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Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.


Diabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS)

CDISC ReferenceQuestionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name


QRS Permission StatusApproved
TeamType 1 Diabetes Standards team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.

Revision History

1.0 Draft

© 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Diabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS) questionnaire.

CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this questionnaire is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at:

These specific implementation details for this questionnaire are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at:

The CDISC Intellectual Property Policy can be found on the CDISC website at:

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.

2 Copyright Status

Behavioral Diabetes Institute owns the copyright for the PARENT-DDS instrument and has granted CDISC permission to include this supplement in the CDISC collection of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the questionnaire. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Information for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at:

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges Behavioral Diabetes Institute for the approval to include the PARENT-DDS in the CDISC data standards.

Reference for the Diabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS):

Hessler D, Fisher L, Polonsky W, Johnson N. Understanding the areas and correlates of diabetes-related distress in parents of teens with type 1 diabetes. Journal of Pediatric Psychology 2016; 41(7): 750-758.

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the PARENT-DDS are listed below.

The PARENT-DDS is a 20-item self-report scale that has 4 dimensions of parent-related distress: personal distress, teen management distress, parent/teen relationship distress, and healthcare team distress. A total scale score and 4 subscale scores are captured.

  1. Respondents respond to each item using a 5-point verbal rating scale from "Not at all" to "A great deal". For the PARENT-DDS, QSORRES is populated with the text description of the rating scale response chosen.

  2. For the PARENT-DDS no score is displayed for any item on the questionnaire; however, the reference article includes the standardized representation of 0 (i.e., "Not at all”) through 4 (i.e., “A great deal"). Because (a) electronic data submission is expected frequently, (b) instructions for scoring are provided in the reference article, and (c) the numeric score for each question is expected to be submitted with the data, CDISC will represent the standardized scores in QSSTRESC and QSSTRESN.

  3. The time period of evaluation for the PARENT-DDS is populated in the QSEVLINT field in ISO 8601 format  when the evaluation interval can be precisely described as duration. The evaluation interval for the PARENT-DDS is the past 1 month.

  4. The PARENT-DDS instrument includes a total scale score and 4 subscale scores that are considered as captured data on the CRF and are not considered as derived in the example below. The total scale score and 4 subscale scores are considered as captured data when provided as part of Electronic Data Transfer (eDT) and is not considered as derived in the example below.

    1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score written on a CRF will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to Y. However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null (See SDTMIG Section, Origin Metadata for Variables).

  5. Terminology

    1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the PARENT-DDS QS Domain Model

The PARENT-DDS example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for a PARENT-DDS instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. This result is then transformed into the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.

We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.

The table represents the items from the PARENT-DDS form. Subscale scores and a total scale score are represented in rows 21-35.



1STUDYXQS2324-P00011DDS0201DDS02-Don't Work Well TogetherPARENT-DDSSomewhat22Y12015-05-15-P1M
2STUDYXQS2324-P00012DDS0202DDS02-Unappreciated for Ways I HelpPARENT-DDSA lot33Y12015-05-15-P1M
3STUDYXQS2324-P00013DDS0203DDS02-Trust Teen Take Care of DiabetesPARENT-DDSSomewhat22Y12015-05-15-P1M
4STUDYXQS2324-P00014DDS0204DDS02-Low Blood Sugars Away From HomePARENT-DDSA little11Y12015-05-15-P1M
5STUDYXQS2324-P00015DDS0205DDS02-Teen Ignore/Forget DiabetesPARENT-DDSA little11Y12015-05-15-P1M
6STUDYXQS2324-P00016DDS0206DDS02-Taking Too Much of My EnergyPARENT-DDSSomewhat22Y12015-05-15-P1M
7STUDYXQS2324-P00017DDS0207DDS02-Help Teen Is a BattlePARENT-DDSA lot33Y12015-05-15-P1M
8STUDYXQS2324-P00018DDS0208DDS02-Low Blood Sugars When SleepingPARENT-DDSA little11Y12015-05-15-P1M

DDS02-No One Notices Diabetes Hard on Me

PARENT-DDSA little11Y12015-05-15-P1M
10STUDYXQS2324-P000110DDS0210DDS02-Doesn't Do Enough Manage DiabetesPARENT-DDSSomewhat22Y12015-05-15-P1M
11STUDYXQS2324-P000111DDS0211DDS02-Teen Doesn't Have Right DoctorPARENT-DDSNot at all00Y12015-05-15-P1M
12STUDYXQS2324-P000112DDS0212DDS02-Blame Me If Not Well-controlledPARENT-DDSA little11Y12015-05-15-P1M
13STUDYXQS2324-P000113DDS0213DDS02-Leave Home and Cannot Protect HimPARENT-DDSA little11Y12015-05-15-P1M
14STUDYXQS2324-P000114DDS0214DDS02-Teen Ignores My SuggestionsPARENT-DDSSomewhat22Y12015-05-15-P1M
15STUDYXQS2324-P000115DDS0215DDS02-Lack Support From Friends/FamilyPARENT-DDSNot at all00Y12015-05-15-P1M
16STUDYXQS2324-P000116DDS0216DDS02-Doesn't Get Expert Medical HelpPARENT-DDSNot at all00Y12015-05-15-P1M
17STUDYXQS2324-P000117DDS0217DDS02-Motivate Teen Take Care DiabetesPARENT-DDSA little11Y12015-05-15-P1M
18STUDYXQS2324-P000118DDS0218DDS02-Teen Not Prepared Once AdultPARENT-DDSSomewhat22Y12015-05-15-P1M
19STUDYXQS2324-P000119DDS0219DDS02-Only One Takes ResponsibilityPARENT-DDSA little11Y12015-05-15-P1M
20STUDYXQS2324-P000120DDS0220DDS02-My Nagging Hurting RelationshipPARENT-DDSA little11Y12015-05-15-P1M
21STUDYXQS2324-P000121DDS0221DDS02-Total DDS Score: SumPARENT-DDS272727Y12015-05-15-P1M
22STUDYXQS2324-P000122DDS0222DDS02-Total DDS Score: MeanPARENT-DDS1.351.351.35Y12015-05-15-P1M
23STUDYXQS2324-P000123DDS0223DDS02-Total DDS Score: ModeratePARENT-DDSnoN
24STUDYXQS2324-P000124DDS0224DDS02-Personal Distress: SumPARENT-DDS888Y12015-05-15-P1M
25STUDYXQS2324-P000125DDS0225DDS02-Personal Distress: MeanPARENT-DDS1.31.31.3Y12015-05-15-P1M
26STUDYXQS2324-P000126DDS0226DDS02-Personal Distress: ModeratePARENT-DDSnoN
27STUDYXQS2324-P000127DDS0227DDS02-Teen Management Distress: SumPARENT-DDS555Y12015-05-15-P1M
28STUDYXQS2324-P000128DDS0228DDS02-Teen Management Distress: MeanPARENT-DDS1.251.251.25Y12015-05-15-P1M
29STUDYXQS2324-P000129DDS0229DDS02-Teen Management Distress: ModeratePARENT-DDSnoN
30STUDYXQS2324-P000130DDS0230DDS02-Parent/Teen Rel Distress: SumPARENT-DDS141414Y12015-05-15-P1M
31STUDYXQS2324-P000131DDS0231DDS02-Parent/Teen Rel Distress: MeanPARENT-DDS1.751.751.75Y12015-05-15-P1M
32STUDYXQS2324-P000132DDS0232DDS02-Parent/Teen Rel Distress: ModeratePARENT-DDSnoN
33STUDYXQS2324-P000133DDS0233DDS02-Healthcare Team Distress: SumPARENT-DDS000Y12015-05-15-P1M
34STUDYXQS2324-P000134DDS0234DDS02-Healthcare Team Distress: MeanPARENT-DDS000Y12015-05-15-P1M
35STUDYXQS2324-P000135DDS0235DDS02-Healthcare Team Distress: ModeratePARENT-DDSnoN

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

QSTESTCD = "DDS0201" QSTEST = "DDS02-Don't Work Well Together" through

QSTESTCD = "DDS0220" QSTEST = "DDS02-My Nagging Hurting Relationship"

Not at all
A little
A lot
A great deal

QSTESTCD = "DDS0223" QSTEST = "DDS02-Total DDS Score: Moderate"

QSTESTCD = "DDS0226" QSTEST = "DDS02-Personal Distress: Moderate"

QSTESTCD = "DDS0229" QSTEST = "DDS02-Teen Management Distress: Moderate"

QSTESTCD = "DDS0232" QSTEST = "DDS02-Parent/Teen Rel Distress: Moderate"

QSTESTCD = "DDS0235" QSTEST = "DDS02-Healthcare Team Distress: Moderate"


End of Document

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