Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001594819
Ethics application status
Approved
Date submitted
30/09/2021
Date registered
22/11/2021
Date last updated
26/05/2024
Date data sharing statement initially provided
22/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot RCT of a family program for reducing bullying victimisation and mental illness of adolescents
Scientific title
Pilot RCT of a relationships focused cognitive behavioural family intervention for reducing bullying victimisation and mental illness of adolescents
Secondary ID [1] 305332 0
QIMR Berghofer Protocol Number: 3545
Universal Trial Number (UTN)
Trial acronym
TCTP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent bullying victimisation 323650 0
Adolescent mental illness 323651 0
Condition category
Condition code
Mental Health 321189 321189 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The design is a randomised controlled trial with two arms. The intervention arm is a novel cognitive behavioural intervention designed for this study; it aims to strengthen the adolescent’s supportive relationships (Teen Connect Triple P; TCTP). We will be using an active control condition; the Blues Program is an existing cognitive behavioural program typical of those used in Australian mental health clinics for adolescents with symptoms of depression and anxiety. Both arms will be delivered by therapists enrolled in advanced post-graduate clinical psychology training under the supervision of endorsed Clinical Psychologists. The interventions will be delivered online via Zoom. Participants will be in their own homes and therapists will be located at either The University of Queensland or QIMR Berghofer.

Interventions consist of six weekly therapist-led group sessions of 1.5 hours each. Each adolescent will participate in a group with 5 other adolescents. Altogether, there will be 8 groups of TCTP and 8 groups of the Blues Program. In TCTP, parents will also participate (also in groups of 6) in parallel sessions to their teenagers. Adolescents and their parents participate in separate streams focusing on reciprocal social and emotional skills. Adolescents learn how to strengthen friendships, interpret motives of peers, address issues calmly and assertively, resolve conflicts and seek help from their parents when needed. Parents learn how to support their adolescent’s friendships, listen to their adolescent’s concerns (without over-reacting or taking over), help their adolescent interpret peer motives, coach their adolescent in managing problems, and support their adolescents in making decisions and becoming independent. In each session, therapists educate participants about effective strategies through directed group discussions, skills-building exercises (modelling and role plays) and goal-setting for personal use.

Both TCTP and The Blues Program are manualised meaning that there are set workbooks for adolescents (and parents for TCTP), prescribed activities for therapists to facilitate and set information for therapists to deliver and pre-set homework tasks for therapists to set for each session.

Regarding fidelity, research assistants will attend 33% of groups to evaluate this through protocol checklists.

The parent and teenager workbooks for the Teen Connect Triple P program have been developed for this study.
Intervention code [1] 321741 0
Treatment: Other
Intervention code [2] 321742 0
Behaviour
Comparator / control treatment
The Blues Program will be used for the active control arm. The Blues Program is an existing cognitive behavioural program, which is typical of the psych-educational intervention that adolescents with internalising problems would receive in an outpatient mental health clinic in Australia. The Blues Program will be delivered over the same period as TCTP, i.e. 6 x 1.5 hour weekly sessions. These will also be delivered via Zoom to groups of 6 adolescents.
Control group
Active

Outcomes
Primary outcome [1] 329388 0
Adolescent depression (adolescent report)
Timepoint [1] 329388 0
This will be measured at 0 and 3 months through the Patient Health Questionnaire (adolescent version) with adolescents as respondents. We will also conduct a follow-up assessment at 12 months after the initial assessment.
Primary outcome [2] 329389 0
Adolescent distress
Timepoint [2] 329389 0
Adolescent Distress will be measured at 0 and 3 months through the Kessler Psychological Distress Scale (adolescent report). We will also conduct a follow-up assessment at 12 months after the initial assessment.
Primary outcome [3] 329390 0
Bullying victimisation of adolescents by peers (adolescent report)
Timepoint [3] 329390 0
Bullying victimisation will be measured at 0 and 3 months by the Bullying and Cyberbullying Scale for Adolescents (answered by adolescents). We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [1] 401020 0
Social support of adolescent
Timepoint [1] 401020 0
Social support of adolescents will be measured at 0 months and 3 months using the Multidimensional Scale of Social Support (perceived support from family, friends, significant others), with adolescents as respondents.. We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [2] 402421 0
Facilitative parenting
Timepoint [2] 402421 0
Facilitative parenting (parenting that is supportive of children's peer relationships) will be measured at 0 months and 3 months using the Facilitative Parenting Scale, with parents as respondents.. We will also onduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [3] 402422 0
Parent-adolescent conflict (adolescent report)
Timepoint [3] 402422 0
Parent-adolescent conflict will be measured at 0 months and 3 months using the Conflict Behaviour Questionnaire (with adolescents as respondents). We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [4] 402423 0
Peer problems (adolescent report)
Timepoint [4] 402423 0
Peer problems will be measured by the Peer problems subscale of the Strengths and Difficulties questionnaire at 0 months and 3 months (with adolescents as respondents). We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [5] 402425 0
Bullying behaviour by adolescent towards peers (adolescent report)
Timepoint [5] 402425 0
Bullying behaviour by the adolescent will be measured by the Olweus Global Bullying question asked with respect to peers (with adolescents as respondents). We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [6] 402950 0
Adolescent depression (parent report)
Timepoint [6] 402950 0
This will be measured at 0 and 3 months through the Patient Health Questionnaire (adolescent version), with parents as respondents. We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [7] 402951 0
Emotional symptoms of adolescent (adolescent report)
Timepoint [7] 402951 0
Emotional symptoms will be measured at 0 and 3 months through the Emotional Problems subscale of the Strengths and Difficulties Questionnaire with adolescents as respondents. We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [8] 402952 0
Emotional symptoms of adolescent (parent report)
Timepoint [8] 402952 0
Emotional symptoms of adolescents will be measured at 0 and 3months through the Emotional Problems subscale of the Strengths and Difficulties Questionnaire (with parents) as respondents.
Secondary outcome [9] 402953 0
Global victimisation of adolescent by peers (adolescent report)
Timepoint [9] 402953 0
Global bullying victimisation will be measured at 0 and 3 months through the Olweus Global Victimisation question asked with respect to peers (reported by adolescents). We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [10] 402954 0
Global victimisation of adolescent by peers (parent report)
Timepoint [10] 402954 0
Global Bullying victimisation will be measured at 0 and 3 months through the Olweus Global Victimisation question asked with respect to peers (parent report). We will also onduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [11] 402955 0
Global victimisation of adolescent by siblings (adolescent report)
Timepoint [11] 402955 0
Global Bullying victimisation will be measured at 0 and 3 months through the Olweus Global Victimisation question asked with respect to siblings (reported by adolescents). We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [12] 402956 0
Global victimisation of adolescent by siblings (parent report)
Timepoint [12] 402956 0
Global Bullying victimisation will be measured at 0 and 3 months through the Olweus Global Victimisation question asked with respect to siblings (reported by parents. We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [13] 402957 0
Parent-adolescent conflict (parent report)
Timepoint [13] 402957 0
Parent-adolescent conflict will be measured at 0 months and 3 months using the Conflict Behaviour Questionnaire (with parents as respondents). We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [14] 402958 0
Peer problems (parent report)
Timepoint [14] 402958 0
Peer problems will be measured by the Peer problems subscale of the Strengths and Difficulties questionnaire at 0 months and 3 months (with parents as respondents). We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [15] 402959 0
Bullying behaviour by adolescent towards peers (parent report)
Timepoint [15] 402959 0
Bullying behaviour by the adolescent towards peers will be measured by the Olweus Global Bullying question asked with respect to peers (with parents as respondents). We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [16] 402960 0
Bullying behaviour by adolescent towards siblings (adolescent report)
Timepoint [16] 402960 0
Bullying behaviour by the adolescent towards siblings will be measured by the Olweus Global Bullying question asked with respect to peers (with adolescents as respondents). We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [17] 402961 0
Bullying behaviour by adolescent towards siblings (parent report)
Timepoint [17] 402961 0
Bullying behaviour by the adolescent towards siblings will be measured by the Olweus Global Bullying question asked with respect to siblings (with parents as respondents). We will also conduct a follow-up assessment at 12 months after the initial assessment.
Secondary outcome [18] 402962 0
Parent distress
Timepoint [18] 402962 0
Parent Distress will be measured at 0 and 3 months through the Kessler Psychological Distress Scale (parent report). We will also conduct a follow-up assessment at 12 months after the initial assessment.

Eligibility
Key inclusion criteria
To be eligible to participate in this study. The family must meet all of the following criteria:
(1) An adolescent/child enrolled in an Australian school in Years 7-12 (ages 11-19 years)
(2) In the initial screening interview, the parent’s score is in the elevated (borderline) range for both the Peer Problems (i.e. a score of 3/10 or higher) and the Emotional problems subscale (i.e. a score of 4/10 or higher) of the Strengths and Difficulties Questionnaire (a standard screening instrument)
(3) The parent reports they have access to the minimal technology (a phone or computer with a camera and microphone and reliable internet access), that will allow participation in online sessions through Zoom.
Minimum age
11 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include:
(1) Adolescents who attend special schools (and are therefore likely to have developmental delays affecting language),
(2) Families that report other barriers to parental and adolescent participation in an online program such as insufficient English language, a severe visual or hearing impairment that will impede full participation in sessions, and
(3) Either an answer of “yes” to both questions about adolescent suicidality either in the initial parent interview or the initial online adolescent questionnaire OR a determination that the adolescent is actively suicidal (currently considered or intended plan of action) during their follow-up phone-call if the adolescent answered “yes” to one of the suicidality screeners in the online questionnaire.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Statisticians will request a random binary number sequence from a colleague not associated with the project. Participants will only be randomised to a treatment after they have been deemed eligible to take part in the study. The psychologists completing the screening and eligibility criteria testing will not be involved in the randomisation procedure. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence will include 104 numbers that are either “1’s” (designating the TCTP condition) or “2’s” (designating the Blues program condition). We will request block randomisation for each group of 20 numbers to ensure a roughly equal allocation to each condition throughout recruitment. As program will be conducted with groups of six families, block randomisation will help ensure that families do not have to wait too long for a suitable group to start.
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
For this pilot RCT, a sample size of at least 70 families is required for reliable estimation of parameters for a full RCT. Allowing for possible attrition of up to 20%, we aim to recruit at least 84 families. Data will be analysed on an intention-to-treat basis with missing data handled through multiple imputations. We will use linear mixed-effects models for repeated measures (with measurements nested within individuals) to compare change in time over the two treatment arms; this will inform calculation of the sample size required for the full RCT. Any deviation(s) from this original statistical plan will be described and justified in the final report.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/11/2021
Actual
2/02/2021
Date of last participant enrolment
Anticipated
28/02/2022
Actual
20/06/2022
Date of last data collection
Anticipated
30/08/2023
Actual
27/08/2023
Sample size
Target
96
Accrual to date
Final
95
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309694 0
Other
Name [1] 309694 0
QIMR Berghofer Seed Funding Grant
Country [1] 309694 0
Australia
Primary sponsor type
Other
Name
QIMR Berghofer Medical Research Institute
Address
300 Herston Road
Herston, Qld, 4006
Australia
Country
Australia
Secondary sponsor category [1] 310719 0
None
Name [1] 310719 0
Address [1] 310719 0
Country [1] 310719 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309463 0
QIMR Berghofer Medical Research Institute Human Research Ethics Committee
Ethics committee address [1] 309463 0
Ethics committee country [1] 309463 0
Australia
Date submitted for ethics approval [1] 309463 0
21/09/2021
Approval date [1] 309463 0
02/11/2021
Ethics approval number [1] 309463 0
P3545
Ethics committee name [2] 309835 0
The University of Queensland Research Ethics and Integrity
Ethics committee address [2] 309835 0
Ethics committee country [2] 309835 0
Australia
Date submitted for ethics approval [2] 309835 0
11/11/2021
Approval date [2] 309835 0
12/11/2021
Ethics approval number [2] 309835 0
2021/HE002552

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

Contacts
Principal investigator
Name 114242 0
Dr Karyn Healy
Address 114242 0
QIMR Berghofer Medical Research Institute
300 Herston Road
Herston, Qld, Australia
4006
Country 114242 0
Australia
Phone 114242 0
+617 3361 0186
Fax 114242 0
Email 114242 0
[email protected]
Contact person for public queries
Name 114243 0
Karyn Healy
Address 114243 0
QIMR Berghofer Medical Research Institute
300 Herston Road
Herston, Qld, Australia
4006
Country 114243 0
Australia
Phone 114243 0
+617 3361 0186
Fax 114243 0
Email 114243 0
[email protected]
Contact person for scientific queries
Name 114244 0
Karyn Healy
Address 114244 0
QIMR Berghofer Medical Research Institute
300 Herston Road
Herston, Qld, Australia
4006
Country 114244 0
Australia
Phone 114244 0
+617 3361 0186
Fax 114244 0
Email 114244 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?
De-dentified data may be shared to other researchers for purposes of inclusion in meta-analysese
When will data be available (start and end dates)?
2023-2040
Available to whom?
Other researchers conducting meta-analyses
Available for what types of analyses?
Inclusion of this study in meta-analyses
How or where can data be obtained?
Contacting the investigator [email protected]


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
No additional documents have been identified.