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After Study Knowledge Questionnaire

216 Shared Subjects

N/A
Clinical Assessments
Questionnaire
09/15/2015
askq01
03/20/2017
View Change History
01
Definition
Submission Template
Query Element Name Data Type Size Required Description Value Range Notes Aliases
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
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 :: 1260 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 site String 101 Recommended Site Study Site
study String 100 Recommended Study; The code for each individual study
Query daysrz Integer Recommended days since randomization
Query visit String 60 Recommended Visit name
Query completed Integer Recommended Checks if completed 0::3 0=No; 1=Yes; 2=Yes, lost; 3=Unverified
Query ci_enrolled Integer Recommended Participant enrolled 0;1 0=No; 1=Yes
Query relationship Integer Recommended Relationship of respondent to individual
1::94;-999
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
Query bkgrnd_education String 1,020 Recommended Subject's education (school and preschool)
Query afterstdy_q05 Integer Recommended Main goal of doctors 1::5;9 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
Query stpnm1 String 250 Recommended Study med name1
Query afterstdy_q07 Integer Recommended Informed before child received med. 1::4;9 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
Query 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 ...
Query afterstdy_q09 Integer Recommended In this study... 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
Query afterstdy_q10 Integer Recommended ...the chance of being assigned placebo 1::4;9 1 = 0%; 2 = 50%; 3 = 75%; 4 = 100%
Query 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
Query afterstdy_q12 Integer Recommended Before start, risks/benefits... 1::4;9 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
Query 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
Query 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
Query afterstdy_q15 Integer Recommended After consent, drop out was... 1::4;9 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
Query 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
Query 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
relation_specify String 20 Recommended Relation Other Specify
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 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%
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
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
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
  • For valid elements with shared data, on the far left is a Filter button you can use to view a summary of shared data for that element and apply a query filter to your Cart based on selected value ranges

At the top of this page you can also:

  • Use the search bar to filter the elements displayed. This will not filter on the Size of Required columns
  • Download a copy of this definition in CSV format
  • Download a blank CSV submission template prepopulated with the correct structure header rows ready to fill with subject records and upload

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