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Effectiveness Study of a Behavioral Teacher Program Targeting ADHD Symptoms

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ClinicalTrials.gov Identifier: NCT02518711
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Collaborators:
Stichting Kinderpostzegels Nederland
Nederlandse Stichting voor het Gehandicapte Kind, The Netherlands
Stichting Weeshuis der Doopsgezinden, The Netherlands
Stichting Zonnige Jeugd, The Netherlands
Information provided by (Responsible Party):
Betty Veenman, VU University of Amsterdam

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: Behavioral Teacher Program Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Into the Effectiveness of a Behavioral Teacher Program Targeting ADHD Symptoms
Study Start Date : September 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioral teacher program
The behavioral teacher program was used by the participant's teacher in the classroom during 18 weeks.
Behavioral: Behavioral Teacher Program
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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Change from Baseline in Performance on Dutch Reading Test (Drie-Minuten Toets; Verhoeven, 1995) [ Time Frame: 6 weeks and 18 weeks after baseline assessment ]
  5. 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. 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 ]
  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518711


Sponsors and Collaborators
VU University of Amsterdam
Stichting Kinderpostzegels Nederland
Nederlandse Stichting voor het Gehandicapte Kind, The Netherlands
Stichting Weeshuis der Doopsgezinden, The Netherlands
Stichting Zonnige Jeugd, The Netherlands
Investigators
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Principal Investigator: Jaap Oosterlaan, PhD VU University of Amsterdam
Publications:
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.
CambridgeNeurotechnology. The Actiwatch User Manual. Cambridge, 2008.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Betty Veenman, MSc, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT02518711    
Other Study ID Numbers: METc VUmc 2011/196
5930790 ( Other Grant/Funding Number: KPZ )
20110028 ( Other Grant/Funding Number: NSGK )
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015
Keywords provided by Betty Veenman, VU University of Amsterdam:
symptoms of ADHD
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders