NCT02518711

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
Last Updated

August 10, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

August 5, 2015

Last Update Submit

August 7, 2015

Conditions

Keywords

symptoms of ADHD

Outcome Measures

Primary Outcomes (4)

  • 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

    6 weeks and 18 weeks after baseline assessment

  • 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

    6 weeks and 18 weeks after baseline assessment

  • 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

    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)

    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 Outcomes (7)

  • Change from Baseline in Social Skills Scale of the Social Skills Rating Scale (SSRS; Merrell & Popinga, 1994)

    6 weeks and 18 weeks after baseline assessment

  • Change from Baseline in Spence Children's Anxiety Scale (SCAS)

    6 weeks and 18 weeks after baseline assessment

  • Change from Baseline in Sociometric Measure (Bukowski, Cillessen, & Velasquez, 2012)

    6 weeks and 18 weeks after baseline assessment

  • Change from Baseline in Performance on Dutch Reading Test (Drie-Minuten Toets; Verhoeven, 1995)

    6 weeks and 18 weeks after baseline assessment

  • Change from Baseline in Performance on Dutch Writing Test (PI-dictee; Geelhoed & Reitsma, 2000)

    6 weeks and 18 weeks after baseline assessment

  • +2 more secondary outcomes

Study Arms (2)

Behavioral teacher program

EXPERIMENTAL

The behavioral teacher program was used by the participant's teacher in the classroom during 18 weeks.

Behavioral: Behavioral Teacher Program

Control group

NO INTERVENTION

Children within the control group did not receive the behavioral teacher program but were allowed to receive regular care

Interventions

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

Behavioral teacher program

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • 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.

    PMID: 18322790BACKGROUND
  • 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.

    PMID: 16328743BACKGROUND
  • 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.

    PMID: 10591283BACKGROUND
  • 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.

    PMID: 1564021BACKGROUND
  • 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.

    PMID: 14702231BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 23216421BACKGROUND
  • 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.

    PMID: 19455417BACKGROUND
  • 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.

    PMID: 8190971BACKGROUND
  • CambridgeNeurotechnology. The Actiwatch User Manual. Cambridge, 2008.

    BACKGROUND
  • 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.

    PMID: 7410654BACKGROUND
  • 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.

    BACKGROUND
  • De Vos T. Tempo-Test-Rekenen. Handleiding. [Tempo Test Arithmetic. Manual]. Nijmegen: Berkhout; 1992.

    BACKGROUND
  • Verhoeven L. Drie Minuten Toets Handleiding.[Three Minutes Test Manual]. Arnhem, The Netherlands: CITO. 1995.

    BACKGROUND
  • Geelhoed J, Reitsma P. PI-dictee. Handleiding. Lisse: PI Research Duivendrecht, Swets & Zeitlinger B.V.; 2000.

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jaap Oosterlaan, PhD

    VU University of Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 10, 2015

Study Start

September 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 10, 2015

Record last verified: 2015-08