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subjectkey |
GUID |
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Required |
The NDAR Global Unique Identifier (GUID) for research subject |
NDAR*
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src_subject_id |
String |
20
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Required |
Subject ID how it's defined in lab/project |
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interview_date |
Date |
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Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
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interview_age |
Integer |
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Required |
Age in months at the time of the interview/test/sampling/imaging. |
0 :: 1260
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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
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Required |
Sex of subject at birth |
M;F; O; NR
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M = Male; F = Female; O=Other; NR = Not reported
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Query
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site |
String |
101
|
Recommended |
Site |
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Study Site
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study |
String |
100
|
Recommended |
Study; The code for each individual study |
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Query
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daysrz |
Integer |
|
Recommended |
days since randomization |
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Query
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visit |
String |
60
|
Recommended |
Visit name |
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Query
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completed |
Integer |
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Recommended |
Checks if completed |
0::3
|
0=No; 1=Yes; 2=Yes, lost; 3=Unverified
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Query
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ci_enrolled |
Integer |
|
Recommended |
Participant enrolled |
0;1
|
0=No; 1=Yes
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Query
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relationship |
Integer |
|
Recommended |
Relationship of respondent to individual |
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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
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Query
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bkgrnd_education |
String |
1,020
|
Recommended |
Subject's education (school and preschool) |
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Query
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afterstdy_q05 |
Integer |
|
Recommended |
Main goal of doctors |
1::5;9
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1 = To find out if a certain medication helps children with autism; 2 = To give free care to children with autism; 3 = To give a medication that is available only in research studies.; 4 = To see if Parent Management Training will produce gains over and above those seen with [medication]; 5 = To find out if medication only helps children with autism
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Query
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stpnm1 |
String |
250
|
Recommended |
Study med name1 |
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Query
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afterstdy_q07 |
Integer |
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Recommended |
Informed before child received med. |
1::4;9
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1 = I was informed by the study doctor(s) and/or other staff of what this study is about and my questions were adequately answered; 2 = There was no information available on the study; 3 = The study doctor(s) or other staff didn't inform me, but I found information elsewhere; 4 = I was told that the purpose needed to be a secret for the study to "work right
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Query
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afterstdy_q08 |
Integer |
|
Recommended |
Permission before child received med. |
1::4;9
|
1 = Nobody asked me permission to start the study; 2 = I gave only verbal permission to the study staff to enter him/her into the study; 3 = I gave written permission to the study staff to enter him/her into the study; 4 =The study staff members said that permission was assumed, because I would not have to come ...
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Query
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afterstdy_q09 |
Integer |
|
Recommended |
In this study... |
1::4;9
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1 = Some children were given "real" medication and other children "inactive" medication (also called placebo) for 2 months; 2 = All children were given "real" medication for 2 months; 3 = All children were given "inactive" medication for 2 months before they could receive "real medication" ; 4 = no medication is involved
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Query
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afterstdy_q10 |
Integer |
|
Recommended |
...the chance of being assigned placebo |
1::4;9
|
1 = 0%; 2 = 50%; 3 = 75%; 4 = 100%
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Query
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afterstdy_q11 |
Integer |
|
Recommended |
When the study started... |
1::4;9
|
1 = Some children were given "real" medication and other children "inactive" medication (also called placebo) for 2 months; 2 = All children were given "real" medication for 2 months; 3 = All children were given "inactive" medication for 2 months before they could receive "real medication" ; 4 = no medication is involved
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Query
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afterstdy_q12 |
Integer |
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Recommended |
Before start, risks/benefits... |
1::4;9
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1 = I understood that there were only advantages and benefits, but no risks at all, in participation in the study; 2 = I understood that there were both possible advantages (benefits) and risks, and the doctors told me which the main risks were.; 3 = I was not informed of any benefits or risks possibly associated with this study; 4 = I was told that there were no possible benefits for my child
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Query
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afterstdy_q13 |
Integer |
|
Recommended |
Side effects |
1::5;9
|
1 = Dizziness, abnormal movements of the head or neck, weight gain; 2 = Hair loss, anemia, weight loss; 3 = Diarrhea, vomiting, and heart problems; 4 = Ringing in the ears and coldness in the extremitites (hands and feet); 5 = Craving for salt, reduced appetite, and sweating
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Query
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afterstdy_q14 |
Integer |
|
Recommended |
At the time I agreed, study med |
1::4;9
|
1 = I was informed of the possible alternatives for treatment; 2 = I understood that there were no alternatives besides the study; 3 = The study medicine was not available yet outside the study; 4 = Parent Management Training has already been proven effective to cure autism
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Query
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afterstdy_q15 |
Integer |
|
Recommended |
After consent, drop out was... |
1::4;9
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1 = It was not possible for my child to drop out of the study before it was completed, even if I wanted him to stop; 2 = I could have taken my child off the study at any time, if I wanted, even if the study was yet not finished; 3 = My child could have stopped the study but only with the permission of the study doctors; 4 = Leaving the study would have resulted in loss of all services at this Medical Center
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Query
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afterstdy_q16 |
Integer |
|
Recommended |
If dropout, treatment would... |
1::9
|
1 = My child would have to wait for medical care until the study is completed; 2 = My child could not have been treated with the type of medication that is given in this study; 3 = My child would have continued treatment with another doctor; 4 = My child would have to wait for Parent Management Training until the study is completed; 5 = My child could not receive the treatments that are given in this study; 6 = My child could have received these treatments with other therapists in the community; 7 = Parent Management Training would be made available free
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Query
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afterstdy_q17 |
Integer |
|
Recommended |
Study treatment assignment |
1::5;9
|
1 = Randomly (that is by the tossing of a coin); 2 = By the child; 3 = Based on the individual needs of each child to ensure that each child received the best possible treatment for his/her condition; 4 = Based on the child's age; 5 = Based on the Treatment Preference Form that I completed at the beginning
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relation_specify |
String |
20
|
Recommended |
Relation Other Specify |
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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
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Query
|
ques6 |
Integer |
|
Recommended |
When I agreed to my child's participation in this study, the chance of his/her being assigned to receive only medication (no Parent Management Training) for the 6-month duration of the study was: |
1::4;9
|
1 = 0%; 2 = 33%; 3 = 50%; 4 = 100%
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Query
|
ques10 |
Integer |
|
Recommended |
A possible risk or disadvantage of the Parent Management Training is: |
1::4;9
|
1 = that it would result in punishment to my child; 2 = that it would require a lot of time and effort; 3 = that it would involve spoiling my child with bribes; 4 = I would have to spend a lot of money to make it work
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Query
|
ques15 |
Integer |
|
Recommended |
Before I stated in this study, I knew that, If I were assisgned to the medication + therapy group: |
1::4;9
|
1 = his/her teacher would have to give rating every two weeks for my child to stay in the study; 2 = I would have homework to do most weeks; 3 = The behavior therapist would visit out home whenever we needed him/her; 4 = Even if the medicine does not help, my child would have to continue it
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