Psychotherapy, atomoxetine, or combined treatment for ADHD in children

A comparative study of three types of treatment for Attention-Deficit/Hyperactivity Disorder in children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN92640175

Enrollment

Registered

2018-01-18

Start date

2007-01-01

Completion date

Unknown

Last updated

2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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-behavior

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Romania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026