Clinical trial NCT02518711: 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
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: symptoms of ADHD
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: Stichting Kinderpostzegels Nederland
name: Nederlandse Stichting voor het Gehandicapte Kind, The Netherlands
name: Stichting Weeshuis der Doopsgezinden, The Netherlands
name: Stichting Zonnige Jeugd, The Netherlands
First posted: 2015-08-10
Enrollment: 114
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Change from Baseline in Strengths and Weaknesses of ADHD-symptoms and Normal Behavior Scale (SWAN; Young, Levi, Martin, & Hay, 2009)
timeFrame: 6 weeks and 18 weeks after baseline assessment
measure: Change from Baseline in Strengths and Difficulties Questionnaire (SDQ; Van Widenfelt, Goedhart, Treffers, & Goodman, 2003)
timeFrame: 6 weeks and 18 weeks after baseline assessment
measure: Change from Baseline in hyperactivity during school hours using Actigraphy (Cambridge Neurotechnology, 2008)
timeFrame: 6 weeks and 18 weeks after baseline assessment
measure: Change from Baseline in Disruptive Classroom Behavior measured by the Classroom Observation Code (COC; Abikoff, Gittelman, & Klein, 1980)
timeFrame: 6 weeks and 18 weeks after baseline assessment
Secondary outcomes:
measure: Change from Baseline in Social Skills Scale of the Social Skills Rating Scale (SSRS; Merrell & Popinga, 1994)
timeFrame: 6 weeks and 18 weeks after baseline assessment
measure: Change from Baseline in Spence Children's Anxiety Scale (SCAS)
timeFrame: 6 weeks and 18 weeks after baseline assessment
measure: Change from Baseline in Sociometric Measure (Bukowski, Cillessen, & Velasquez, 2012)
timeFrame: 6 weeks and 18 weeks after baseline assessment
measure: Change from Baseline in Performance on Dutch Reading Test (Drie-Minuten Toets; Verhoeven, 1995)
timeFrame: 6 weeks and 18 weeks after baseline assessment
measure: Change from Baseline in Performance on Dutch Writing Test (PI-dictee; Geelhoed & Reitsma, 2000)
timeFrame: 6 weeks and 18 weeks after baseline assessment
measure: Change from Baseline in Performance on Dutch Arithmetic Test (Tempo-Test Rekenen; De Vos, 1992)
timeFrame: 6 weeks and 18 weeks after baseline assessment
measure: 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)
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: VU University of Amsterdam
name: Jaap Oosterlaan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.