Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000117213
Ethics application status
Approved
Date submitted
16/01/2018
Date registered
29/01/2018
Date last updated
14/01/2019
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
MyTeen – Increasing competence and mental health literacy: A mobile-based intervention to support parents of teenagers
Scientific title
MyTeen – Increasing competence and mental health literacy: A mobile-based intervention to support parents of teenagers
Secondary ID [1] 293790 0
None
Universal Trial Number (UTN)
U1111-1207-7960
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Youth mental health 306191 0
Parenting 306192 0
Condition category
Condition code
Public Health 305303 305303 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Participants will receive a tailored programme of text messages (SMS) via their mobile phone. The messages will provide instructional, informational, and emotional support. These will include evidence-based information on the nature and symptoms of depression, understanding treatment options, strategies to improve parent-child communication, parent self-care, and useful links to resources. Input and feedback on the content of the text messages have been obtained from parents and caregivers as part of the development phase via focus groups, and have been fine-tuned to meet the needs of parents of teenagers.

The intervention will be delivered over 4 weeks, with participants receiving one text per day. Participants are able to choose the time period of which they wish to receive the text. Text messages will be one way, however participants are able to discontinue receving the text messages should they wish to by replying "STOP".. Participants will receive all the text-messages free of charge.
Intervention code [1] 300046 0
Prevention
Comparator / control treatment
Care as usual: Participants allocated to the care-as-usual control group will receive no intervention from the research team, and can access alternative services if they so desire. On completion of the 3-months follow up assessment, participants will be offered the SMS mobile-based intervention programme.
Control group
Active

Outcomes
Primary outcome [1] 304463 0
Change in parental competence as measured by the Parental Sense of Competence Scale (PSOC) from baseline to 1-month follow up.
Timepoint [1] 304463 0
Baseline, 1-month follow up
Secondary outcome [1] 342031 0
Change in parental competence as measured by the Parental Sense of Competence Scale (PSOC)
Timepoint [1] 342031 0
3-months follow up
Secondary outcome [2] 342035 0
Parental knowledge of depression - 7-item scale developed by (Fox et al., 2012)
Timepoint [2] 342035 0
Baseline, 1 and 3 months follow up
Secondary outcome [3] 342036 0
Knowledge of where to seek mental health information - measured by a subscale from the Mental Health Literacy Scale, O'Connor & Casey, 2015)
Timepoint [3] 342036 0
Baseline, 1 and 3 months follow up
Secondary outcome [4] 342037 0
Level of parental distress - measured by the Parental Stress Scale (Berry & Jones, 1995)
Timepoint [4] 342037 0
Baseline, 1 and 3 months follow up
Secondary outcome [5] 342038 0
Parent-adolescent communication - measured by the Parent-Adolescent Communication Scale (Olson & Barnes, 1982)
Timepoint [5] 342038 0
Baseline, 1 and 3 months follow up
Secondary outcome [6] 342039 0
Program Satisfaction - measure by 5-items (1) “How much did you like this program?”, (2) “How useful is this program to you?”, (3) "Would you recommend this program to your friends and relatives?” Each item is rated on a five-point Likert scale ranging from strongly disagree to strongly agree.
Timepoint [6] 342039 0
1 month follow up, Intervention participants only

Eligibility
Key inclusion criteria
Parents/Caregivers will be eligible for inclusion in the study if they indicate at screening that they have an adolescent child aged between 10-15 years of age; have access to a mobile phone; are not currently receiving any professional assistance for their own and/or child’s mental health problems; possess adequate knowledge of the English language; and are willing to participate in the study and provide follow-up information at scheduled points of the study. Only one parent from two-parent households will be invited to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents/Caregivers that do not meet the inclusion criteria will be excluded from the study. Parents/Caregivers that show high level of stress as reported by the Parental Stress Index (i.e., equal and/or greater than 45) at screening will be excluded and directed to professional services.

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)
Potential participants can either call or text a phone number to speak with a research assistant or leave their contact details via email. The research assistant will contact the participant and explain the study and ask screening questions to ascertain their eligibility to participant.

Eligible participants who indicate interest will receive an email with study registration details. By clicking on a link in the email they will be able to fill in their registration details and provide e-consent (participants consenting using computer based consent form).

Participants will then be directed to complete the baseline assessment.

Randomisation will be performed upon completion of the baseline assessment, and participants will be notified via email which group they have been allocated to. Those that are randomised into the intervention group will receive the intervention programme the day following the notification email. Participants that are randomised into the care-as-usual group will receive no intervention from the research group.

Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by the trial statistician using block randomisation with variable block sizes of 2 or 4, and stratified by Maori, Pacific and non-Maori/non-Pacific. The randomisation lists will be concealed in database until the point of randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The intervention group receives the intervention straight after completing baseline assessment.
The control group receives no intervention during the trial. The control group receives the intervention after all three sets of questionnaires at the three different time points have been completed.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two-hundred and fourteen participants will be recruited in total (one parent per household). This sample size (107 in each arm), will provide 80% power at p=0.05 to detect an effect size of a 2.5 difference in the Parenting Sense of Competence scale (PSOC) score at 1 month follow up (SD=5.8). This sample size estimate includes an estimated 20% loss to follow up in both trial arms.

Data from the RCT will be entered into a RedCap database, and following cleaning and datalock, extracted into SAS (version 9.4) for analysis. All data analyses will be specified a priori in a statistical analysis plan. No interim analysis will be undertaken. Baseline characteristics: Baseline data collected from all participants will be summarised by treatment group, overall and by ethnicity (Maori and Pasifika). Continuous variables will be presented as numbers observed, means and standard deviations. Categorical variables will be presented as frequencies and percentages. Since any differences between randomised groups at baseline could only have occurred by chance, no formal significance testing will be conducted. Intervention effects: Analysis will be carried out on an intention-to-treat basis. Sensitivity analyses will be undertaken to determine the impact of missing data. Regression models appropriate to continuous and categorical outcome variables will be used to assess the overall intervention effect, adjusting for baseline outcome value and other covariates, if needed. Repeated measures analyses will be conducted on outcomes measured repeatedly over time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/02/2018
Actual
19/03/2018
Date of last participant enrolment
Anticipated
30/09/2018
Actual
17/08/2018
Date of last data collection
Anticipated
31/12/2018
Actual
28/11/2018
Sample size
Target
214
Accrual to date
Final
221
Recruitment outside Australia
Country [1] 9494 0
New Zealand
State/province [1] 9494 0

Funding & Sponsors
Funding source category [1] 298407 0
Government body
Name [1] 298407 0
National Science Challenge: A better start/Cure Kids
Country [1] 298407 0
New Zealand
Primary sponsor type
University
Name
National Institute for Health Innovation, University of Auckland
Address
National Institute for Health Innovation
Level 4, School of Population Health
Tamaki Campus
The University of Auckland
261 Morrin Road
Glen Innes
Auckland 1072
Country
New Zealand
Secondary sponsor category [1] 297543 0
None
Name [1] 297543 0
Address [1] 297543 0
Country [1] 297543 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299405 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 299405 0
Ethics committee country [1] 299405 0
New Zealand
Date submitted for ethics approval [1] 299405 0
Approval date [1] 299405 0
25/09/2017
Ethics approval number [1] 299405 0

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

Contacts
Principal investigator
Name 80286 0
Dr Joanna Ting Wai Chu
Address 80286 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 80286 0
New Zealand
Phone 80286 0
+6421373378
Fax 80286 0
Email 80286 0
[email protected]
Contact person for public queries
Name 80287 0
Joanna Tin Wai Chu
Address 80287 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 80287 0
New Zealand
Phone 80287 0
+6421373378
Fax 80287 0
Email 80287 0
[email protected]
Contact person for scientific queries
Name 80288 0
Joanna Ting Wai Chu
Address 80288 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 80288 0
New Zealand
Phone 80288 0
+6421373378
Fax 80288 0
Email 80288 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All requests for de-identified individual participant data or study documents will be considered.
When will data be available (start and end dates)?
All requests for de-identified individual participant data or study documents will be considered, after publication of the results. Jan 2020 - June 2023
Available to whom?
Data will be available to the requestor, where the proposed use aligns with public good purposes, does not conflict with other requests, or planned use by the Study Steering Committee, and the requestor is willing to sign a data access agreement. Contact will be via the corresponding author.
Available for what types of analyses?
Analyses will be subject to the agreement of the requestor and study steering committee.
How or where can data be obtained?
Data will be made available via electronic means (e.g., usb drive, online portal), subject to the Study Steering Committee approval.


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
EmbaseEffect of MyTeen SMS-Based Mobile Intervention for Parents of Adolescents: A Randomized Clinical Trial.2019https://dx.doi.org/10.1001/jamanetworkopen.2019.11120
N.B. These documents automatically identified may not have been verified by the study sponsor.