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. 2019 Jun 21;2019(6):CD008223. doi: 10.1002/14651858.CD008223.pub3

NCT01019252.

Methods Design: RCT
Number of arms: two
Participants Country: USA
Sample size calculation: not reported
Target sample size: 66
Eligible age: age 14 to 18 years
Eligible sex: all
Inclusion criteria:
  1. age 14 to 18 years

  2. in high school

  3. principal diagnosis of ADHD

  4. stable prescription of medications for ADHD

  5. childhood onset of ADHD

  6. clinically significant ADHD symptoms


Exclusion criteria:
  1. comorbidity of: organic mental disorders; active substance abuse or dependence; diagnosis of conduct disorder; mental retardation or pervasive developmental disorder

  2. active suicidality

  3. other condition interfering with consent or participation

  4. previous history of CBT therapy in adolescence

Interventions
  1. Group one: behavioural: compensatory executive skills training, cognitive behavioural therapy. Participants provided with education about ADHD and instruction in organisational skills, reducing distractibility, and adaptive thinking. Twelve weekly treatment sessions

  2. Group two: no intervention. Cross‐over design with the participants on the waiting list receiving CBTafter the four‐month assessment

Outcomes
  1. ADHD symptoms: ADHD‐RS, child‐ and parent‐rated; CGI scale, clinician‐rated

  2. Secondary symptoms of ADHD (e.g. mood)


Time of assessment: before randomisation, and at follow‐up, four months and eight months after randomisation
Notes Study ID:NCT01019252
Sponsorship source: R34MH083063, US NIH Grant/Contract; DDTR B4‐TBI, National Institute of Mental Health
Study start date: October 2009
Study end date: August 2012
Status: completed
Declared conflict of interest: not reported
Comments: none
Registrant's name: Steven A Safren
Institution: Massachusetts General Hospital
Address: not reported
Email: not reported
Telephone: not reported

ADHD: attention deficit hyperactivity disorder
 ADHD‐ RS: Attention Deficit Hyperactivity Disorder ‐ Rating Scal
 CBT: cognitive behavioural therapy
 CGI: Clincal Global Impressions 
 RCT: randomised controlled trial