Plain English Summary
Background and study aims
Attention-Deficit/Hyperactivity Disorder (ADHD) is a prevalent condition in youths, with symptoms that include inattentiveness, hyperactivity and impulsiveness. It is associated with a significant impact on functioning and high costs. The aim of this study is to compare the effectiveness of a combined treatment (CBT/REBT + ATX) with two reference treatments (CBT/REBT and ATX) for ADHD symptoms in children.
Who can participate?
Children aged 6 to 11 with ADHD
What does the study involve?
Participants are randomly allocated to one of three groups. Participants in the psychotherapy group receive 16 weekly individual psychotherapy sessions, involving both parents and children, based on Cognitive Behavioral Therapy (CBT) and Rational Emotive Behavior Therapy (REBT) enhanced with one session of attention training delivered via virtual reality. Participants in the medication group receive atomoxetine (ATX) once daily. Participants in the combined group (ATX+ REBT/CBT) receive both medication and psychotherapy as previously described. The total duration of treatment is 16 weeks. Clinical psychologists and multiple assessors (parents, teachers) assess the participants' ADHD symptoms before and after treatment.
What are the possible benefits and risks of participating?
Possible benefits include free treatment for ADHD which is not covered in Romania by health insurance. Risks involving adverse medication effects, which are monitored by psychiatrists.
Where is the study run from?
1. The Institute for the Advanced Studies of Psychotherapy and Applied Mental Health, Babeș-Bolyai University (Romania)
2. The Clinic of Child and Adolescent Psychiatry (Romania)
When is the study starting and how long is it expected to run for?
August 2006 to November 2008
Who is funding the study?
National Council for Research (Romania)
Who is the main contact?
Prof. Daniel David
danieldavid@psychology.ro
Trial website
Contact information
Type
Scientific
Primary contact
Prof Daniel David
ORCID ID
Contact details
Republicii St.
No. 37
Cluj-Napoca
400015
Romania
+40 (0)264 434141
danieldavid@psychology.ro
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
716/30.01.2008
Study information
Scientific title
A comparative study of three types of treatment for Attention-Deficit/Hyperactivity Disorder in children
Acronym
Study hypothesis
The primary aim is to compare the efficacy of the combined treatment (CBT/REBT + ATX) with two reference treatments (CBT/REBT and ATX) in a superiority format for ADHD symptoms in children.
Ethics approval
1. The Ethics Committee of Babes-Bolyai University, 01/08/2006, ref: 30713
2. The National Agency for Medication, 30/01/2008, ref: 716
Study design
Interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Attention-Deficit/Hyperactivity Disorder (ADHD)
Intervention
Randomization was done using a random number generator (www.random.org). Participants were randomly assigned to one of the three treatment groups:
1. Psychotherapy (cognitive-behavioral therapy/rational emotive behavior therapy CBT/REBT)
Participants in the psychotherapy condition received 16 weekly individual psychotherapy sessions, involving both parents and children. The protocol was based on Cognitive Behavioral Therapy (CBT) and Rational Emotive Behavior Therapy (REBT) enhanced with one session of attention training delivered via virtual reality (VR).
2. Medication (atomoxetine ATX)
Participants in the medication condition received atomoxetine (ATX) once daily in the morning, with an initial dose of 0.5 mg/kg/day, increased weekly (maximum increase 1.8 mg/kg/day).
3. Combined treatment (ATX+ REBT/CBT)
Participants in the combined group (ATX+ REBT/CBT) received both medication and psychotherapy as previously described.
The total duration of treatment was 16 weeks. Blinded clinical psychologists and multiple assessors (parents, teachers) assessed ADHD symptoms both at pretreatment and posttreatment.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
1. Clinician-based interviews on ADHD symptoms and impairment. ADHD diagnosis was assessed using the Structured Clinical Interview for DSM-IV Childhood Diagnoses (KID-SCID; Hien et al., 1994), while impairment was assessed using the Global Assessment of Functioning (GAF; APA, 1994); both conducted at baseline and post-treatment (16 weeks)
2. Parent-rated ADHD total symptoms, inattention and hyperactivity symptoms, measured using the ADHD-rating scale IV-Parent Version (ADHD-RS IV; DuPaul, Power, Anastopoulos, & Reid, 1998) at baseline and post-treatment (16 weeks)
Secondary outcome measures
1. Parent-rated externalizing and internalizing symptoms assessed using the Child Behavioral Checklist (CBCL; Achenbach & Rescorla, 2001) at baseline and post-treatment (16 weeks)
2. Teacher-rated ADHD total symptoms, inattention and hyperactivity symptoms assessed using The ADHD-rating scale IV-Teacher Version (ADHD-RS IV; DuPaul et al., 1998) at baseline and post-treatment (16 weeks)
3. Teacher-rated externalizing and internalizing symptoms assessed using Teacher’s Report Form (TRF; Achenbach & Rescorla, 2001) at baseline and post-treatment (16 weeks)
Overall trial start date
01/08/2006
Overall trial end date
01/11/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged between 6 and 11 years old
2. Diagnosed with ADHD by a child psychiatrist and/or certified psychologist
3. Attending elementary school
4. With sufficient understanding of the Romanian language
5. With an IQ score of at least 80 on Colored Raven Matrices
6. No previous treatment for ADHD received
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
58 participants
Participant exclusion criteria
1. Mental retardation
2. Neurodevelopmental disorders (autism spectrum disorders)
3. Severe depression
4. Psychotic disorders
5. Intolerance to atomoxetine
6. Body weight < 20 kg
7. Any severe medical conditions or clinically significant laboratory or ECG abnormalities
Recruitment start date
01/01/2007
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Romania
Trial participating centre
The Institute for the Advanced Studies of Psychotherapy and Applied Mental Health, Babeș-Bolyai University
Republicii St., No. 37
Cluj-Napoca
400015
Romania
Trial participating centre
The Clinic of Child and Adolescent Psychiatry
Ospătăriei St.
Cluj-Napoca
400660
Romania
Sponsor information
Organisation
Babes-Bolyai University
Sponsor details
No. 1
Kogalniceanu Street
Cluj-Napoca
-
Romania
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
National Council for Research (CEEX No. 78/2006)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Study protocol and detailed plan of analysis will be available upon request from the contact person, after the publication of the data. Planned publication of the study results in a high-impact peer reviewed journal in 2018.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Daniel David (danieldavid@psychology.ro). Data will be shared upon reasonable request after the publication of the data.
Intention to publish date
31/12/2018
Participant level data
Available on request
Basic results (scientific)
Publication list