Psychotherapy, atomoxetine, or combined treatment for ADHD in children

ISRCTN ISRCTN92640175
DOI https://doi.org/10.1186/ISRCTN92640175
Secondary identifying numbers 716/30.01.2008
Submission date
13/12/2017
Registration date
18/01/2018
Last edited
20/01/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Daniel David
Scientific

Republicii St., No. 37
Cluj-Napoca
400015
Romania

Phone +40 (0)264 434141
Email danieldavid@psychology.ro

Study information

Study designInterventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA comparative study of three types of treatment for Attention-Deficit/Hyperactivity Disorder in children
Study objectivesThe 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(s)1. The Ethics Committee of Babes-Bolyai University, 01/08/2006, ref: 30713
2. The National Agency for Medication, 30/01/2008, ref: 716
Health condition(s) or problem(s) studiedAttention-Deficit/Hyperactivity Disorder (ADHD)
InterventionRandomization 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 typeMixed
Primary outcome measure1. 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 measures1. 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 study start date01/08/2006
Completion date01/11/2008

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Years
Upper age limit11 Years
SexBoth
Target number of participants58 participants
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2007
Date of final enrolment01/07/2008

Locations

Countries of recruitment

  • Romania

Study participating centres

The Institute for the Advanced Studies of Psychotherapy and Applied Mental Health, Babeș-Bolyai University
Republicii St., No. 37
Cluj-Napoca
400015
Romania
The Clinic of Child and Adolescent Psychiatry
Ospătăriei St.
Cluj-Napoca
400660
Romania

Sponsor information

Babes-Bolyai University
University/education

No. 1, Kogalniceanu Street
Cluj-Napoca
-
Romania

Website ubbcluj.ro
ROR logo "ROR" https://ror.org/02rmd1t30

Funders

Funder type

Research council

National Council for Research (CEEX No. 78/2006)

No information available

Results and Publications

Intention to publish date31/12/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planStudy 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 planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 02/10/2020 20/01/2022 Yes No

Editorial Notes

20/01/2022: Publication reference added.