Condition category
Mental and Behavioural Disorders
Date applied
13/12/2017
Date assigned
18/01/2018
Last edited
15/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

ubbcluj.ro

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

Publication citations

Additional files

Editorial Notes