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. 2023 Mar 27;2023(3):CD009885. doi: 10.1002/14651858.CD009885.pub3

Kolko 1999.

Study characteristics
Methods Randomised, placebo‐controlled, cross‐over trial with 2 possible drug interventions and placebo, as well as 2 possible psychological interventions:
  • MPH at 0.3 mg/kg

  • MPH at 0.6 mg/kg

  • placebo


and
  • behaviour modification

  • no behavioural modification

Participants Number of participants screened: 70
Number of participants included: 22 (all boys)
Number of participants followed up: 16
Number of withdrawals: 6
Diagnosis of ADHD: DSM‐III‐R (subtypes not stated)
Age: mean 9.6 years (range 6.9‐12.9)
IQ: not stated
MPH‐naive: not stated
Ethnicity: African American (75%)
Country: USA
Setting: "partial hospitalisation" summer treatment programme
Comorbidity: CD (44%), ODD (56%), anxiety disorder (18.8%), major depressive disorder (11.5%), dysthymia (6%), intermittent explosive disorder (6%), developmental articulation disorder (6%), asthma (12.5%)
Comedication: not stated
Other sociodemographics: 3 lived with 1 or both parents, 6 lived with grandparents, 1 lived with an aunt, 4 lived with non‐relatives, 2 lived with foster mother. 44% of families received welfare
Inclusion criteria
  • Not stated


Exclusion criteria
  • Not stated

Interventions Participants were randomly assigned to different possible drug condition orders of 0.3 mg/kg and 0.6 mg/kg MPH and placebo
Mean MPH dosage: not stated
Administration schedule: 8:00 am and 11:30 am to 12.00 pm
Duration of each medication condition: 1 day. Each medication condition was administered once per week for a total of 6 days during the trial
Washout before trial initiation: 2 weeks
Medication‐free period between interventions: no
Titration period: none
Treatment compliance: not stated
Behavioural intervention: behaviour modification and no behaviour modification were alternated on a weekly basis for a total of 3 weeks per condition
Outcomes ADHD symptoms
  • Abbreviated IOWA CRS, which includes an Inattentive/Overactive subscale and an Oppositional Defiant subscale


Non‐serious AEs
  • Barkley Stimulant Side Effects Rating Scale. Adapted by changing the rating scale to include only 4 points rather than 9 points

Notes Sample calculation: not stated
Ethics approval: not stated
Key conclusions of trial authors
  • MPH and behaviour modification had certain unique, main and incremental effects that extend findings supporting their combination and suggest that integrated studies should evaluate multiple dimensions of functioning in novel settings

  • Incorporation of other intervention components in combined treatments may be warranted to enhance clinical efficacy


Comments from review authors
  • Barkley Stimulant Side Effects Rating Scale was adapted by changing the rating scale to include only 4 points (rather than 9 points) after pilot‐testing. Therefore, we cannot be sure whether the scale is still valid

  • Limitations: the number of participants studied was small, and only 22 of 70 screened met trial eligibility criteria


Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no
Any withdrawals due to AEs: yes, 2
Funding source: not declared
Email correspondence with trial author: January 2014. We were unable to obtain additional data (Nilausen 2014 [pers comm])
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Each MPH condition was administered once per week for a total of 6 days during the trial, and behaviour modification and no behaviour modification were alternated on a weekly basis, for a total of 3 weeks per condition. Thus, daily MPH conditions were crossed with 2, weekly behavioural intervention conditions
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias)
All outcomes Low risk It is stated: "MPH or placebo was placed in identical opaque capsules"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias)
All outcomes High risk Not stated
Selection bias: exclusion of 2 participants with challenging behaviour
Selective reporting (reporting bias) Unclear risk No protocol available