search
Back to results

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
VU University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring symptoms of ADHD

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

    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
    search

    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