Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000405213
Ethics application status
Approved
Date submitted
6/03/2009
Date registered
2/06/2009
Date last updated
3/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Memo multimedia mobile phone lifeskills programme for teenagers
Scientific title
A randomised controlled trial of a multimedia mobile phone programme to reduce depressive symptoms in adolescents compared to an attention control mobile phone programme
Secondary ID [1] 273321 0
Robyn Whittaker
Universal Trial Number (UTN)
Trial acronym
ADAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depressive symptoms 4427 0
Condition category
Condition code
Mental Health 4694 4694 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multimedia programme delivered solely by mobile phone that has been developed by experts based on cognitive behavioural therapy. Two text/video/animated messages will be sent each day for two months, with access to the information via a mobile website for up to 12 months.
Intervention code [1] 4155 0
Behaviour
Intervention code [2] 4170 0
Prevention
Comparator / control treatment
An attention control programme with the same frequency of text/video messages, animations (two messages/day for two months) & access to a mobile website (for 12 months).
Control group
Placebo

Outcomes
Primary outcome [1] 5560 0
Change in depressive symptoms as measured by the Child Depression Rating Scale-Revised (CDRS-R).
Timepoint [1] 5560 0
Post-programme and 12 months post-randomisation
Secondary outcome [1] 9367 0
Self-rated depressive symptoms assessed via the Reynolds Adolescent Depression Score (RADS-2), Moods & Feelings Questionnaire
Timepoint [1] 9367 0
Post-programme and 12 months post-randomisation
Secondary outcome [2] 9368 0
Overall functioning and quality of life assessed by the Pediatric Quality of Life Questionnaire (PQ-les-Q)
Timepoint [2] 9368 0
post-programme and 12 months post-randomisation

Eligibility
Key inclusion criteria
Years 9-12 at school; mobile phone capable of receiving video messages; Vodafone customer; able to provide consent
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Screening tests identify depression or risk of self-harm at baseline

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Students at participating schools invited to participate; provide informed consent; complete baseline data collection; receive run-in programme; complete assessment by Research Assistants (RA); randomised centrally by computer after RA assessment data entered.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer allocation using a stratified minimisation randomisation to ensure balance for possible prognostic factors, such as sex, ethnicity (Maori/Pacific v. non-Maori/Pacific) and school.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
790
Accrual to date
Final
Recruitment outside Australia
Country [1] 1607 0
New Zealand
State/province [1] 1607 0

Funding & Sponsors
Funding source category [1] 4617 0
Government body
Name [1] 4617 0
Health Research Council of New Zealand
Country [1] 4617 0
New Zealand
Primary sponsor type
University
Name
Clinical Trials Research Unit
Address
University of Auckland
Private Bag 92019
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 4163 0
University
Name [1] 4163 0
Dept of Psychological Medicine
Address [1] 4163 0
University of Auckland
Private Bag 92019
Auckland 1010
Country [1] 4163 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6660 0
Northern Region Y Ethics Committee
Ethics committee address [1] 6660 0
3rd floor, Bank of New Zealand (BNZ) building
354 Victoria St
PO Box 1031
Hamilton 2001
Ethics committee country [1] 6660 0
New Zealand
Date submitted for ethics approval [1] 6660 0
Approval date [1] 6660 0
23/09/2008
Ethics approval number [1] 6660 0
NTY/08/09/088

Summary
Brief summary
A study to determine if a multimedia mobile phone lifeskills programme can help prevent depressive symptoms in adolescents.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29346 0
Address 29346 0
Country 29346 0
Phone 29346 0
Fax 29346 0
Email 29346 0
Contact person for public queries
Name 12593 0
Robyn Whittaker
Address 12593 0
Clinical Trials Research Unit
University of AUckland
Private Bag 92019
Auckland 1010
Country 12593 0
New Zealand
Phone 12593 0
+6493737999
Fax 12593 0
Email 12593 0
[email protected]
Contact person for scientific queries
Name 3521 0
Robyn Whittaker
Address 3521 0
Clinical Trials Research Unit
University of AUckland
Private Bag 92019
Auckland 1010
Country 3521 0
New Zealand
Phone 3521 0
+6493737999
Fax 3521 0
Email 3521 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseMEMO--a mobile phone depression prevention intervention for adolescents: development process and postprogram findings on acceptability from a randomized controlled trial.2012https://dx.doi.org/10.2196/jmir.1857
N.B. These documents automatically identified may not have been verified by the study sponsor.