PMID- 28715242
OWN - NLM
STAT- MEDLINE
DCOM- 20200527
LR  - 20220429
IS  - 1537-4424 (Electronic)
IS  - 1537-4416 (Print)
IS  - 1537-4416 (Linking)
VI  - 48
IP  - sup1
DP  - 2019
TI  - Not All Masks Are Created Equal: Masking Success in Clinical Trials of Children 
      and Adolescents.
PG  - S227-S233
LID - 10.1080/15374416.2017.1342547 [doi]
AB  - The current study assessed the success of masking omega-3 (Omega3) and psychotherapy 
      in clinical trials of youth with depression or bipolar spectrum disorder. 
      Participants were youth ages 7-14 with DSM-IV-TR diagnosed depressive (n = 72) or 
      bipolar spectrum (n = 23) disorders. Inclusion diagnoses were depressive 
      disorder, cyclothymic disorder, or bipolar disorder not otherwise specified. 
      Exclusion diagnoses included bipolar I or II disorder, chronic medical condition 
      or autism. Youth participated in 2 x 2 randomized controlled trials, in which 
      they received Omega3 or placebo (PBO) and psychoeducational psychotherapy (PEP) or 
      active monitoring (AM). Participants and study staff (including independent 
      interviewers) were masked to Omega3/PBO allocation. Besides the masked independent 
      interviewers, one coprincipal investigator (Co-PI) was fully masked to both 
      conditions and completed all consensus conference ratings postrandomization. At 
      the endpoint assessment or last completed interview, interviewers and the masked 
      Co-PI guessed whether each child was assigned to Omega3 or PBO and to PEP or AM. 
      Masking failure was calculated using the degree of correct guesses above chance 
      level using binomial tests across all participants for Omega3 versus PBO and PEP 
      versus AM. For all guessers, Omega3 allocation was guessed correctly approximately 
      half the time (50%-52.5%). Rates of correct guessing were higher for PEP, but 
      only the interviewer guesses were correct significantly more often (58.5%-68.7%) 
      than chance. Reporting of masking success should be an essential element of RCTs. 
      Psychotherapy is generally more difficult to mask, but with attentive masking 
      procedures reasonable masking can be achieved.
FAU - Jones, Lauren
AU  - Jones L
AD  - a Department of Psychology , The University of Notre Dame.
FAU - Black, Sarah R
AU  - Black SR
AUID- ORCID: 0000-0002-8090-1217
AD  - b Department of Psychiatry and Behavioral Health , The Ohio State University 
      Wexner Medical Center.
FAU - Arnold, L Eugene
AU  - Arnold LE
AD  - b Department of Psychiatry and Behavioral Health , The Ohio State University 
      Wexner Medical Center.
FAU - Fristad, Mary A
AU  - Fristad MA
AD  - b Department of Psychiatry and Behavioral Health , The Ohio State University 
      Wexner Medical Center.
LA  - eng
GR  - R34 MH085875/MH/NIMH NIH HHS/United States
GR  - R34 MH090148/MH/NIMH NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170717
PL  - England
TA  - J Clin Child Adolesc Psychol
JT  - Journal of clinical child and adolescent psychology : the official journal for 
      the Society of Clinical Child and Adolescent Psychology, American Psychological 
      Association, Division 53
JID - 101133858
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Diagnostic and Statistical Manual of Mental Disorders
MH  - Female
MH  - Humans
MH  - Male
MH  - Psychotherapy/*methods
PMC - PMC9003566
MID - NIHMS1505364
EDAT- 2017/07/18 06:00
MHDA- 2020/05/28 06:00
PMCR- 2022/04/12
CRDT- 2017/07/18 06:00
PHST- 2017/07/18 06:00 [pubmed]
PHST- 2020/05/28 06:00 [medline]
PHST- 2017/07/18 06:00 [entrez]
PHST- 2022/04/12 00:00 [pmc-release]
AID - 10.1080/15374416.2017.1342547 [doi]
PST - ppublish
SO  - J Clin Child Adolesc Psychol. 2019;48(sup1):S227-S233. doi: 
      10.1080/15374416.2017.1342547. Epub 2017 Jul 17.