Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000248369
Ethics application status
Approved
Date submitted
15/02/2017
Date registered
17/02/2017
Date last updated
1/05/2019
Date data sharing statement initially provided
1/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of a gratitude journal for reducing stress and improving well-being in adolescents with type 1 diabetes
Scientific title
The efficacy of a gratitude journal for reducing stress and improving well-being in adolescents with type 1 diabetes
Secondary ID [1] 291150 0
Nil
Universal Trial Number (UTN)
U111111891348
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 302005 0
Condition category
Condition code
Metabolic and Endocrine 301648 301648 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a randomized controlled trial where participants will be randomly allocated either to write in a gratitude journal for eight weeks (treatment group) or standard care (control group).. The participants in the treatment group will be asked to list three things they are grateful for in their journal on a daily basis. Intervention fidelity will be assessed by asking the participants in the treatment group after the 8-weeks how often they wrote in their journal.
Intervention code [1] 297138 0
Behaviour
Intervention code [2] 297203 0
Treatment: Other
Comparator / control treatment
The control group will continue to receive standard care at the diabetes clinic which includes support from a diabetes team including doctors and diabetes nurses.
Control group
Active

Outcomes
Primary outcome [1] 301040 0
Levels of stress in adolescents: assessed by the short version of the Diabetes Stress Questionnaire for Youths (DSQ) (Delamater, Smith, Lankester & Santiago, 1988).
Timepoint [1] 301040 0
Baseline and at completion of 8-week intervention
Secondary outcome [1] 331563 0
Levels of gratitude: assessed by The Gratitude Questionnaire-6 (McCullough, Emmons & Tsang, 2002).
Timepoint [1] 331563 0
Baseline and at completion of 8-week intervention
Secondary outcome [2] 331564 0
Levels of depression: assessed by The Centre for Epidemiological Studies Depression Scale for Children (CES-DC) (Weissman, Orvaschel & Padian, 1980).
Timepoint [2] 331564 0
Baseline and at completion of 8-week intervention
Secondary outcome [3] 331565 0
Adherence to self-care behaviours: assessed by The Self Care Inventory-Revised Version (SCI-R) (Lewin et al. 2009).
Timepoint [3] 331565 0
Baseline and at completion of 8-week intervention
Secondary outcome [4] 331566 0
Quality of life: assessed by The ‘Impact of Diabetes’ subscale from The Diabetes Quality of Life for Youths (Ingersoll & Marrero, 1991).
Timepoint [4] 331566 0
Baseline and at completion of 8-week intervention
Secondary outcome [5] 331567 0
Metabolic control (glycosylated hemoglobin/HbA1c levels assessed at the diabetes clinic as part of standard care).
Timepoint [5] 331567 0
Baseline and at completion of 8-week intervention
Secondary outcome [6] 331568 0
Parental stress: assessed by Pediatric Inventory for Parents (Streisand, Braniecki, Tercyak, & Kazak, 2001).
Timepoint [6] 331568 0
Baseline and at completion of 8-week intervention
Secondary outcome [7] 335219 0
Adherence to the intervention for those in the intervention group and their parents: assessed by asking how often they wrote in the gratitude journal
Timepoint [7] 335219 0
At completion of 8-week intervention
Secondary outcome [8] 335220 0
Qualitative questions asking about experience with the gratitude journal for both adolescents in the intervention condition and their parents: assessed by asking:
Questions for adolescents:
What was your experience writing in the gratitude journal?
What was it about this experience that you liked or disliked?
Now that you know about a gratitude journal, are you likely to use a gratitude journal in the future?
Questions for parents:
Do you have any general comments about your child’s experience writing in the gratitude journal?
What was it about this experience that you think your child liked or disliked?
Now that you and your child know about a gratitude journal, do you think your child is likely to continue using one in the future?
Timepoint [8] 335220 0
At completion of 8-week intervention

Eligibility
Key inclusion criteria
Adolescents will be eligible for inclusion in the intervention if they meet the following criteria: (1) are aged 10-16 years, and (2) diagnosed with type 1 diabetes more than 6 months ago.
Minimum age
10 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: (1) non-English speaking adolescents, (2) children with developmental disorders (e.g. Autism Spectrum Disorder), and (3) children diagnosed with a serious mental disorder requiring ongoing treatment (e.g. psychosis, eating disorders).
The only exclusion criteria for parents/primary caregivers is that they are able to complete forms in English and provide informed consent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based random number generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pearsons correlations will be used to explore the relationship between the different outcome measures, demographic characteristics, disease characteristics, and current insulin regimen. Independent samples t-tests will be employed to assess group differences at follow-up on all the measures. A mixed design analysis of variance (ANOVA) will be used to assess group differences as well as within-group differences in the outcome measures. Multiple linear regression will be used to examine which measures are associated with adolescent and parental stress levels as well as adolescent glycaemic control.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/03/2017
Actual
3/04/2017
Date of last participant enrolment
Anticipated
26/05/2017
Actual
29/05/2017
Date of last data collection
Anticipated
28/07/2017
Actual
21/08/2017
Sample size
Target
160
Accrual to date
Final
160
Recruitment outside Australia
Country [1] 8650 0
New Zealand
State/province [1] 8650 0
Auckland

Funding & Sponsors
Funding source category [1] 295587 0
University
Name [1] 295587 0
The University of Auckland
Country [1] 295587 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Dept. of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 294419 0
None
Name [1] 294419 0
Address [1] 294419 0
Country [1] 294419 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296909 0
Health and Disability Ethics Committees
Ethics committee address [1] 296909 0
Ethics committee country [1] 296909 0
New Zealand
Date submitted for ethics approval [1] 296909 0
10/11/2016
Approval date [1] 296909 0
30/01/2017
Ethics approval number [1] 296909 0
16/CEN/177

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72402 0
Dr Anna Serlachius
Address 72402 0
Dept. of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142
Country 72402 0
New Zealand
Phone 72402 0
+64 09 9233073
Fax 72402 0
Email 72402 0
[email protected]
Contact person for public queries
Name 72403 0
Anna Serlachius
Address 72403 0
Dept. of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142
Country 72403 0
New Zealand
Phone 72403 0
+64 09 9233073
Fax 72403 0
Email 72403 0
[email protected]
Contact person for scientific queries
Name 72404 0
Anna Serlachius
Address 72404 0
Dept. of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142
Country 72404 0
New Zealand
Phone 72404 0
+64 09 9233073
Fax 72404 0
Email 72404 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA pilot randomized controlled trial of a gratitude intervention for adolescents with Type 1 diabetes.2020https://dx.doi.org/10.1111/dme.14078
N.B. These documents automatically identified may not have been verified by the study sponsor.