|
subjectkey |
GUID |
|
Required |
The NDAR Global Unique Identifier (GUID) for research subject |
NDAR*
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|
src_subject_id |
String |
20
|
Required |
Subject ID how it's defined in lab/project |
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|
patid, randid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
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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.
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sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
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;
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Query
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ptlnone |
Integer |
|
Recommended |
No Psych. Trt since last TADS visitNo Psychiatric Treatment since last TADS visit |
1
|
1 = Yes
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|
Query
|
ptl_sq |
Integer |
|
Recommended |
Psychiatric treatment: sequence number |
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|
Query
|
med_sq |
String |
40
|
Recommended |
Psychiatric medication: sequence number |
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|
med_nm |
String |
50
|
Recommended |
Psychiatric medication: name |
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|
|
Query
|
med_tp |
Integer |
|
Recommended |
Psychiatric medication: type |
1::6
|
1 = AD: Antidepressant; 2 = AA: Anxiolytic; 3 = AP: Antipsychotic; 4 = ST: Stimulan;t 5 = MS: Mood Stabilizer; 6 = OT: Other
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|
Query
|
bsit0 |
Float |
|
Recommended |
Weeks from Time 0/baseline to assessment |
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|
med_ont0 |
Query
|
mde_oft0 |
Float |
|
Recommended |
Event offset: Weeks-TADS Time 0 to asst. Weeks from TADS Time 0 to assessment |
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|
med_oft0 |
Query
|
bsimo |
Float |
|
Recommended |
Months from Time 0 to assessment |
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|
med_onmo |
Query
|
bsistm |
Float |
|
Recommended |
Months from SOFTAD enrollment date to assessment |
|
|
m_onstm |
Query
|
med_fin |
Integer |
|
Recommended |
Psychiatric medication: final status |
1;2
|
1 = Ongoing; 2 = Completed
|
|
Query
|
pth_sq |
String |
40
|
Recommended |
Psychotherapy: sequence number |
|
|
|
Query
|
pth_tp |
Integer |
|
Recommended |
Psychotherapy: type |
1::6
|
1 = CBT: Cognitive behavioral; 2 = IPT: Interpersonal; 3 = ST: Supportive; 4 = FT: Family; 5 = GT: Group; 6 = OT: Other
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|
Query
|
pth_ont0 |
Float |
|
Recommended |
Psychotherapy onset: Wks. TADS Time0 to asst.Psychiatric therapy onset: Weeks from TADS Time 0 to assessment |
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|
|
Query
|
pth_oft0 |
Float |
|
Recommended |
Psychotherapy offset: Wks. TADS Time0 to asst.Psychiatric therapy offset: Weeks from TADS Time 0 to assessment |
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|
|
Query
|
pth_onmo |
Float |
|
Recommended |
Psychotherapy onset: Mos. TADS Time0 to asst.Psychiatric therapy onset: Months from TADS Time 0 to assessment |
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|
|
Query
|
p_onstm |
Float |
|
Recommended |
Psychotherapy onset: Mos. SOFTAD enr. to asst.Psychiatric therapy onset: Months from SOFTAD enrollment date to assessment |
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|
|
Query
|
pth_fin |
Integer |
|
Recommended |
Psychotherapy: final status |
1;2
|
1 = Ongoing; 2 = Completed
|
|
Query
|
bima_1 |
Integer |
|
Recommended |
How has your mood been? Have you experienced a reasonable sense of cheerfulness or have you felt low spirited and depressed? Since your last appointment, how much of the time have you felt cheerful, contented or sad? How often would you say your moods change? Do they ever last all day? When was the last time you felt that way for a noticeable or extended period of time? |
1;2;3;4
|
1=Absent; 2=Mild; 3=Moderate; 4=Severe
|
|
|
bima_1a |
String |
255
|
Recommended |
How has your mood been? Explain |
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|
|
Query
|
bima_2 |
Integer |
|
Recommended |
Have you felt anxious or worried? If yes what do you experience? Is this something new? How long does it last? How many times since your last appointment? Does it ever last for more than half a day? If so, when was the last time you felt that anxious or worried? |
1;2;3;4
|
1=Absent; 2=Mild; 3=Moderate; 4=Severe
|
|
|
bima_2a |
String |
255
|
Recommended |
Have you felt anxious or worried? Explain |
|
|
|
Query
|
bima_3 |
Integer |
|
Recommended |
Have you had any changes in your program or housing? |
1;2
|
1=Yes; N=No
|
|
|
bima_3a |
String |
100
|
Recommended |
Have you had any changes in your program or housing? When? |
|
|
|
|
bima_3b |
String |
100
|
Recommended |
Have you had any changes in your program or housing? Where? |
|
|
|
|
bima_3c |
String |
255
|
Recommended |
Have you had any changes in your program or housing? Why? |
|
|
|
Query
|
bima_4 |
Integer |
|
Recommended |
Have you had to come to the ER here or at any other hospital? |
1;2
|
1=Yes; N=No
|
|
|
bima_4a |
String |
100
|
Recommended |
Have you had to come to the ER here or at any other hospital?When? |
|
|
|
|
bima_4b |
String |
100
|
Recommended |
Have you had to come to the ER here or at any other hospital? Where? |
|
|
|
|
bima_4c |
String |
255
|
Recommended |
Have you had to come to the ER here or at any other hospital? Why? |
|
|
|
Query
|
bima_5 |
Integer |
|
Recommended |
Have you had to be admitted to the hospital here or at any other hospital? |
1;2
|
1=Yes; N=No
|
|
|
bima_5a |
String |
100
|
Recommended |
Have you had to be admitted to the hospital here or at any other hospital? When? |
|
|
|
|
bima_5b |
String |
100
|
Recommended |
Have you had to be admitted to the hospital here or at any other hospital? Where? |
|
|
|
|
bima_5c |
String |
255
|
Recommended |
Have you had to be admitted to the hospital here or at any other hospital? Why? |
|
|
|
Query
|
bima_6 |
Integer |
|
Recommended |
How do you see the future for yourself? Are you optimistic or pessimistic about your future? Have you felt hopeful or hopeless about your future? If hopeless ask the following: Have you felt like giving up or, is there still a reason you should keep trying? |
1;2;3;4
|
1=Absent; 2=Mild; 3=Moderate; 4=Severe
|
|
|
bima_6a |
String |
255
|
Recommended |
How do you see the future for yourself? Explain |
|
|
|
Query
|
bima_7 |
Integer |
|
Recommended |
Since your last visit, have you felt that life wasnt worth the effort? Have you felt like you would be better off if you stopped living? Have you thought about harming yourself or ending it all? If yes, ask the following: What did you think of doing to yourself? Did you do anything that was harmful to yourself? Would you be able to stop yourself from doing something harmful if you felt like that again? |
1;2;3;4
|
1=Absent; 2=Mild; 3=Moderate; 4=Severe
|
|
|
bima_7a |
String |
255
|
Recommended |
Since your last visit, have you felt that life wasnt worth the effort? Explain |
|
|
|
Query
|
bima_8 |
Integer |
|
Recommended |
Have you felt like hurting someone else or damaging something? If yes - Have you acted on these feelings? If yes, ask the following: What did you do? Have you felt threatened by anyone or have you threatened anyone since your last visit? Have you been involved in any arguments or fights? |
1;2;3;4
|
1=Absent; 2=Mild; 3=Moderate; 4=Severe
|
|
|
bima_8a |
String |
255
|
Recommended |
Have you felt like hurting someone else or damaging something? Explain |
|
|
|
Query
|
item21 |
Integer |
|
Recommended |
Psychiatric hospitalization |
1;2
|
1=no;2=yes
|
bima_19 |
Query
|
bima_20 |
Integer |
|
Recommended |
Since the last appointment, did the patient experience: Psychiatric ER visit? |
1;2
|
1=No;2=Yes
|
|
Query
|
bima_21 |
Integer |
|
Recommended |
Since the last appointment, did the patient experience: Psychiatric Crisis intervention to avoid hospitalization? |
1;2
|
1=No;2=Yes
|
|
Query
|
bima_22 |
Integer |
|
Recommended |
Since the last appointment, did the patient experience: Deliberate self-injury? |
1;2
|
1=No;2=Yes
|
|
Query
|
bima_23 |
Integer |
|
Recommended |
Since the last appointment, did the patient experience: Clinically significant suicidal ideation? |
1;2
|
1=No;2=Yes
|
|
Query
|
bima_24 |
Integer |
|
Recommended |
Since the last appointment, did the patient experience: Clinically significant homicidal ideation? |
1;2
|
1=No;2=Yes
|
|
Query
|
bima_25 |
Integer |
|
Recommended |
Since the last appointment, did the patient experience: Violent behavior resulting in clinically significant injury to another person or property damage? |
1;2
|
1=No;2=Yes
|
|
Query
|
bima_26 |
Integer |
|
Recommended |
Current adherence to psychotropic medications- behavior (estimate) |
1;2;3;4;5
|
1 = Took medication all or almost all of the time; 2 = Took medication much of the time and/or at lower dose than prescribed; 3 = Took medication about half the time; 4 = Took medication sporadically or less than half the time; 5= Did not take medication at all
|
|
Query
|
bima_27 |
Integer |
|
Recommended |
Current adherence to psychotropic medications- assistance/support |
1;2;3;4
|
1=None � took medication independently; 2=Received urging, encouragement, or reminders; 3=Received supervision � e.g., medication is administered by someone else; 4=Does not apply � did not take medication
|
|
Query
|
bima_28 |
Integer |
|
Recommended |
Number of anti-psychotic medications prescribed. |
|
|
|
Query
|
bima_29 |
Integer |
|
Recommended |
Number of other psychotropic medications prescribed. |
|
|
|
Query
|
bima_30 |
Integer |
|
Recommended |
Number of other non-psychotropic medications prescribed. |
|
|
|
Query
|
bima_31 |
Integer |
|
Recommended |
Number of times per day patient must take medications |
|
|
|
Query
|
relevn |
Integer |
|
Recommended |
Event Number |
1::7
|
No event number= No Relapse or Exacerbation Event occurred
|
|
Query
|
relevty |
String |
2
|
Recommended |
Event Type |
E;R
|
E=Psychiatric Exacerbation; R=Psychiatric Relapse
|
|
|
relevnw |
String |
2
|
Recommended |
Event Number within Event Type |
|
S = single event period;
F = first of the event period; C = continuing event period; L = last of event period
|
|
Query
|
intrt |
Integer |
|
Recommended |
Treatment Status Code |
0::2
|
0=Baseline; 1=In Treatment; 2=In Follow-up
|
|
Query
|
trtgrp_p |
Integer |
|
Recommended |
Treatment Group |
1;2
|
1=Long-Acting Injectable Risperidone Microspheres; 2=Second Generation Oral Antipsychotic Medication
|
|
Query
|
days_visit1 |
Integer |
|
Recommended |
Days from Visit 1 |
|
|
dav1bima |
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
|
|
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
|
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
vtypbima |
Query
|
possvisit |
Integer |
|
Recommended |
Possible number of visits |
|
|
|