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. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

Klein 2004.

Methods Randomised controlled trial parallel study comparing:

  1. Methylphenidate alone (MPH)

  2. Methylphenidate and multimodal psychosocial treatment (MPH + MPT)

  3. Methylphenidate and attention control treatment (MPH + ACT)
Participants Number of participants screened: 332
Number of participants included: 129
Number of participants randomised to each arm: MPH = 34; MPH + MPT = 34; MPH + ACT = 35
Number of withdrawals in each arm: MPH: 10; MPH + MPT: 6; MPH + ACT: 6
Diagnosis of ADHD: DSM‐III‐R
Age: mean 8.2 (SD 0.8) years (range: 7.0‐9.9)
IQ: mean WISC IQs were full scale, 109.5 (SD 14.5); verbal, 108.5 (SD 4.0); and performance, 108.7 (SD 15.0)
Sex: 93% males, 7% females
Methylphenidate‐naïve: 79.6%
Ethnicity: 84% white, 13% African American, 2% Hispanic, and 1% other
Country: USA and Canada
Comorbidity: 55 (53.4%) ODD, 31 (30%) had 1‐2 symptoms of CD. 17 (16.5%) had an anxiety disorder (simple phobia, overanxious disorder, separation anxiety disorder), 4 (3.9%) had major depression
Comedication: not stated
Sociodemographics: 84 (81.2%) children lived with both parents, 13 (12.6%) with 1 parent (in all but one instance, the mother), and 6 (5.8%) with their mother and stepfather. Mean socioeconomic status was 2.5 SD 0.9 (range 1‐5) (Myers 1968). There were no significant difference in baseline demographics between the 2 groups
Inclusion criteria

  1. Children had to have a diagnosis of ADHD based on a parent interview with the Diagnostic Interview Schedule for Children (DISC‐P2) (Shaffer 1996) conducted by clinical psychologists confirmed by a child psychiatrist based on a comprehensive clinical interview with the child and parent and teacher reports

  2. On 2 separate occasions, children had to receive a mean teacher rating of ≥ 1.5 on the Hyperactivity Factor or Hyperkinesis Index of the Conners Teachers Rating Scale (CTRS) (Goyette 1978)

  3. Children had to be medication free for ≥ 2 weeks before evaluation

  4. Normal IQs (i.e. WISC‐R ≥ 85)

  5. Living with ≥ 1 parent

  6. Have telephone access

  7. Children had to derive meaningful benefit from the treatment without significant side effects

  8. Methylphenidate treatment must not incur cognitive decrement in the children


Exclusion criteria

  1. Diagnosable neurological disorders

  2. Psychosis

  3. Significant medical illness

  4. Current physical or sexual abuse

  5. Chronic tic disorder or Tourette disorder

  6. A DSM‐III‐R developmental reading or arithmetic disorder, defined as a standard score in reading or mathematics on the Kaufmann Test of Educational Achievement of 85 or less (i.e. ≥ 1 SD below the population mean) and ≥ 15 points (1 SD) below full‐scale IQ (Halperin 1984)

  7. A diagnosis of conduct disorder
Interventions Participants were randomly assigned to methylphenidate (MPH), methylphenidate and multimodal psychosocial treatment (MPH + MPT) or methylphenidate and attention control psychosocial treatment (MPH + ACT). Participants were balanced for ethnicity, sex, IQ, and oppositional defiant disorder. Assignment was done in blocks of 4 to enable group treatment components
Mean methylphenidate dosage: year 1: MPH = 35.8 (SD 8.5) mg, MPH + MPT = 35.6 (SD 9.4) mg, MPH + ACT = 38.4 (SD 8.5) mg. Year 2: MPH = 38.0 (SD 12.6) mg, MPH + MPT = 41.0 (SD 11.2) mg, MPH + ACT = 38.4 (SD 8.3) mg
Administration schedule: 8 am, noon, 4 pm
Duration of intervention: 2 years
Titration period: 5 weeks duration before randomisation
Treatment compliance: the percentage of positive Ritalin acid assays was 87%, without differences between groups. Medication compliance was addressed by counting returned pills
Outcomes Non‐serious adverse events:
Children's Depression Inventory (CDI) (Kovacs 1992)
Piers‐Harris Children's Self‐Concept Scale (Amato 1984)
Before every visit, teachers were called to obtain information about the child's school performance. The sessions were used to assess vital signs (weight, height, pulse, blood pressure), side effects (reported by parent and child), and the child's overall condition
Notes Sample calculation: not stated
Ethics approval: not stated
Funding: supported by NIMH grants RO1 MH44848 (H.A.) and RO1 MH44842 (L.H.).
Vested interests: Dr Klein is a member of the ADHD Advisory Board of Shire Pharmaceutical Co.
Key conclusions of the study authors: in stimulant‐responsive young children with ADHD without learning and conduct disorders, there is no support for academic assistance and psychotherapy to enhance academic achievement or emotional adjustment. Significant short‐term improvements were maintained over 2 years
Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes