Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001258842
Ethics application status
Approved
Date submitted
5/08/2021
Date registered
16/09/2021
Date last updated
16/09/2021
Date data sharing statement initially provided
16/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Gratitude on Wellbeing in Adolescence
Scientific title
Evaluation of a gratitude intervention on adolescent sleep onset latency and wellbeing.
Secondary ID [1] 304323 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Not applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep problems 322077 0
Condition category
Condition code
Mental Health 319796 319796 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gratitude Intervention
Participants will be asked to spend 15 minutes each weekday evening (mon-fri) writing about a positive event for which they are grateful for two weeks.
Intervention code [1] 320677 0
Lifestyle
Comparator / control treatment
Waitlist Control Group
Participants in the waitlist control group will receive the intervention after delivery of the final (3rd) survey which is sent out two weeks after beginning the intervention.
Control group
Active

Outcomes
Primary outcome [1] 327659 0
Sleep Onset Latency (minutes) measured via the School Sleep Habits Survey (SSHS)
Timepoint [1] 327659 0
Baseline, one week, and two weeks after intervention commencement.
Secondary outcome [1] 396141 0
Pre-sleep anxiety assessed by Sleep Anticipatory Anxiety Questionnaire for Adolescents (SAAQ-A)
Timepoint [1] 396141 0
Baseline, one week, and two weeks after intervention commencement.
Secondary outcome [2] 396142 0
Mood and depression symptoms measured by the Short Mood and Feelings Questionnaire (SMFQ)
Timepoint [2] 396142 0
Baseline, one week, and two weeks after intervention commencement.
Secondary outcome [3] 396143 0
Difficulty initiating sleep, measured also by the School Sleep Habits Survey (SSHS)
Timepoint [3] 396143 0
Baseline, one week, and two weeks after intervention commencement.

Eligibility
Key inclusion criteria
High school students in South Australian schools in years 10 through 12.
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Students will be assigned to either the intervention or control group via their class (i.e., one class will be assigned to the intervention condition, another will be assigned to the wait-list control)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed model regressions will be used which take into account missing data. Target total sample =200

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
2/08/2021
Date of last participant enrolment
Anticipated
Actual
7/09/2021
Date of last data collection
Anticipated
29/10/2021
Actual
Sample size
Target
200
Accrual to date
Final
263
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 34858 0
5064 - Glen Osmond
Recruitment postcode(s) [2] 34859 0
5067 - Kent Town
Recruitment postcode(s) [3] 34864 0
5330 - Waikerie
Recruitment postcode(s) [4] 34865 0
5245 - Verdun

Funding & Sponsors
Funding source category [1] 308698 0
University
Name [1] 308698 0
Flinders University
Country [1] 308698 0
Australia
Primary sponsor type
Individual
Name
Tahlia Cross
Address
Flinders University
Sturt Road, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 309584 0
Individual
Name [1] 309584 0
Michael Gradisar
Address [1] 309584 0
Flinders University
Sturt Road, Bedford Park SA 5042
Country [1] 309584 0
Australia
Other collaborator category [1] 281806 0
Individual
Name [1] 281806 0
Michal Kahn
Address [1] 281806 0
Flinders University
Sturt Road, Bedford Park SA 5042
Country [1] 281806 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308620 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 308620 0
Ethics committee country [1] 308620 0
Australia
Date submitted for ethics approval [1] 308620 0
15/03/2021
Approval date [1] 308620 0
19/04/2021
Ethics approval number [1] 308620 0
4265

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

Contacts
Principal investigator
Name 111346 0
Miss Tahlia Cross
Address 111346 0
Flinders University
Sturt Road, Bedford Park SA 5042
Country 111346 0
Australia
Phone 111346 0
+61 418165789
Fax 111346 0
Email 111346 0
[email protected]
Contact person for public queries
Name 111347 0
Michael Gradisar
Address 111347 0
Flinders University
Sturt Road, Bedford Park SA 5042
Country 111347 0
Australia
Phone 111347 0
+61 882012324
Fax 111347 0
Email 111347 0
[email protected]
Contact person for scientific queries
Name 111348 0
Michael Gradisar
Address 111348 0
Flinders University
Sturt Road, Bedford Park SA 5042
Country 111348 0
Australia
Phone 111348 0
+61 882012324
Fax 111348 0
Email 111348 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11774Ethical approval    382072-(Uploaded-26-05-2021-16-26-18)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.