|
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 |
|
|
bid, case_id |
|
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.
|
bslage |
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
site_no |
Query
|
trt_grp |
String |
10
|
Recommended |
Treatment Group Assignment |
1;1AO;1CT;2; 3;4;5;6;7;8;9;10;11;12; O; P; CCA; GCT; TCT; TAU; CGC; ESDM; NA; EG
|
1=Group 1 first 8 weeks; 2=Group 2; 3=Group 3; 4 =active; 5=sham; 6=none; 7=ESDM High intensity; 8=ESDM Low intensity; 9=EIBI High intensity; 10=EIBI Low intensity; ESDM = Early Start Denver Model; EIBI = Early and Intensive Behavioral Intervention; 11 = Navigator; 12 = Care manager; 13=Waitlist Control; 14=Treatment; 1AO=Group 1 8 week add on; 1CT=Group 1 8 week cross taper; O=Oxytocin; P=Placebo; CCA=Community Control Arm; GCT=Generalized Cognitive Training; TCT=Targeted Cognitive Training; TAU=Treatment as Usual; CGC = Computer Games Control; NA=not assigned to treatment group; EG= Experimental Group
|
|
Query
|
days_baseline |
Integer |
|
Recommended |
Days since baseline |
|
|
bsldays |
Query
|
etype |
String |
10
|
Recommended |
Rating Period |
BSL;WK1;WK2;WK3;WK4;WK5;WK6;WK7;WK8;WK9;WK10;WK11;WK12;WK13;WK14;WK15;WK16
|
BSL=Baseline; WK1-WK16=Weeks 1-16
|
|
Query
|
respond_detail_oth_spec |
String |
255
|
Recommended |
Respondent details |
|
|
informnt |
Query
|
relationship |
Integer |
|
Recommended |
Relationship of respondent to individual |
|
1 = Biological mom; 2 = Biological dad; 3 = Grandparent; 4 = Special education (sped) teacher; 5 = General education teacher; 6 = Occupational therapist; 7 = Speech and language therapist; 8 = Behavioral therapist; 9 = Paraprofessional; 10 = Aide; 11 = Principal; 12 = Administrator; 14 = Content teacher; 15 = Parent center director; 16 = Self; 17=Adoptive mother; 18=Adoptive father; 19=Foster mother; 20 = Foster father; 21=Grandmother; 22=Grandfather; 23=Step-mother; 24 = Step-father; 25=Aunt; 26=Uncle; 28=Both parents;31= Grandmother from mother side; 32= Grandfather from mother side; 33= Grandmother from father side; 34= Grandfather from father side; 36= Brother; 37= Sister; 38= Cousin; 39= female caregiver; 40=male caregiver; 41=Female child; 42=Male child; 43=Spouse/Mate; 44=Friend; 45=Parent; 46=Significant other; 47=Sibling; 48=Son/Daughter; 49=Son-in-law/Daughter-in law; 50=Other Relative; 51=Paid caregiver; 52=Friends; 53=Roommate; 54=Supervisor; 55=mother's boyfriend; 56=other parental figure; 57=Summary; 58=counselor ; 59 = other female relative; 60 = other male relative; 61 = non-relative ; 62=Maternal Aunt; 63=Maternal Uncle; 64=Maternal Cousin; 65 = Paternal Aunt; 66=Paternal Uncle; 67=Paternal Cousin ; 68=Biological/Adoptive Mother and Grandmother; 69=Biological/Adoptive Mother and Stepmother and Grandmother; 70=Biological/Adoptive Mother and Grandmother and Foster Father; 71=Biological/Adoptive Mother and Stepmother and Foster Mother; 72=Biological/Adoptive Mother and Foster Mother; 73=Biological/Adoptive Mother and Biological/Adoptive Father; 74=Biological/Adoptive Mother and Stepmother and Biological/Adoptive Father; 75=Biological/Adoptive Mother and Other; 76=Biological/Adoptive Mother and Stepmother and Stepfather; 77=Biological/Adoptive Mother and Stepfather; 78=Biological/Adoptive Mother and Grandfather; 79=Biological/Adoptive Mother and Stepmother and Foster Father; 80=Biological/Adoptive Mother and Stepmother; 81=Guardian, female; 82=Other female; 83=Guardian, male; 84=Other male; 85=Other/Grandparent/Nanny; 86 = Mother, Father, Guardian; 87 = Daughter, son, grandchild; 88 = Professional (e.g., social worker, nurse, therapist, psychiatrist, or group home staff); -999=Missing; 89 = Biological parent; 90=Other; 91 = Stepparent; 92 = Adoptive parent; 93 = Foster parent; 94 = Co-worker
|
infrmnt2 |
Query
|
dfrsn |
Integer |
|
Recommended |
Reason for discontinuation |
1::7
|
1=Hospitalization; 2=Pregnancy; 3=Onset of severe illness; 4=Worsening of symptoms; 5=Use of more than 10 doses of Chlorpromazine; 6=Weight/BMI increase; 7=Other
|
|
Query
|
df_reason |
String |
10
|
Recommended |
Reason for discontinuation recorded |
HOSP;PREG;ILL;WORS;CHLR;WGT;CHNG;SIDE;GEOG;OTHR
|
HOSP=Hospitalization; PREG=Pregnancy; ILL=Onset of severe illness; WORS=Worsening of symptoms; CHLR=Use of more than 10 doses of Chlorpromazine; WGT=Weight/BMI increase; CHNG=Changed mind; GEOG=Geographical relocation; OTHR=Other
|
|
Query
|
df_commnt |
String |
250
|
Recommended |
If other-provide details |
|
|
|
Query
|
rtda1 |
Integer |
|
Recommended |
What date was the assigned study treatment stopped? |
0::999
|
|
rtda2_1 |
Query
|
rtda2 |
Integer |
|
Recommended |
Did patient successfully complete the protocol on the assigned treatment? |
0;1
|
1=Yes; 0=No
|
rtda1_1 |
Query
|
rtda3 |
Integer |
|
Recommended |
Was study treatment discontinued for administrative reasons? |
0;1
|
1=Yes; 0=No;Note: This implies that both the patient and the clinical staff judge the assigned antipsychotic treatment to be a success (i.e. adequately effective, with tolerable or no side effects), and that treatment would have continued if not for the administrative reason independent of the study procedures.
|
|
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
|
Query
|
fseqno |
Integer |
|
Recommended |
Sequence Number |
0::999
|
The FSEQNO variable in the ADJ form has a special interpretation compared to other forms.
For example, ADJ FSEQNO of '1' can be thought of as being '001', FSEQNO of '2' can be thought of as
being '002', and FSEQNO of '3' can be thought of as being '003'.
The first digit of FSEQNO relates to the corresponding ENF sequence number at that visit and the third
digit relates to the specific adjudicator who completed the adjudication form.
|
|
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
vers |
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
rtda0b |
Query
|
rtda1a |
Integer |
|
Recommended |
Did patient complete 24 weeks on the assigned anti-psychotic? (Y/N) |
0;1
|
0=No; 1=Yes
|
|
Query
|
rtda2a |
Integer |
|
Recommended |
What date was the study anti-psychotic stopped? [days since randomization] |
0::365
|
|
|
Query
|
rtda3a |
Integer |
|
Recommended |
What was the reason the study anti-psychotic was stopped? (choose the primary reason) A. Efficacy/Inadequate therapeutic effect: Positive symptoms, negative symptoms, mood symptoms, other. B. Unacceptable side effects: Weight, lipids, glucose, EPS, TD, akathisia/activation, sedation, insomnia, agitation, sexual side effects, nausea, other. C. Patient refusal : Does not see need for or benefit from antipsychotic, no longer wants to participate in study. D. Patient dropped out, no information available E. Death/Illness F. Administrative |
1;3;4;6;10;12;13;16;17;18;19;21;999
|
01=Positive Symptoms; 03=Mood Symptoms; 04=Other efficacy/inadequate therapeutic effect (specify); 06=Lipids; 10=Akathisia/activation; 12=Insomnia; 13=Agitation; 16=Other unacceptable side effects (specify); 17=Does not see need for or benefit from antipsychotic treatment; 18=No longer wants to participate in study (but will still take meds); 19=Patient dropped out, no information available; 21=Administrative (specify); 999= Legitimately skipped
|
|
Query
|
rtda3_1 |
Integer |
|
Recommended |
What was the primary reason the study treatment was stopped? |
01::19; 999
|
01=Weight; 02=Diarrhea; 03=Nausea; 04=Vomiting; 05=Abdominal Discomfort; 06=Headache; 07=Weakness; 08=Muscle Pain; 09=Alcohol Use; 10=Lipids; 11=Glucose; 12=GGT; 13=Other; 14=Patient Refusal:Does not see need for or benefit from study medication; 15=Patient Refusal: Unacceptable side effects; 16=Patient Refusal: No longer wants to participate in study; 17=Patient dropped out, no information available; 18=Death/Illness; 19=Administrative; 999=Legitimately skipped
|
|
|
tx_pd_oth_spec |
String |
30
|
Recommended |
Reason for discontinuation: Specify 'other' reason |
|
|
|
|
tx_lt8_complete |
Integer |
|
Recommended |
Did the participant complete less than 8 treatment sessions |
1;2
|
1 = Yes; 2 = No
|
|
|
final_tx_date |
Date |
|
Recommended |
Date of final treatment |
|
|
|
|
final_tx_num |
Integer |
|
Recommended |
Final treatment number |
1::21
|
|
|
|
tx_prm_discon |
Integer |
|
Recommended |
Was treatment prematurely discontinued |
1;2
|
1 = Yes; 2 = No
|
|
|
tx_pd_wrse_dprs |
Integer |
|
Recommended |
Reason for discontinuation: worsening depression |
1;2
|
1 = Yes; 2 = No
|
|
|
tx_pd_inc_si |
Integer |
|
Recommended |
Reason for discontinuation: increase in suicidal ideation |
1;2
|
1 = Yes; 2 = No
|
|
|
tx_pd_manic |
Integer |
|
Recommended |
Reason for discontinuation: clinically significant hypomanic or manic symptoms |
1;2
|
1 = Yes; 2 = No
|
|
|
tx_pd_consent |
Integer |
|
Recommended |
Reason for discontinuation: withdrew consent |
1;2
|
1 = Yes; 2 = No
|
|
|
tx_pd_miss_seiz |
Integer |
|
Recommended |
Reason for discontinuation: Missed seizures on 2 consecutive treatment sessions |
1;2
|
1 = Yes; 2 = No
|
|
|
tx_pd_noncomp |
Integer |
|
Recommended |
Reason for discontinuation: Non-compliance with treatment schedule |
1;2
|
1 = Yes; 2 = No
|
|
|
tx_pd_oth |
Integer |
|
Recommended |
Reason for discontinuation: Other reason |
1;2
|
1 = Yes; 2 = No
|
|