Emergency/Adjunct services and attrition prevention for randomized clinical trials in children: the MTA manual-based solution.
Treatment studies in child and adolescent psychiatry are increasingly characterized by long-term, multisite, randomized clinical trials (RCTs). During the course of these RCTs it is common for clinical exigencies to emerge that require rapid, direct intervention. The challenge is to provide clinically appropriate responses that do not contaminate the delivery, distinctness, and interpretation of the treatments under investigation. In multisite studies, the problem is compounded by the need to minimize cross-site differences in the delivery of adjunct treatments. Such minimization requires fully operationalized and manual-based procedures for clinically mandated intervention. The NIMH Collaborative Multisite Multimodal Treatment Study of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)--"the MTA"--is a long-term multisite collaborative study in which children with ADHD were randomly assigned to either medication management, behavioral treatment, the combination, or community-comparison assessment and referral. In designing its study, the MTA developed a manual-based set of procedures (the MTA Adjunct Services and Attrition Prevention [ASAP] Manual) for situations not covered by the protocol treatments. The majority of cases requiring adjunct services fell into two major categories: (1) crisis/emergent situations and (2) imminent risk of attrition. This report describes the ASAP guidelines for dealing with cases that required adjunct services that the MTA Steering Committee adopted before initiating the trial. Although the manual-based guidelines are especially applicable to multisite RCTs, many of the procedures in the ASAP Manual can apply to any treatment study in children.
Abikoff
Howard
H
Child and Adolescent Psychiatry, NYU Child Study Center, NYU School of Medicine, NY 10016, USA. abikoh01@med.nyu.edu
Arnold
L Eugene
LE
Newcorn
Jeffrey H
JH
Elliott
Glen R
GR
Hechtman
Lily
L
Severe
Joanne B
JB
Wigal
Timothy
T
Shapiro
Cheri
C
Cantwell
Dennis P
DP
Conners
C Keith
CK
Greenhill
Laurence L
LL
Hinshaw
Stephen P
SP
Hoza
Betsy
B
Jensen
Peter S
PS
Kraemer
Helena C
HC
March
John S
JS
Pelham
William E
WE
Swanson
James M
JM
Vitiello
Benedetto
B
Wells
Karen C
KC
D001289:Attention Deficit Disorder with Hyperactivity / Q000628:therapy*; D001521:Behavior Therapy; D015982:Bias; D000697:Central Nervous System Stimulants / Q000627:therapeutic use; D002648:Child; D003131:Combined Modality Therapy; D004637:Emergency Services, Psychiatric; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data*; D010043:Outcome and Process Assessment, Health Care; D010352:Patient Dropouts / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012017:Referral and Consultation
D000697:Central Nervous System Stimulants