Psychotherapy, atomoxetine, or combined treatment for ADHD in childre

Not Applicable

Completed

• Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD); Mental and Behavioural Disorders; Disturbance of activity and attention

• Registration Number: ISRCTN92640175
• Lead Sponsor: Babes-Bolyai University

Brief Summary

2020 Results article in https://doi.org/10.1007/s10608-020-10157-6 (added 20/01/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-11-01
• Study Start: 2018-01-18
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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)<br> 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)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Parent-rated externalizing and internalizing symptoms assessed using the Child Behavioral Checklist (CBCL; Achenbach & Rescorla, 2001) at baseline and post-treatment (16 weeks)<br> 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)<br> 3. Teacher-rated externalizing and internalizing symptoms assessed using Teacher’s Report Form (TRF; Achenbach & Rescorla, 2001) at baseline and post-treatment (16 weeks)<br>