Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001027808
Ethics application status
Approved
Date submitted
16/07/2021
Date registered
5/08/2021
Date last updated
21/01/2022
Date data sharing statement initially provided
5/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Collaborative and Proactive Solutions for irritability in children and adolescents
Scientific title
Can a psychological intervention reduce irritability in children and adolescents more than usual care? A randomised-controlled trial
Secondary ID [1] 304804 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is the fully powered RCT informed by the pilot study ACTRN12617001445369.

Health condition
Health condition(s) or problem(s) studied:
Irritability 322867 0
Condition category
Condition code
Mental Health 320448 320448 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a psychological therapy called Collaborative & Proactive Solutions. It will be delivered by study trained clinicians. The intervention comprises 8x1 hour sessions once a week for six weeks and then once every two weeks for the final 2 sessions (total of 8 sessions over 10 weeks).
The intervention is administered face-to-face, or via telehealth, with the child and parent/s. Sessions can include time with the parent/s alone, with the child alone, and with both the child and parent/s present. The structure of the intervention is as follows:
(a) Identification of lagging skills and unsolved problems that contribute to temper outbursts, and a discussion of how existing parental responses may be counterproductive;
(b) Prioritization—helping parents prioritize which unsolved problems will be the focal point of initial problem-solving discussions;
(c) Introduction of the Plans framework— helping parents understand the three potential responses to solving problems: Plan A (solving a problem unilaterally, through imposition of adult will and often accompanied by adult-imposed consequences), Plan B (solving a problem collaboratively and proactively), and Plan C (setting aside the problem for now); and
(d) Implementing Plan B—helping parents and children become proficient in the use of Plan B and largely discontinuing the use of Plan A.
Although the clinician actively guides the problem-solving process initially, the goal of treatment is to help the child and parents become increasingly independent in solving problems together.
Clinicians will complete a Clinical Record Form (CRF) for each session to document adherence to intervention protocols.
Intervention code [1] 321176 0
Treatment: Other
Comparator / control treatment
Treatment as usual.
Participants are recruited through outpatient and community mental health services, Participants assigned to treatment as usual will be treated as any other patient with a referral to one of these services. This will include an initial comprehensive assessment and treatment of the child's presenting problem which may include multi-modal treatments, individual, family and group therapy and parent or carer support.
Control group
Active

Outcomes
Primary outcome [1] 328282 0
Change in irritability as measured by the Clinician Rated Affective Reactivity Index (CL-ARI)
Timepoint [1] 328282 0
4-months post-randomisation
Secondary outcome [1] 398350 0
Change in irritability as measured by the Clinician Rated Affective Reactivity Index
Timepoint [1] 398350 0
12 months post-randomisation
Secondary outcome [2] 398351 0
Change in irritability as measured by the parent reported Affective Reactivity Index
Timepoint [2] 398351 0
4 and 12 months post-randomisation
Secondary outcome [3] 398352 0
Change in irritability as measured by the self-reported Affective Reactivity Index
Timepoint [3] 398352 0
4 and 12 months post-randomisation
Secondary outcome [4] 398353 0
Change in irritability as measured by the teacher reported Affective Reactivity Index
Timepoint [4] 398353 0
4 and 12 months post-randomisation
Secondary outcome [5] 398354 0
Child mental health measured by the Child Behavior Checklist
Timepoint [5] 398354 0
4 and 12 months post-randomisation
Secondary outcome [6] 398355 0
Child quality of life measured by the CHU-9D
Timepoint [6] 398355 0
4 and 12 months post-randomisation
Secondary outcome [7] 398356 0
Parent psychological distress measured by the K6
Timepoint [7] 398356 0
4 and 12 months post-randomisation
Secondary outcome [8] 398357 0
Family functioning measured by the McMaster Family Assessment Device
Timepoint [8] 398357 0
4 and 12 months post-randomisation

Eligibility
Key inclusion criteria
Children aged 5-15 years with a score of 3 or higher on the parent rated Affective Reactivity Index.
Minimum age
5 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Major illness or disability (e.g., intellectual disability)
- Non-English speaking
- Children with a psychotic disorder (e.g. schizophrenia or bipolar disorder), at risk of self-harm will be excluded from the study

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)
Allocation will be concealed. An independent statistician will pre-generate a random number sequence which contains the randomisation sequence number and the group allocated (control vs intervention), and upload it to the study database which will assign participants once they are enrolled in the database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule will be generated using block randomisation with variable block sizes by an independent statistician at the Clinical Epidemiology and Biostatistics Unit at the Murdoch Childrens Research Institute. Randomisation will be stratified by sex and age (5-11 or 12-15) to ensure similar proportions of males and females, and children and adolescents across arms
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In our pilot study, we found an effect size of 0.5 between the CPS and usual care groups. In order to provide 80% power to detect this clinically meaningful difference, using a two-sided test with alpha = 0.05, we need to enrol 64 children in each arm. Given there is typically a dropout rate of approximately 20% in trials such as this we will inflate our sample size to account for this, thus we aim to recruit a total of 160 children (80 children in each group).

Analyses will be conducted according to the intention-to-treat principle with participants analysed according to the intervention they were allocated to irrespective of what or how much intervention was received. If there is <5% missing data in the primary and key secondary outcomes, analysis will be conducted using a complete case analysis. If there is more missing data, the missingness will be explored, and if there is evidence that the data are missing at random then analysis will be conducted using multiple imputation to handle the missing data. The primary outcome, reduction of irritability on the CL-ARI, will be compared between the groups using mixed effects linear regression adjusted for sex and age (6-11 versus 12+ years) as used in randomisation. Results will be reported as an (adjusted) mean difference, 95% confidence interval and the corresponding p-value. Secondary outcomes will be compared between the groups using mixed effects linear (continuous outcomes) and logistic (binary outcomes) regression adjusted for sex and age, with results reported as (adjusted) mean differences and odds ratios, respectively, along with 95% confidence intervals and the corresponding p-values.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/08/2021
Actual
19/10/2021
Date of last participant enrolment
Anticipated
16/08/2023
Actual
Date of last data collection
Anticipated
16/08/2024
Actual
Sample size
Target
160
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19988 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 34696 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 309174 0
Charities/Societies/Foundations
Name [1] 309174 0
The Royal Children's Hospital Foundation
Country [1] 309174 0
Australia
Funding source category [2] 309177 0
University
Name [2] 309177 0
Institute for Social Neuroscience
Country [2] 309177 0
Australia
Primary sponsor type
Individual
Name
Melissa Mulraney
Address
Institute for Social Neuroscience
443 Upper Heidelberg Rd
Ivanhoe, VIC 3079
Country
Australia
Secondary sponsor category [1] 310136 0
None
Name [1] 310136 0
Address [1] 310136 0
Country [1] 310136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309034 0
Institute for Social Neuroscience Human Research Ethics Committee
Ethics committee address [1] 309034 0
Ethics committee country [1] 309034 0
Australia
Date submitted for ethics approval [1] 309034 0
01/04/2021
Approval date [1] 309034 0
10/06/2021
Ethics approval number [1] 309034 0
210401

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

Contacts
Principal investigator
Name 112726 0
Dr Melissa Mulraney
Address 112726 0
Institute for Social Neuroscience
443 Upper Heidelberg Rd
Ivanhoe, VIC, 3079
Country 112726 0
Australia
Phone 112726 0
+610390081611
Fax 112726 0
Email 112726 0
[email protected]
Contact person for public queries
Name 112727 0
Melissa Mulraney
Address 112727 0
Institute for Social Neuroscience
443 Upper Heidelberg Rd
Ivanhoe, VIC, 3079
Country 112727 0
Australia
Phone 112727 0
+610390081611
Fax 112727 0
Email 112727 0
[email protected]
Contact person for scientific queries
Name 112728 0
Melissa Mulraney
Address 112728 0
Institute for Social Neuroscience
443 Upper Heidelberg Rd
Ivanhoe, VIC, 3079
Country 112728 0
Australia
Phone 112728 0
+610390081611
Fax 112728 0
Email 112728 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 of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal 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.