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Trial registered on ANZCTR


Registration number
ACTRN12617001445369
Ethics application status
Approved
Date submitted
5/10/2017
Date registered
11/10/2017
Date last updated
26/03/2019
Date data sharing statement initially provided
26/03/2019
Date results information initially provided
26/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a psychological intervention reduce irritability in children?
Scientific title
Can a psychological intervention improve mood regulation and reduce irritability in children? Pilot for large-scale RCT
Secondary ID [1] 293062 0
Nil
Universal Trial Number (UTN)
U1111-1203-2008
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritability 304992 0
Condition category
Condition code
Mental Health 304315 304315 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 trained child psychiatrists or psychologists within a Child & Adolescent Mental Health Service. The intervention comprises 6x1 hour sessions once a week for six weeks (total of 6 sessions).
The intervention is administered face-to-face 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.
Intervention code [1] 299305 0
Treatment: Other
Comparator / control treatment
Treatment as usual.
All participants are recruited through a Child and Adolescent Mental Health Service (CAMHS), Participants assigned to treatment as usual will be treated as any other patient with a referral to a CAMHS. 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] 303584 0
Feasibility of the intervention measured through intake into the study and attendance of intervention sessions.
Timepoint [1] 303584 0
3 months post-randomisation
Primary outcome [2] 303619 0
Acceptability of the intervention measured through study-designed questions (composite of parent and child responses) assessing the usefulness of program strategies and ability to put strategies into practice.
Timepoint [2] 303619 0
3 months post-randomisation
Secondary outcome [1] 339467 0
Child irritability measured by the parent reported Affective Reactivity Index
Timepoint [1] 339467 0
Baseline and 3 months post-randomisation
Secondary outcome [2] 339483 0
Child quality of life measured by the parent reported PedsQL
Timepoint [2] 339483 0
Baseline and 3 months post-randomisation
Secondary outcome [3] 339484 0
Child executive functioning measured by the parent reported Behaviour Rating Inventory of Executive Functioning
Timepoint [3] 339484 0
Baseline and 3 months post-randomisation
Secondary outcome [4] 339485 0
Child depressive symptoms measured by the Short Moods & Feelings Questionnaire (parent report).
Timepoint [4] 339485 0
Baseline and 3 months post-randomisation
Secondary outcome [5] 339486 0
ADHD symptoms measured by the parent reported SNAP-IV
Timepoint [5] 339486 0
Baseline and 3 months post-randomisation
Secondary outcome [6] 339487 0
ODD symptoms measured by the SNAP-IV (parent report).
Timepoint [6] 339487 0
Baseline and 3 months post-randomisation
Secondary outcome [7] 339488 0
Anxiety measured by the Spence Child Anxiety Scale (parent report).
Timepoint [7] 339488 0
Baseline and 3 months post-randomisation
Secondary outcome [8] 339489 0
Parent irritability measured by the Affective Reactivity Index (parent self report).
Timepoint [8] 339489 0
Baseline and 3 months post-randomisation
Secondary outcome [9] 339490 0
Parent mental health measured by the Kessler-6 (parent self report).
Timepoint [9] 339490 0
Baseline and 3 months post-randomisation
Secondary outcome [10] 339491 0
Family functioning measured by the McMaster Family Assessment Device (parent report).
Timepoint [10] 339491 0
Baseline and 3 months post-randomisation
Secondary outcome [11] 339492 0
Parent report of school attendance over the previous 3 months.
Timepoint [11] 339492 0
Baseline and 3 months post-randomisation
Secondary outcome [12] 339493 0
Self-reported parent work attendance over the previous 3 months.
Timepoint [12] 339493 0
Baseline and 3 months post-randomisation
Secondary outcome [13] 339649 0
Child irritability measured by the child reported Affective Reactivity Index
Timepoint [13] 339649 0
Baseline and 3 months post-randomisation
Secondary outcome [14] 339650 0
Child irritability measured by the clinician reported Affective Reactivity Index
Timepoint [14] 339650 0
Baseline and 3 months post-randomisation
Secondary outcome [15] 339651 0
Child quality of life measured by the child reported PedsQL
Timepoint [15] 339651 0
Baseline and 3 months post-randomisation

Eligibility
Key inclusion criteria
Children aged 6-15 years referred to a Child and Adolescent Mental Health Service with a score of 4 or higher on the parent rated Affective Reactivity Index.
Minimum age
6 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), a depressive disorder or considered to be 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 age (5-11 or 12-15) to ensure similar proportions of 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
Given this is a pilot study, existing literature was used as a guide to determine the desired sample size. A sample size of 30 families will enable us to determine if the approach is useful, acceptable to parents and children and feasible to deliver in a clinical setting. As such formal power calculations were not required.
Sample characteristics will be described together with caregiver report of each component’s acceptability, frequency of use and ease of use. Barriers to consultation attendance and uptake of intervention strategies will be presented. Although not a trial designed to determine efficacy of the intervention, mean differences (baseline-3 months) in child and family outcomes will be reported and will provide important data to calculate sample size and power for the main study. We will complete per protocol analyses for the secondary outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2017
Actual
28/02/2018
Date of last participant enrolment
Anticipated
30/06/2018
Actual
16/05/2018
Date of last data collection
Anticipated
30/09/2018
Actual
13/09/2018
Sample size
Target
30
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9160 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 17673 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 297685 0
Other
Name [1] 297685 0
Murdoch Children's Research Institute
Country [1] 297685 0
Australia
Primary sponsor type
Individual
Name
Melissa Mulraney
Address
Community Health Services Research
Murdoch Children's Research Institute
50 Flemington Rd
Parkville 3052
Country
Australia
Secondary sponsor category [1] 296709 0
None
Name [1] 296709 0
Address [1] 296709 0
Country [1] 296709 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298757 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 298757 0
The Royal Children's Hospital
50 Flemington Rd
Parkville VIC 3052
Ethics committee country [1] 298757 0
Australia
Date submitted for ethics approval [1] 298757 0
Approval date [1] 298757 0
25/08/2017
Ethics approval number [1] 298757 0
37145

Summary
Brief summary
Approximately 30% of patients referred to the outpatient Mental Health service at The Royal Children’s Hospital present with significant and impairing irritability, aggression and mood dysregulation. Irritability and mood dysregulation are defined as a proneness to anger that is out of proportion to the situation and which often leads to verbally or physically aggressive outbursts. Children who are highly irritable have been found to have poorer quality of life, daily functioning, and social functioning, and are at very high risk of developing multiple psychiatric disorders. Currently however, there are no evidence based treatments for irritability. As such this study aims to assess the feasibility and acceptability of a behavioural treatment program in children (aged 6-15 years) referred to the RCH outpatient mental health service with severe irritability, and to explore the impact on child and family outcomes. Participants will be randomised into usual care (n=15) or a 6 session intervention (n=15). The intervention consists of six hour-long weekly sessions. All participants will be assessed three months post-randomisation to assess preliminary outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78130 0
Dr Melissa Mulraney
Address 78130 0
Community Health Services Research
Murdoch Children's Research Institute
50 Flemington Rd
Parkville VIC 3052
Country 78130 0
Australia
Phone 78130 0
+61 03 99366628
Fax 78130 0
Email 78130 0
[email protected]
Contact person for public queries
Name 78131 0
Dr Melissa Mulraney
Address 78131 0
Community Health Services Research
Murdoch Children's Research Institute
50 Flemington Rd
Parkville VIC 3052
Country 78131 0
Australia
Phone 78131 0
+61 03 99366628
Fax 78131 0
Email 78131 0
[email protected]
Contact person for scientific queries
Name 78132 0
Dr Melissa Mulraney
Address 78132 0
Community Health Services Research
Murdoch Children's Research Institute
50 Flemington Rd
Parkville VIC 3052
Country 78132 0
Australia
Phone 78132 0
+61 03 99366628
Fax 78132 0
Email 78132 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
We did not obtain participant consent for data-sharing.


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.