Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000248268p
Ethics application status
Submitted, not yet approved
Date submitted
15/12/2017
Date registered
15/02/2018
Date last updated
15/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Tuning in to Teens Whole School Approach: Examining the efficacy of an emotion-focused intervention aimed at adolescents, parents, and teachers in preventing youth mental health difficulties
Scientific title
Tuning in to Teens Whole School Approach: A randomised control trial of a multi-systemic
intervention aimed at adolescents, parents, and teachers in preventing mental health problems in secondary students
Secondary ID [1] 293584 0
None
Universal Trial Number (UTN)
U1111-1206-4879
Trial acronym
TINT WSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
emotional competence 305828 0
emotion socialisation 305829 0
Condition category
Condition code
Mental Health 305073 305073 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 305421 305421 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The TINT WSA program is a program aimed to improve teacher, parent and adolescent emotional competence and emotion socialisation, with the aim of improving relationships and reducing mental health difficulties. The program will be delivered to parents, teachers and year 8 and 9 students during term 3 in the first or second year of the school joining the study – depending on which condition the school is randomised into (e.g., immediate start or one year delayed start).
TINT WSA includes:
• a one-day teacher training (Teachers Tuning in to Students) plus two 90-minute follow-up sessions. The sessions are adapted from the evidence-based Tuning in to Teens parenting Program. The one-day teacher training will aim to teach teachers skills in emotion socialisation, including skills in awareness, understanding and managing their own emotions and responding supportively when students are emotional. The first follow-up session will teach skills in helping students who present with anxiety, including excessive reassurance seeking. The second session will teach skills in responding to students anger, managing conflict and problem solving. The skills will be taught in seminar style by the program author, who is a trained Tuning in to Teens faciltiator, using psycho-education, watching DVD material, role-play and reading additional information provided to teachers. All three sessions are deliverd within a term at a time agreed by the school.
• five 50-60 min classes for year 8-9 students (Tuning in to Teens for Teens) delivered by the student wellbeing team of the school who will receive a one-day training in delivery of the scripted/manualised program sessions and will be offered supervision throughout delivery of the sessions; The student sessions will focus on teaching skills in awareness and understanding of emotions in the first two sessions; skills in understanding and managing anxiety in the third session; skills in understanding and managing anger in the fourth session; and skills in awareness and responding to others emotions in the fifth session. The skills will be taught via activities and games, as well as role-plays and brief lectures.
• three 90-minute evening seminar sessions for parents are a 3-session version of the 6-session evidence-based Tuning in to Teens program (see the California Clearinghouse Website http://www.cebc4cw.org/program/tuning-in-to-teens-tint/detailed for more information). The sessions are delivered by one of the program authors who is also an accredited Tuning in to Teens trainer using lecture, activities and watching DVD material..

All sessions are delivered within one school term, at times determined by the school. Recommendations put forward to the school are that student sessions are held weekly, parent seminars are held weekly, and the teacher 90-minute follow-up sessions are held either weekly or fourtnightly, following on from the one-day teacher training day.
Intervention code [1] 299870 0
Treatment: Other
Intervention code [2] 300132 0
Behaviour
Intervention code [3] 300133 0
Prevention
Comparator / control treatment
Our comparator/waitlist control group will receive treatment as usual. This may include other interventions the school is currently using, or individual treatment as usual outside of school. Comparator/waitlist control schools will receive the Tuning in to Teens Whole School approach once they have completed final questionnaires, twelve months after completing baseline questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 304265 0
The primary outcome is emotional competence as indexed by the Difficulties in Emotion Regulation self-report questionnaire.
Timepoint [1] 304265 0
Baseline and 12 months later
Primary outcome [2] 304266 0
Another primary outcome is emotion socialisation as indexed by self-report questionnaire, as measured by the Emotions as a Child Questionnaire.
Timepoint [2] 304266 0
Baseline and 12 months follow up
Secondary outcome [1] 341424 0
One secondary outcome is parent-adolescent conflict, as measured via the Conflict-Behavior Questionnaire (Robin & Foster, 1989) self-report questionnaires completed by the parent and the adolescent
Timepoint [1] 341424 0
Baseline and 12 months follow up
Secondary outcome [2] 341425 0
Another secondary outcome is mental health as measured via questionnaires (DASS - Depression, Anxiety and Stress Scale; Spence anxiety scale)
Timepoint [2] 341425 0
Baseline and 12 months follow up

Eligibility
Key inclusion criteria
Inclusion criteria is self-selected proficiency in the English language for parents. There are no exclusion criteria. Students who are not proficient in the English language or who have developmental/behavioural or cognitive issues will remain in class and participate to the best of their ability. Only teachers, parents and students employed or enrolled in participating schools are eligible to take part.
Minimum age
13 Years
Maximum age
80 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
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer randomiser will be used to randomise the four schools one pair at a time.
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
The sample will consist of year 8 and 9 students (age range: 13 to 16 years), their parents and the school’s teaching staff from four large, co-ed, government secondary schools in Melbourne. Schools will be matched (using My School Website) for size, percentage of English as a Second Language students, student distributions based on NAPLAN (National Assessment Program Literacy and Numeracy) scores, and Index of Community Socio-educational Advantage (ICSEA) scores. ICSEA scores represent the relative magnitude of influence of key factors in a student’s family background (such as parents’ occupation, school education or non-school education), as well as key factors regarding the school itself (such as geographic location and the proportion of indigenous students it caters for). Students in this age range were chosen because it is just prior to the peak time for parent-adolescent relationship difficulties and the onset of adolescent mental health problems. Both parents will be invited to participate in the program but only the primary caregiver will fill in questionnaires. The maximum number of participants will depend on the size of the school. We aim to invite four schools with about 90-130 teaching staff per school, and about 333 (based on total school size of 1000) year eight and nine students and their parents per school. Our past research has shown that parent up-take ranges from 40-50%. Our two pilot studies have had 100% uptake from teachers and 50-85% uptake rate for parents and students, respectively. Therefore, the maximum anticipated participants for teachers is 520 (130 per school), the maximum anticipated number of participants for year eight and nine parents and students is 166.7 parents per school (666.6 for total sample) and 283.33 adolescents (1133.33 total sample).
For teacher individual-level design, a sufficient number is 176 persons per arm to determine a change of a small effect size d=0.30 with 80% power and an alpha of .05 translating to a post-dropout sample size of 352. As teachers are recruited from four schools, school can be added as a covariate to control for any school-membership related effect.
Parents and students in this trial are nested within clusters (classes, within schools) when the intervention is delivered, which may affect the results. Therefore we calculated the effect of clustering on the power, taking into account the intracluster correlation coefficient (ICC), varying cluster sizes and the expected effect. Data from the internal pilot was used to estimate the ICC and assess the likely mean and SD of cluster sizes. The ICC for emotion socialisation and emotional competence in the pilot study varied from 0.033 to 0.059 respectively and we used a mean cluster size of 17 (SD=3.84). This resulted in design effects of 1.56 and 2.00, giving us 80 % power to detect d=0.3 with a sample sizes of 549 and 703, for our primary outcome measures, respectively.

Baseline data will be used to examine relationships between variables for the teacher-reported data, and between parent and student reported assessment information. Post-intervention satisfaction questionnaires will be used to determine perceptions of the intervention. Depending on intra class correlations, ANCOVA or Multilevel Mixed Models will be used to compare parents/teachers/students in the intervention versus control condition, to take into account the nested data structure.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2018
Actual
Date of last participant enrolment
Anticipated
31/07/2019
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 298201 0
University
Name [1] 298201 0
Mindful, Centre for Training and Research in Developmental Health; The University of Melbourne
Country [1] 298201 0
Australia
Primary sponsor type
University
Name
Mindful, Centre for Training and Research in Developmental Health; The University of Melbourne
Address
Building C, 50 Flemington St, Travancore, Victoria, 3032
Country
Australia
Secondary sponsor category [1] 297355 0
None
Name [1] 297355 0
Address [1] 297355 0
Country [1] 297355 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299210 0
Melbourne University Human Research Ethics Committee
Ethics committee address [1] 299210 0
Ethics committee country [1] 299210 0
Australia
Date submitted for ethics approval [1] 299210 0
15/12/2017
Approval date [1] 299210 0
Ethics approval number [1] 299210 0

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

Contacts
Principal investigator
Name 79666 0
Dr Christiane Kehoe
Address 79666 0
Mindful, Centre for Training and Research in Developmental Health
Building C, 50 Flemington St, Travancore, Victoria, 3032, Australia.
Country 79666 0
Australia
Phone 79666 0
+61393710207
Fax 79666 0
Email 79666 0
[email protected]
Contact person for public queries
Name 79667 0
Christiane Kehoe
Address 79667 0
Mindful, Centre for Training and Research in Developmental Health
Building C, 50 Flemington St, Travancore, 3032, Victoria, Australia.
Country 79667 0
Australia
Phone 79667 0
+61393710207
Fax 79667 0
Email 79667 0
[email protected]
Contact person for scientific queries
Name 79668 0
Christiane Kehoe
Address 79668 0
Mindful, Centre for Training and Research in Developmental Health
Building C, 50 Flemington St, Travancore, 3032, Victoria, Australia.
Country 79668 0
Australia
Phone 79668 0
+61393710207
Fax 79668 0
Email 79668 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23584Study protocol  [email protected]
23585Statistical analysis plan  [email protected]

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.