Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000137392
Ethics application status
Approved
Date submitted
19/01/2017
Date registered
25/01/2017
Date last updated
10/12/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does social media literacy mitigate impacts of social media in adolescents?
Scientific title
Does social media literacy mitigate impacts of social media in adolescents?
Secondary ID [1] 290972 0
None
Universal Trial Number (UTN)
U1111-1191-8185
Trial acronym
SML
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body dissatisfaction 301719 0
Disordered eating 301720 0
Mental health problems 301721 0
Condition category
Condition code
Mental Health 301418 301418 0 0
Eating disorders
Public Health 301449 301449 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A four lesson, universal, social media literacy intervention for early adolescents, will be delivered by research personnel, face-to-face, in grade 7 and 8 classrooms. Each lesson will be of 45-50 minutes long and one lesson will be conducted in each of four consecutive weeks. The first social media literacy lesson will include classroom activities to explore motives for social media posting to inform critical social media use. These activities will include examination of postings on social media including advertising and celebrity posts. In the second lesson, the realism of social media images and the effect of viewing images on how students feel about themselves will be explored. In the third lesson,students will find social media images with positive and negative feedback and examine emotions associated with feedback and motives for different types of feedback. They will create a non-appearance focused social media profile. In the final lesson, students will work in small group to create a social media campaign using the social media literacy skills they have gained. To ensure treatment fidelity, staff delivering the intervention will be trained and a sample of lessons will be recorded.
Intervention code [1] 296924 0
Prevention
Intervention code [2] 296948 0
Behaviour
Comparator / control treatment
No intervention control group - lessons as usual. Students will receive their usual English, health or home lessons (depending on the subject in which the social media literacy program is placed) and will not receive any information about the effects of viewing social media.
Control group
Active

Outcomes
Primary outcome [1] 300806 0
Body satisfaction/dissatisfaction assessed using a reliable and valid questionnaire (Weight and Shape Concerns subscales of the Eating Disorder Examination Questionnaire).
Timepoint [1] 300806 0
6-8 weeks post baseline
Primary outcome [2] 300807 0
Disordered eating symptoms will be assessed. Dietary restraint with the DEBQ Dietary Restraint subscale (van Strien et al., 1986) and body change behaviours with the Body Change Questionnaire (Ricciardelli, & McCabe, 2001), These are both valid and reliable questionnaire measures in early adolescents.
Timepoint [2] 300807 0
6-8 weeks post-baseline
Secondary outcome [1] 330929 0
Depressed mood will be assessed with the valid and reliable questionnaire, the CESDR-10 (Haroz et al., 2014).
Timepoint [1] 330929 0
6-8 weeks post baseline assessment

Eligibility
Key inclusion criteria
All girls and boys in grade 7 and 8 classes. These students usually range in age from 11 to 14, however there are occasions when younger and older students are in these classes and these students will not be excluded.
Minimum age
10 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no exclusion criteria.

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



Intervention assignment
Parallel
Other design features
Within schools, grade 7 and 8 year levels will be randomised to either receive the intervention or be in the control condition. (Block randomisation).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Multi-level modelling to account for multiple schools, within class clustering, repated assessments and missing data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2017
Actual
16/10/2017
Date of last participant enrolment
Anticipated
25/02/2019
Actual
10/12/2018
Date of last data collection
Anticipated
27/03/2020
Actual
Sample size
Target
700
Accrual to date
Final
775
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295386 0
Government body
Name [1] 295386 0
Australian Research Council
Country [1] 295386 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Melbourne
Vic 3086
Country
Australia
Secondary sponsor category [1] 294208 0
None
Name [1] 294208 0
Address [1] 294208 0
Country [1] 294208 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296721 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 296721 0
Ethics committee country [1] 296721 0
Australia
Date submitted for ethics approval [1] 296721 0
27/02/2017
Approval date [1] 296721 0
26/02/2018
Ethics approval number [1] 296721 0
HEC17-020
Ethics committee name [2] 302296 0
Department of Education & Training
Ethics committee address [2] 302296 0
Ethics committee country [2] 302296 0
Australia
Date submitted for ethics approval [2] 302296 0
27/02/2017
Approval date [2] 302296 0
26/04/2017
Ethics approval number [2] 302296 0
2017_003388

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

Contacts
Principal investigator
Name 71878 0
Prof Susan J Paxton
Address 71878 0
School of Psychology and Public Health
La Trobe University
Melbourne
Vic 3086
Country 71878 0
Australia
Phone 71878 0
+61 (0)3 94791736
Fax 71878 0
Email 71878 0
[email protected]
Contact person for public queries
Name 71879 0
Susan J Paxton
Address 71879 0
School of Psychology and Public Health
La Trobe University
Melbourne
Vic 3086
Country 71879 0
Australia
Phone 71879 0
+61 (0)3 94791736
Fax 71879 0
Email 71879 0
[email protected]
Contact person for scientific queries
Name 71880 0
Susan J Paxton
Address 71880 0
School of Psychology and Public Health
La Trobe University
Melbourne
Vic 3086
Country 71880 0
Australia
Phone 71880 0
+61 (0)3 94791736
Fax 71880 0
Email 71880 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?

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
EmbaseOutcomes of a cluster randomized controlled trial of the some social media literacy program for improving body image-related outcomes in adolescent boys and girls.2021https://dx.doi.org/10.3390/nu13113825
N.B. These documents automatically identified may not have been verified by the study sponsor.