Methods |
Design: RCT |
Participants |
Country: USA Setting: six multisite outpatient clinics Sample size calculation: 576 participants required Sample size: 576 children Sex: 465 (81%) = boys, 111 (19%) = girls Age: range 7.0 to 9.9 years Ethnicity: white = 61%, African‐American = 20%, Hispanic = 8% Socioeconomic status: not reported IQ: below 80 excluded ADHD diagnosis:DSM‐IV, ADHD combined type ADHD medication: 97% received methylphenidate Comorbidity: anxiety disorder = 33.5%, conduct disorder = 14.3%, ODD = 39.9%, affective disorder = 3.8%, tic disorder = 10.9%, other = 2.2% such as bulimia, enuresis Medications for comorbid disorders: balanced between groups. Inclusion criteria:
boys and girls
7‐9.9 years of age (1st‐4th grades)
residing with primary caretakers for at least six months
meet dimensional criteria for hyperactivity on the basis of parent and teacher rating scales and full diagnostic criteria for ADHD combined type
Exclusion criteria:
currently in hospital (inability to obtain school assessments)
currently in another treatment study (confounding of assessments and treatments)
below 80 on WISC‐III Verbal IQ, Performance IQ or Full Scale IQ scores, and on Scales of Independent Behavior (insufficient ability to participate in psychosocial interventions)
bipolar disorder, psychosis, pervasive developmental disorder, severe obsessive‐compulsive disorder (treatment may be incompatible with the study intervention)
chronic, serious tics or Tourette's Disorder (possible contraindication for stimulant treatment)
neuroleptic treatment in previous six months (may need resumption, which is incompatible with the study intervention)
major neurological or medical illness that would interfere with study participation or require medications incompatible with the medications used in the study (inability to participate in the study intervention)
history of intolerance to MTA medications (dangerous if participants assigned to arm involving medications)
suicidal or homicidal (needs more intensive treatment than the study intervention provides)
ongoing or previously undisclosed child abuse (risk of removal from home precludes parent intervention and consistent parent data)
missed more than 25% of school days in previous two months (interference with teacher assessments and school intervention)
another child in household already participating in the study intervention (cross‐arm contamination if two children in same household randomised to different arms)
same classroom as child already participating in the study intervention (cross‐arm contamination if two pupils in same classroom are randomised to different arms)
parental stimulant/cocaine abuse in past two years (possible co‐opting of child's medications)
inability of parent to speak English (inability to participate in parent training)
no telephone (inability to participate in telephone calls with therapists)
Baseline characteristics: no significant differences among study groups |
Interventions |
576 children allocated to one of four groups
Group one (n = 144): medication. In total, 14 months of medical intervention implemented as follows: one month of blind titration with methylphenidate for best dose, if unsatisfactory, then open titration with d‐amphetamine, pemoline, imipramine, and others. Supplementary general advice and selected readings without systematic behavioural intervention. Monthly visits after the titration period, doses adjusted as indicated by monthly monitors
Group two (n = 144): psychosocial. Intensive behavioural treatment consisting of three major components: 1) 27 group and eight individual sessions of parent training; 2) school intervention comprising teacher consultations (six to 20 sessions) and 12 weeks with classroom behavioural specialist for half the time in the classroom; and 3) a child treatment component anchored in an intensive 8‐week, full‐time, summer treatment programme. No medication
Group 3 (n = 145): combined treatment. Integration of all treatment components in medication + psychosocial treatment groups and standard community care
Group 4 (n =143): standard community care. Treatment of own choosing in the community; no treatment provided by the study group
Attendance: in group two and three, the families attended an average of 77.8% of the parent training sessions and 36.2 of 40 possible summer treatment programme days. In the school component, there was an average of 10.7 teacher consultation visits and 47.6 out of 60 possible days of work with a classroom aid |
Outcomes |
Primary outcomes
Social skills: SSRS, parent‐, child‐ and teacher‐rated
General behaviour: CBCL, parent‐ and teacher‐rated
Secondary outcomes
Core ADHD symptoms: Swanson, Nolan and Pelham Rating Scale, teacher‐ and parent‐rated
Performances and grades in school: Wechsler Individual Achievement Test (WIAT)
Outcome assessment: post‐intervention, end of treatment and follow‐up data |
Notes |
Study ID:NCT00000388 Sponsorship source: The study was supported by grants from the National Institute of Mental Health (UO1 MH50461, U01 MH50447, U01 MH5044, Uo1 MH50453, U=1 MH 50454 and U01 MH50467). Year conducted: not stated Duration of the study: 38 months Comments: The Multimodal Treatment Study (MTA study) is a cooperative study, performed by six independent research teams in collaboration with the National Institute of Mental Health, Rockville, MD, and the Office of Special Education Programs, US Department of Eduation, Washington, DC. Lead author: MTA Cooperative Group. Corresponding author: Peter S Jensen Institution: Department of Child Psychiatry, Unit 78, Center for the Advancement of Children's Mental Health, New York State Psychiatric Institute/Columbia University Email: jensenp@child.cpmc.columbia.edu Address: 1051 RiversideDr, New York, NY 10032 |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Comment: adequate method used |
Allocation concealment (selection bias) |
Low risk |
Comment: adequate method used |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Comment: no blinding |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Comment: blinded and unblinded raters |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Comment: used imputation |
Selective reporting (reporting bias) |
Unclear risk |
Comment: where is the consumer satisfaction and the CBCL data reported? We requested clarification from one of the study investigators, but had received no response when this review was finished. |
Vested interest bias |
Low risk |
Comment: no vested interest |
Other sources of bias? |
Low risk |
Comment: no other apparent sources of bias |