|
subjectkey |
GUID |
|
Required |
The NDAR Global Unique Identifier (GUID) for research subject |
NDAR*
|
|
|
|
src_subject_id |
String |
20
|
Required |
Subject ID how it's defined in lab/project |
|
|
patid, randid, subjid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
|
|
interview_age |
Integer |
|
Required |
Age in months at the time of the interview/test/sampling/imaging. |
0::1440
|
Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
|
|
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
|
Query
|
stage |
Integer |
|
Recommended |
Study stage |
|
0 = Pre-Randomization (TADS) 1 = Stage 1 (TADS) 2 = Stage 2 (TADS) 3 = Stage 3 (TADS) 4 = Stage 4 (TADS) 5 = Stage 5 (SOFTAD); 51=Treatmentas Usual; 52=Screening Alone; 53=Intervention; 67=Unknown; -888=Not Applicable; -999=Missing;
|
|
Query
|
pmtgrp |
String |
10
|
Recommended |
Premature Termination Category |
no;s1;s1s;s2;s3
|
no = no PMT; s1 = Stage 1 PMT; s1s = Stage 1 Switcher; s2 = Stage 2 PMT; s3 = Stage 3 PMT
|
|
Query
|
drpgrp |
String |
10
|
Recommended |
Study Drop Category |
no;s1;s2;s3
|
no = no Drop; s1 = Stage 1 Drop; s2 = Stage 2 Drop; s3 = Stage 3 Drop
|
|
Query
|
tads_flx |
Integer |
|
Recommended |
Indicator of whether patient received a non-ASAP PT session during the stage (only counting sessions where it was clear the patient had been on drug on the session date).Note: This assumes that all PBO patients received FLX after Stage I PMT if PT sessions continued. |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
tads_cbt |
Integer |
|
Recommended |
Indicator of whether patient received a non-ASAP CBT session during the stage. |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
ntc_tt1 |
Integer |
|
Recommended |
First non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. |
1::8
|
1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
|
|
Query
|
ntc_tt2 |
Integer |
|
Recommended |
Second non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. |
1::8
|
1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
|
|
Query
|
ntc_tt3 |
Integer |
|
Recommended |
Third non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. |
1::8
|
1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
|
|
Query
|
ntc_tt4 |
Integer |
|
Recommended |
Fourth non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. |
1::8
|
1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
|
|
Query
|
ntc_tt5 |
Integer |
|
Recommended |
Fifth non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. |
1::8
|
1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
|
|
Query
|
ntc_tt6 |
Integer |
|
Recommended |
Sixth non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. |
1::8
|
1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
|
|
Query
|
ntc_tt7 |
Integer |
|
Recommended |
Seventh non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. |
1::8
|
1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
|
|
Query
|
ntc_tt8 |
Integer |
|
Recommended |
Eighth non-TADS treatment type (based on alphabetical text listing of treatment received) prescribed in the stage. |
1::8
|
1 = Anti-depressant; 2 = Stimulant; 3 = Anti-anxiety; 4 = Neuroleptic; 5 = Mood stabilizer; 6 = Other medication; 7 = CBT; 8 = Other psychosocial
|
|
Query
|
ntc_adep |
Integer |
|
Recommended |
Indicator of whether any prescribed treatment in the stage was anti-depressant medication. |
1
|
1 = Yes
|
|
Query
|
ntc_stim |
Integer |
|
Recommended |
Indicator of whether any prescribed treatment in the stage was stimulant medication. |
1
|
1 = Yes
|
|
Query
|
ntc_aanx |
Integer |
|
Recommended |
Indicator of whether any prescribed treatment in the stage was anti-anxiety medication. |
1
|
1 = Yes
|
|
Query
|
ntc_neur |
Integer |
|
Recommended |
Indicator of whether any prescribed treatment in the stage was neuroleptic medication. |
1
|
1 = Yes
|
|
Query
|
ntc_mood |
Integer |
|
Recommended |
Indicator of whether any prescribed treatment in the stage was mood stabilizing medication. |
1
|
1 = Yes
|
|
Query
|
ntc_othm |
Integer |
|
Recommended |
Indicator of whether any prescribed treatment in the stage was a medication other than those already classified. |
1
|
1 = Yes
|
|
Query
|
ntc_cbt |
Integer |
|
Recommended |
Indicator of whether any prescribed treatment in the stage was cognitive behavioral therapy. |
1
|
1 = Yes
|
|
Query
|
ntc_othp |
Integer |
|
Recommended |
Indicator of whether any prescribed treatment in the stage was an other psychosocial therapy. |
1
|
1 = Yes
|
|
Query
|
c_iph |
Integer |
|
Recommended |
Indicator of whether patient used an inpatient unit in a psychiatric hospital during the stage. |
1
|
1 = Yes
|
|
Query
|
c_igh |
Integer |
|
Recommended |
Indicator of whether patient used an inpatient psychiatric unit in a general hospital during the stage. |
1
|
1 = Yes
|
|
Query
|
c_idrg |
Integer |
|
Recommended |
Indicator of whether patient used an inpatient alcohol or drug treatment or detox unit during the stage. |
1
|
1 = Yes
|
|
Query
|
c_iemo |
Integer |
|
Recommended |
Indicator of whether patient used a regular medical inpatient unit for emotional, behavior, or substance use problems during the stage. |
1
|
1 = Yes
|
|
Query
|
c_rest |
Integer |
|
Recommended |
Indicator of whether patient used a residential treatment center during the stage. |
1
|
1 = Yes
|
|
Query
|
c_grph |
Integer |
|
Recommended |
Indicator of whether patient used a group home during the stage. |
1
|
1 = Yes
|
|
Query
|
c_day |
Integer |
|
Recommended |
Indicator of whether patient used a day hospital/day treatment during the stage. |
1
|
1 = Yes
|
|
Query
|
c_fost |
Integer |
|
Recommended |
Indicator of whether patient used therapeutic foster care during the stage. |
1
|
1 = Yes
|
|
Query
|
c_odrg |
Integer |
|
Recommended |
Indicator of whether patient used an outpatient drug or alcohol unit during the stage. |
1
|
1 = Yes
|
|
Query
|
c_cman |
Integer |
|
Recommended |
Indicator of whether patient used case management coordination during the stage. |
1
|
1 = Yes
|
|
Query
|
c_home |
Integer |
|
Recommended |
Indicator of whether patient used in-home counseling or crisis services during the stage. |
1
|
1 = Yes
|
|
Query
|
c_pro |
Integer |
|
Recommended |
Indicator of whether patient used professional treatment during the stage. |
1
|
1 = Yes
|
|
Query
|
c_doc |
Integer |
|
Recommended |
Indicator of whether patient used a medical doctor during the stage. |
1
|
1 = Yes
|
|
Query
|
c_er |
Integer |
|
Recommended |
Indicator of whether patient used an emergency room during the stage. |
1
|
1 = Yes
|
|
Query
|
c_hot |
Integer |
|
Recommended |
Indicator of whether patient used a crisis hotline during the stage. |
1
|
1 = Yes
|
|
Query
|
c_oth |
Integer |
|
Recommended |
Indicator of whether patient used other services during the stage. |
1
|
1 = Yes
|
|
Query
|
ssrimed |
Integer |
|
Recommended |
Non-TADS SSRI use |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
visitdt |
Query
|
study |
String |
100
|
Recommended |
Study; The code for each individual study |
|
|
studyid |
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
siteid |
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
int1, timept |
Query
|
completed |
Integer |
|
Recommended |
Checks if completed |
0::3
|
0=No; 1=Yes; 2=Yes, lost; 3=Unverified
|
formcomp |
Query
|
subtrial_name |
Integer |
|
Recommended |
Name of subtrial |
1::3
|
1=Crossover; 2=Guanfacine; 3= Open Label MPH
|
|
Query
|
pmtot |
Integer |
|
Recommended |
Total pages |
|
|
cttot |
Query
|
ctany |
Integer |
|
Recommended |
Treatments other than meds |
0;1
|
0=No; 1=Yes
|
|
Query
|
pmmednum |
Integer |
|
Recommended |
Medication/treatment number |
|
|
fi_dcode, trtnum |
|
treatment_name |
String |
200
|
Recommended |
treatment name |
|
|
ctname, fi_dname, fi_nname, treatment |
Query
|
cttae |
Integer |
|
Recommended |
Treatment for an AE |
0;1
|
0=No; 1=Yes
|
|
Query
|
aef001 |
Integer |
|
Recommended |
Adverse Event number |
|
-9=unknown
|
ctaenum |
Query
|
pmstdt |
Integer |
|
Recommended |
Date medication/treatment began in days from the randomization date |
|
|
ctstdt, daystart_t |
Query
|
cmcont |
Integer |
|
Recommended |
Continuing at end of study? |
1;2
|
1=Yes; 2=No
|
ctcont |
Query
|
pmstop |
Integer |
|
Recommended |
Date medication/treatment stopped in days from the randomization date |
|
|
ctstop, dayend_t |
Query
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
dayctl_t, vdaconm |
Query
|
slot_t |
Integer |
|
Recommended |
Slot on Concomitant Treatment Log form |
|
|
fi_drln, fi_ndrln |
Query
|
page_t |
Integer |
|
Recommended |
Page of Concomitant Treatment Log form |
|
|
|
Query
|
mh |
Integer |
|
Recommended |
Is Concomitant Treatment a mental health treatment? |
0;1
|
0 = No;1 = Yes
|
|
|
indication |
String |
50
|
Recommended |
Indication for which Concomitant Treatment used |
|
|
fi_dindi, fi_nindi |
Query
|
cont_t |
Integer |
|
Recommended |
Is Concomitant Treatment still being used? |
0;1
|
0 = No;1 = Yes
|
fi_dongo, fi_nongo |
Query
|
study_id |
Integer |
|
Recommended |
Study ID number |
|
46=Acute Phase; 47=Stabilization Phase
|
|
|
procedure |
String |
200
|
Recommended |
Concomitant Procedures |
|
|
|
Query
|
startdy |
Integer |
|
Recommended |
Start Day |
|
|
cdtstda, ndotstda, startdays |
Query
|
endday |
Integer |
|
Recommended |
Stop Day |
|
|
cdtspda, ndotspda, stopdays |
Query
|
fi_ckdrg |
Integer |
|
Recommended |
No concomitant medications |
0;1
|
0 = No;1 = Yes
|
|
Query
|
fi_ckndr |
Integer |
|
Recommended |
No concomitant non-drug treatment |
0;1
|
0 = No;1 = Yes
|
|
Query
|
saps_ad10 |
Integer |
|
Recommended |
Rater number |
|
|
|
|
fi_freq |
String |
35
|
Recommended |
Concomitant treatment frequency |
|
|
fi_nsess |
|
q14_unit |
String |
10
|
Recommended |
Dose: Unit |
|
In mg, tsp, pills, etc.
|
fi_unit |
Query
|
q14_qty |
Float |
|
Recommended |
Dose: Quantity |
0.0 :: 325; -7; -8; -9;999
|
-7 = Don't know; -8 = Refused to answer; -9 = Does not apply; 999 = Missing value
|
fi_dose |
|
route1 |
String |
50
|
Recommended |
route 1 |
|
|
|
Query
|
conmedno |
Integer |
|
Recommended |
Check if NO concomitant medications were used |
0;1
|
0=No; 1=Yes
|
|
Query
|
cntr_othrtrt |
Integer |
|
Recommended |
Received any treatments other than medic |
1;2
|
1=Yes;2=No
|
|
Query
|
visnum |
Float |
|
Recommended |
Numeric Visit Number |
|
-1.5 = Pre-Screening; -1 = Screening; 0 = Baseline; ## = Visit ## (from 1 to 10); Whole numbers = standard monthly visits; #.001 - #.009 = Unscheduled; #.1 = End of Phase 1; #.2 = End of Phase 2; #.3 = End of Phase 3; #.4 = End of Open Choice Phase; #.5 = End of Study; #.6 = Genetic Analysis; 1000=all visits
|
|
Query
|
anytrtmnt |
Integer |
|
Recommended |
Has the subject received medical treatment other than drugs 30 days prior to or during this study? |
0;1
|
0 = No; 1 = Yes
|
|
|
cmind |
String |
200
|
Recommended |
Indication |
|
|
|
|
cmstrtdt |
Date |
|
Recommended |
Start Date |
|
|
|
|
cmstpdt |
Date |
|
Recommended |
Stop Date |
|
|
|
|
contamination01 |
Integer |
|
Recommended |
Have you received any sleep intervention, treatment or coaching since entering the study? |
0; 1; -9
|
0 = No; 1 = Yes; -9 = Missing
|
|
|
contamination02b |
String |
100
|
Recommended |
Have you received any sleep intervention, treatment or coaching since entering the study? - If yes, with who or which group have you been working on sleep? |
|
|
|
|
contamination02a |
String |
100
|
Recommended |
Have you received any sleep intervention, treatment or coaching since entering the study? - If yes, what sleep work have you been doing? |
|
|
|
|
timepoint_label |
String |
50
|
Recommended |
Timepoint/visit label |
|
|
timepoint |
|
transcuse_01 |
Integer |
|
Recommended |
Are you still using Transdiagnostic Sleep and Circadian Intervention (TranS-C)? |
0; 1; -9
|
0 = No; 1 = Yes; -9 = Missing
|
|
|
transcuse_02 |
String |
1,000
|
Recommended |
If yes, what parts of Transdiagnostic Sleep and Circadian Intervention (TranS-C) are you still using? |
|
|
|