- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02518711
Effectiveness Study of a Behavioral Teacher Program Targeting ADHD Symptoms
A Randomized Controlled Trial Into the Effectiveness of a Behavioral Teacher Program Targeting ADHD Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Behavioral teacher program
The behavioral teacher program was used by the participant's teacher in the classroom during 18 weeks.
|
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
|
|
No Intervention: Control group
Children within the control group did not receive the behavioral teacher program but were allowed to receive regular care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Strengths and Weaknesses of ADHD-symptoms and Normal Behavior Scale (SWAN; Young, Levi, Martin, & Hay, 2009)
Time Frame: 6 weeks and 18 weeks after baseline assessment
|
The teacher and parent version of the SWAN were used
|
6 weeks and 18 weeks after baseline assessment
|
|
Change from Baseline in Strengths and Difficulties Questionnaire (SDQ; Van Widenfelt, Goedhart, Treffers, & Goodman, 2003)
Time Frame: 6 weeks and 18 weeks after baseline assessment
|
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
|
6 weeks and 18 weeks after baseline assessment
|
|
Change from Baseline in hyperactivity during school hours using Actigraphy (Cambridge Neurotechnology, 2008)
Time Frame: 6 weeks and 18 weeks after baseline assessment
|
It concerned an actigraph worn on the wrist of the non-dominated hand during 5 school days
|
6 weeks and 18 weeks after baseline assessment
|
|
Change from Baseline in Disruptive Classroom Behavior measured by the Classroom Observation Code (COC; Abikoff, Gittelman, & Klein, 1980)
Time Frame: 6 weeks and 18 weeks after baseline assessment
|
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
|
6 weeks and 18 weeks after baseline assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Social Skills Scale of the Social Skills Rating Scale (SSRS; Merrell & Popinga, 1994)
Time Frame: 6 weeks and 18 weeks after baseline assessment
|
The teacher and parent version of the SSRS were used
|
6 weeks and 18 weeks after baseline assessment
|
|
Change from Baseline in Spence Children's Anxiety Scale (SCAS)
Time Frame: 6 weeks and 18 weeks after baseline assessment
|
SCAS is a self-report administered to the child
|
6 weeks and 18 weeks after baseline assessment
|
|
Change from Baseline in Sociometric Measure (Bukowski, Cillessen, & Velasquez, 2012)
Time Frame: 6 weeks and 18 weeks after baseline assessment
|
The sociometric measure includes both a peer nomination and a peer rating scale
|
6 weeks and 18 weeks after baseline assessment
|
|
Change from Baseline in Performance on Dutch Reading Test (Drie-Minuten Toets; Verhoeven, 1995)
Time Frame: 6 weeks and 18 weeks after baseline assessment
|
6 weeks and 18 weeks after baseline assessment
|
|
|
Change from Baseline in Performance on Dutch Writing Test (PI-dictee; Geelhoed & Reitsma, 2000)
Time Frame: 6 weeks and 18 weeks after baseline assessment
|
6 weeks and 18 weeks after baseline assessment
|
|
|
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
|
6 weeks and 18 weeks after baseline assessment
|
|
|
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)
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
|
Only teachers in the intervention group needed to fill in this rating scale
|
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
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- CambridgeNeurotechnology. The Actiwatch User Manual. Cambridge, 2008.
- 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.
- 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.
- De Vos T. Tempo-Test-Rekenen. Handleiding. [Tempo Test Arithmetic. Manual]. Nijmegen: Berkhout; 1992.
- Verhoeven L. Drie Minuten Toets Handleiding.[Three Minutes Test Manual]. Arnhem, The Netherlands: CITO. 1995.
- Geelhoed J, Reitsma P. PI-dictee. Handleiding. Lisse: PI Research Duivendrecht, Swets & Zeitlinger B.V.; 2000.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- METc VUmc 2011/196
- 5930790 (Other Grant/Funding Number: KPZ)
- 20110028 (Other Grant/Funding Number: NSGK)
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