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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL NBB

Study Screening Log

439 Shared Subjects

N/A
Clinical Assessments
Entry Form
01/05/2015
ssl01
03/22/2023
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 patid
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 gender
Query stage Integer Recommended Study stage
0::5; 51::53; 67; -888; -999
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 gateat0 Float Recommended Weeks from Time 0 (randomization) to Gate A Screening Form date
Query gateb1t0 Float Recommended Weeks from Time 0 (randomization) to Gate B1 Procedures date
Query gateb2t0 Float Recommended Weeks from Time 0 (randomization) to Gate B2 Procedures date
Query gatec1t0 Float Recommended Weeks from Time 0 (randomization) to Gate C1 Procedures date
Query gatec2t0 Float Recommended Weeks from Time 0 (randomization) to Gate C2 Orientation visit date
Query frsttxt0 Float Recommended Weeks from Time 0 (randomization) to First Treatment visit date
Query timeab1 Integer Recommended Time between Gate A and B1 (days)
Query timeb1c1 Integer Recommended Time between Gate B1 and C1 (days)
Query timec1c2 Integer Recommended Time between Gate C1 and C2 (days)
Query source1 Integer Recommended Source of recruitment: Advertisement for the TADS trial 1 1 = Yes
Query source2 Integer Recommended Source of recruitment: General advertisement for depression studies 1 1 = Yes
Query source3 Integer Recommended Source of recruitment: Internal referral 1 1 = Yes
Query source4 Integer Recommended Source of recruitment: External mental health professional referral 1 1 = Yes
Query source5 Integer Recommended Source of recruitment: External medical, but non- mental health, professional referral 1 1 = Yes
Query source6 Integer Recommended Source of recruitment: External non-medical professional referral 1 1 = Yes
Query source7 Integer Recommended Source of recruitment: Personal referral 1 1 = Yes
Query source8 Integer Recommended Source of recruitment: NIMH Web site / other Internet source 1 1 = Yes
Query source9 Integer Recommended Source of recruitment: School personnel 1 1 = Yes
Query source10 Integer Recommended Source of recruitment: Other 1 1 = Yes
Query selfref Integer Recommended Source of recruitment was self-referral or other personal referral 0;1 0 = No 1 = Yes
Query fnlstat Integer Recommended Final eligibility status 1::8 1 = Excluded during Gate A phone screen 2 = Excluded during the Gate B1 or B2 procedures 3 = Excluded during the Gate C1 assessment procedures 4 = Discontinued participation between Gates A and B 5 = Discontinued participation between Gates B and C1 6 = Discontinued participation between Gates C1 and C2 7 = Eligible, enrolled, did not attend first treatment session 8 = Eligible, enrolled, first treatment session initiated
Query addno1 Integer Recommended ADD/ADHD History: Does the patient have a previous diagnosis of ADD/ADHD? (Gates A and B) 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query addno2 Integer Recommended ADD/ADHD History: Has the patient ever received treatment for ADD/ADHD? (Gates A and B) 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query addno3 Integer Recommended ADD/ADHD History: Is the patient currently taking a non-prohibited psychostimulant for ADD/ADHD? (Gates A and B) 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query addno4 Integer Recommended ADD/ADHD Psychostimulant Inclusion criteria: Has the patient been on a stable dose of a non-prohibited psychostimulant during the 12 months preceding Gate B? (Gates A and B) 0::2 0 = No; 1 = Yes; 2 = NA
Query addno5 Integer Recommended ADD/ADHD Psychostimulant Inclusion criteria: If the patient is currently taking a non-prohibited psychostimulant for ADD/ADHD, has a written agreement to abide by the TADS protocol been obtained from the patients prescribing physician? (Gate C1) 0::2 0 = No; 1 = Yes; 2 = NA
Query gatea_e Integer Recommended Gate A eligible (entered the Gate) 1 1 = Yes
Query gateb_e Integer Recommended Gate B eligible (entered the Gate) 0;1;99 0 = No; 1 = Yes; 99 = Unknown
Query gatec1_e Integer Recommended Gate C1 eligible (entered the Gate) 0;1;99 0 = No; 1 = Yes; 99 = Unknown
Query gatec2_e Integer Recommended Gate C2 eligible (entered the Gate) 0;1 0 = No 1 = Yes
Query waiver Integer Recommended Patient did not meet all eligibility requirements but a waiver was granted during the caseness panel review 0;1 0 = No 1 = Yes
Query ec1 Integer Recommended Inclusion criteria EC1: Is the patient at least in the 6th grade and at most in the 12th grade at the time of written informed consent? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec2 Integer Recommended Inclusion criteria EC2: Is the patient between 12-17 years of age at the time of written informed consent? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec3 Integer Recommended Inclusion criteria EC3: Has the patient resided with his/her primary caretaker for at least 6 months? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec4 Integer Recommended Inclusion criteria EC4: Is the patients full-scale IQ ?80? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec5 Integer Recommended Inclusion criteria EC5: Does the patient reside in a home with a functional telephone? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec6 Integer Recommended Inclusion criteria EC6: Other than permitted psychostimulants, has the patient been psychotropic medication-free for at least two weeks at the time of written informed consent? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec7 Integer Recommended Inclusion criteria EC7: Have the parent and patient provided written informed consent/assent? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec8 Integer Recommended Inclusion criteria EC8: Does the patient have a DSM- IV diagnosis of current MDD? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec9 Integer Recommended Inclusion criteria EC9: Is the diagnosis of MDD stable and pervasive? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec10 Integer Recommended Inclusion criteria EC10: Is the patients CDRS-R summary score ? 45 at baseline? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec11 Integer Recommended Exclusion criteria EC11: Does the patient have a sibling that was previously enrolled in this study? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec12 Integer Recommended Exclusion criteria EC12: Is the patient non-English speaking? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec13 Integer Recommended Exclusion criteria EC13: Is the primary caretaker non-English speaking? 0::2; -7; -9 0 = No; 1 = Yes; 2 = Not Assessed;-7=refused;-9=unknown
Query ec14 Integer Recommended Exclusion criteria EC14: Is the patient pregnant or breast-feeding? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec15 Integer Recommended Exclusion criteria EC15: Has the patient missed more than 25% of school days in the preceding two months? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec16 Integer Recommended Exclusion criteria EC16: Has the patient been previously enrolled in TADS or another depression treatment study? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec17 Integer Recommended Exclusion criteria EC17: Has the patient participated in a depression assessment study in the past 3 months? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec18 Integer Recommended Exclusion criteria EC18: Is the patient currently receiving neuroleptic treatment? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec19 Integer Recommended Exclusion criteria EC19: Has the patient been hospitalized for any psychiatric indications in the past 3 months? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec20 Integer Recommended Exclusion criteria EC20: Has the patient required chronic neuroleptic treatment in the 6 months prior to Gate C2? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec21 Integer Recommended Exclusion criteria EC21: Is the patient currently taking a psychotropic medication that is on the episodic or chronic prohibited list? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec22 Integer Recommended Exclusion criteria EC22: Is the patient currently taking a prohibited psychostimulant? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec23 Integer Recommended Exclusion criteria EC23: Does the patient have a major neurologic disorder that requires a prohibited medication and/or would interfere with participation in the study? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec24 Integer Recommended Exclusion criteria EC24: Does the patient have a medical condition that requires a prohibited medication and/or would interfere with study participation? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec25 Integer Recommended Exclusion criteria EC25: Has the patient failed a previous trial of fluoxetine judged adequate in dose and duration? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec26 Integer Recommended Exclusion criteria EC26: Does the patient have a history of intolerance to fluoxetine? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec27 Integer Recommended Exclusion criteria EC27: Has the patient failed 2 previous SSRI trials judged adequate in dose and duration? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec28 Integer Recommended Exclusion criteria EC28: Has the patient failed a trial of CBT for depression within the previous 2 years judged adequate by at least 12 treatment sessions over a period of less than 1 year? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec29 Integer Recommended Exclusion criteria EC29: Does the patient have a history of violent or criminal behavior resulting in current legal sanctions? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec30 Integer Recommended Exclusion criteria EC30: Does the patient pose a significant suicidal or homicidal risk? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec31 Integer Recommended Exclusion criteria EC31: Is the patient a victim of ongoing or previously undisclosed child abuse requiring a new DSS report or ongoing DSS supervision? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec32 Integer Recommended Exclusion criteria EC32: Does the patient meet past or current DSM-IV criteria for bipolar affective disorder? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec33 Integer Recommended Exclusion criteria EC33: Does the patient meet DSM-IV criteria for OCD and the disorder is severe enough to require OCD-specific treatment? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec34 Integer Recommended Exclusion criteria EC34: Does the patient meet DSM-IV criteria for primary conduct disorder or haveconduct problems that may affect the patients ability to comply with the study procedures? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec35 Integer Recommended Exclusion criteria EC35: Does the patient meet DSM-IV criteria for autism, PDD, or Aspergers syndrome? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec36 Integer Recommended Exclusion criteria EC36: Does the patient have a past or current diagnosis of psychotic disorder, including schizophrenia-spectrum disorder, psychotic major depression, or an organic psychotic disorder? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec37 Integer Recommended Exclusion criteria EC37: Does the patient meet DSM-IV criteria for a primary or co-primary substance abuse or dependence disorder? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query ec38 Integer Recommended Exclusion criteria EC38: Does the patient meet DSM-IV criteria for ongoing opiate or hallucinogen use? 0::2 0 = No; 1 = Yes; 2 = Not Assessed
Query waiverr Integer Recommended Patient did not meet all eligibility requirements but a waiver was granted during the caseness panel review (not counting EC15) 0;1 0 = No 1 = Yes
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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