher program
Arm Type
Experimental
Arm Description
The behavioral teacher program was used by the participant's teacher in the classroom during 18 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Children within the control group did not receive the behavioral teacher program but were allowed to receive regular care
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Teacher Program
Intervention Description
This program was based on the evidence-based Summer Treatment Program (MTA Cooperative Group, 1999), involving psycho-education for the teacher and universal and individual behavioral techniques that focused on classroom structure and contingency management
Primary Outcome Measure Information:
Title
Change from Baseline in Strengths and Weaknesses of ADHD-symptoms and Normal Behavior Scale (SWAN; Young, Levi, Martin, & Hay, 2009)
Description
The teacher and parent version of the SWAN were used
Time Frame
6 weeks and 18 weeks after baseline assessment
Title
Change from Baseline in Strengths and Difficulties Questionnaire (SDQ; Van Widenfelt, Goedhart, Treffers, & Goodman, 2003)
Description
The teacher and parent-version of the SDQ were administered, using the following subscales: ADHD, Conduct Problems, Internalizing Behavior (combining Emotional Symptoms and Peer Problems), and Impact On Daily Functioning
Time Frame
6 weeks and 18 weeks after baseline assessment
Title
Change from Baseline in hyperactivity during school hours using Actigraphy (Cambridge Neurotechnology, 2008)
Description
It concerned an actigraph worn on the wrist of the non-dominated hand during 5 school days
Time Frame
6 weeks and 18 weeks after baseline assessment
Title
Change from Baseline in Disruptive Classroom Behavior measured by the Classroom Observation Code (COC; Abikoff, Gittelman, & Klein, 1980)
Description
The observation was performed by well-trained psychology students not involved in treatment delivery. Each participant was observed twice on the same school day for 8 minutes, using the average score as outcome measure
Time Frame
6 weeks and 18 weeks after baseline assessment
Secondary Outcome Measure Information:
Title
Change from Baseline in Social Skills Scale of the Social Skills Rating Scale (SSRS; Merrell & Popinga, 1994)
Description
The teacher and parent version of the SSRS were used
Time Frame
6 weeks and 18 weeks after baseline assessment
Title
Change from Baseline in Spence Children's Anxiety Scale (SCAS)
Description
SCAS is a self-report administered to the child
Time Frame
6 weeks and 18 weeks after baseline assessment
Title
Change from Baseline in Sociometric Measure (Bukowski, Cillessen, & Velasquez, 2012)
Description
The sociometric measure includes both a peer nomination and a peer rating scale
Time Frame
6 weeks and 18 weeks after baseline assessment
Title
Change from Baseline in Performance on Dutch Reading Test (Drie-Minuten Toets; Verhoeven, 1995)
Time Frame
6 weeks and 18 weeks after baseline assessment
Title
Change from Baseline in Performance on Dutch Writing Test (PI-dictee; Geelhoed & Reitsma, 2000)
Time Frame
6 weeks and 18 weeks after baseline assessment
Title
Change from Baseline in Performance on Dutch Arithmetic Test (Tempo-Test Rekenen; De Vos, 1992)
Time Frame
6 weeks and 18 weeks after baseline assessment
Title
Teacher's treatment fidelity averaged over 18 similar checklists (self-constructed), containing 13 items on a 3-point Likert scale regarding the use of each intervention element (0=not used or inadequate use, 1=adequate use, and 2=good use)
Description
Only teachers in the intervention group needed to fill in this rating scale
Time Frame
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 weeks after start of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
sub-threshold or clinical level of ADHD symptoms as observed by participant's teacher through the Dutch version of the Disruptive Behavior Disorders Rating Scale (Pelham, Gnagy, Greenslade, & Milich, 1992)
at least one clinical and three sub-threshold ADHD symptoms as measured by the Teacher Telephone Interview (Holmes et al., 2004), a semi-structured interview which is based on the Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association, 2000)
Exclusion Criteria:
(medication) treatment for ADHD at study entry or in preceding 6 months;
neurological or severe physical condition
IQ < 80 based on a short version of the Wechsler Intelligence Scale for Children (Block Design and Vocabulary; Legerstee, van der Reijden-Lakeman, Lechner-van der Noort, & Ferdinand, 2004; Hrabok, Brooks, Fay-McClymont, & Sherman, 2014)
participant enrolled in a daily contingency management program or other teacher program targeting behavior or social problems at study entry or in the preceding month
Maximum of 2 children per classroom and 5 classrooms per school (in order to limit teachers' burden and increase heterogeneity of teacher and classroom settings)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaap Oosterlaan, PhD
Organizational Affiliation
VU University of Amsterdam
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
18322790
Citation
Durlak JA, DuPre EP. Implementation matters: a review of research on the influence of implementation on program outcomes and the factors affecting implementation. Am J Community Psychol. 2008 Jun;41(3-4):327-50. doi: 10.1007/s10464-008-9165-0.
Results Reference
background
PubMed Identifier
16328743
Citation
Han SS, Weiss B. Sustainability of teacher implementation of school-based mental health programs. J Abnorm Child Psychol. 2005 Dec;33(6):665-79. doi: 10.1007/s10802-005-7646-2.
Results Reference
background
PubMed Identifier
10591283
Citation
A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. The MTA Cooperative Group. Multimodal Treatment Study of Children with ADHD. Arch Gen Psychiatry. 1999 Dec;56(12):1073-86. doi: 10.1001/archpsyc.56.12.1073.
Results Reference
background
PubMed Identifier
1564021
Citation
Pelham WE Jr, Gnagy EM, Greenslade KE, Milich R. Teacher ratings of DSM-III-R symptoms for the disruptive behavior disorders. J Am Acad Child Adolesc Psychiatry. 1992 Mar;31(2):210-8. doi: 10.1097/00004583-199203000-00006. Erratum In: J Am Acad Child Adolesc Psychiatry 1992 Nov;31(6):1177.
Results Reference
background
PubMed Identifier
14702231
Citation
Holmes J, Lawson D, Langley K, Fitzpatrick H, Trumper A, Pay H, Harrington R, Thapar A. The Child Attention-Deficit Hyperactivity Disorder Teacher Telephone Interview (CHATTI): reliability and validity. Br J Psychiatry. 2004 Jan;184:74-8. doi: 10.1192/bjp.184.1.74.
Results Reference
background
Citation
Legerstee JS, van der Reijden-Lakeman IA, Lechner-van der Noort MG, Ferdinand RF. Bruikbaarheid verkorte versie wisc-rn in de kinderpsychiatrie. Kind en adolescent. 2004;25(4):178-82. doi: 10.1007/BF03060926.
Results Reference
background
PubMed Identifier
23216421
Citation
Hrabok M, Brooks BL, Fay-McClymont TB, Sherman EM. Wechsler Intelligence Scale for Children-fourth edition (WISC-IV) short-form validity: a comparison study in pediatric epilepsy. Child Neuropsychol. 2014;20(1):49-59. doi: 10.1080/09297049.2012.741225. Epub 2012 Dec 10.
Results Reference
background
PubMed Identifier
19455417
Citation
Young DJ, Levy F, Martin NC, Hay DA. Attention deficit hyperactivity disorder: a Rasch analysis of the SWAN Rating Scale. Child Psychiatry Hum Dev. 2009 Dec;40(4):543-59. doi: 10.1007/s10578-009-0143-z. Epub 2009 May 20.
Results Reference
background
PubMed Identifier
8190971
Citation
Merrell KW, Popinga MR. The alliance of adaptive behavior and social competence: an examination of relationship between the scales of Independent Behavior and the Social Skills Rating System. Res Dev Disabil. 1994 Jan-Feb;15(1):39-47. doi: 10.1016/0891-4222(94)90037-x.
Results Reference
background
Citation
CambridgeNeurotechnology. The Actiwatch User Manual. Cambridge, 2008.
Results Reference
background
PubMed Identifier
7410654
Citation
Abikoff H, Gittelman R, Klein DF. Classroom observation code for hyperactive children: a replication of validity. J Consult Clin Psychol. 1980 Oct;48(5):555-65. doi: 10.1037//0022-006x.48.5.555. No abstract available.
Results Reference
background
Citation
Bukowski WM, Cillessen A, Velasquez A. Peer ratings. In: Laursen B, Little T, Card A, editors. Handbook of developmental research methods. New York: The Guilford Press; 2012. p. 211-28.
Results Reference
background
Citation
De Vos T. Tempo-Test-Rekenen. Handleiding. [Tempo Test Arithmetic. Manual]. Nijmegen: Berkhout; 1992.
Results Reference
background
Citation
Verhoeven L. Drie Minuten Toets Handleiding.[Three Minutes Test Manual]. Arnhem, The Netherlands: CITO. 1995.
Results Reference
background
Citation
Geelhoed J, Reitsma P. PI-dictee. Handleiding. Lisse: PI Research Duivendrecht, Swets & Zeitlinger B.V.; 2000.
Results Reference
background
PubMed Identifier
29593604
Citation
Veenman B, Luman M, Oosterlaan J. Moderators Influencing the Effectiveness of a Behavioral Teacher Program. Front Psychol. 2018 Mar 13;9:298. doi: 10.3389/fpsyg.2018.00298. eCollection 2018.
Results Reference
derived
PubMed Identifier
28744244
Citation
Veenman B, Luman M, Oosterlaan J. Further Insight into the Effectiveness of a Behavioral Teacher Program Targeting ADHD Symptoms Using Actigraphy, Classroom Observations and Peer Ratings. Front Psychol. 2017 Jul 11;8:1157. doi: 10.3389/fpsyg.2017.01157. eCollection 2017.
Results Reference
derived
Learn more about this trial
Effectiveness Study of a Behavioral Teacher Program Targeting ADHD Symptoms
We'll reach out to this number within 24 hrs