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Trial registered on ANZCTR


Registration number
ACTRN12614000297628
Ethics application status
Approved
Date submitted
6/03/2014
Date registered
20/03/2014
Date last updated
1/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment Approaches for Children and Young people in Child and Adolescent Mental Health Services (CAMHS) Study: Comparing the Modular Approach to Therapy for Children (MATCH-ADTC) with usual care in improving clinical outcomes of children and adolescents with depression, anxiety, trauma or conduct problems
Scientific title
In children and adolescents (aged 7-14) attending Child and Adolescent Mental Health Services (CAMHS) for depression, anxiety, trauma or conduct problems does the Modular Approach to Therapy for Children (MATCH-ADTC), compared to usual care, improve clinical outcomes (measured by comparing difference in trajectory of change of clinical severity)?
Secondary ID [1] 284213 0
Nil known
Universal Trial Number (UTN)
U1111-1154-1934
Trial acronym
The TrACY study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 291319 0
Anxiety
 291320 0
Trauma symptoms 291321 0
Conduct problems 291322 0
Condition category
Condition code
Mental Health 291676 291676 0 0
Depression
Mental Health 291677 291677 0 0
Anxiety
Mental Health 291678 291678 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MATCH (intervention) consists of a manual and a training package (i.e. five days of block training and a year of weekly telephone/Skype consultation sessions (60 minutes in duration) from a MATCH trainer to support clinicians in the use of MATCH). MATCH was specifically designed to combine the effective elements of the evidence based therapies (EBTs) for anxiety, depression, trauma-related symptoms and disruptive behaviour in one protocol, cater for co-morbidity and provide an opportunity to address different disorders that may emerge during therapy.
MATCH is comprised of 33 modules/specific treatment procedures which can be organised in a flexible manner. Children/adolescents and their families are also given an integral role in defining the goals of therapy. Clinicians use a web-based system (specifically developed for this study) to monitor progress and adapt therapy in consultation with a child/adolescent and their family until a problem is resolved.
MATCH provides flexibility for the clinician to use a selection of modules depending on the needs of the child and his/her family. To guide the selection of modules, clinicians monitor progress and use MATCH flowcharts to identify which modules are required. All sessions are done face-to-face and are one-on-one with the child or his/her family. There is no standard duration of treatment. Sessions typically last between 45 and 60 minutes and are usually weekly (depending on the individual clinic and the child/family's circumstances). Not all modules need to be administered for every child/family.
To monitor adherence to the treatment protocol, all sessions will be audio-recorded and a sample of these recordings will be coded to ascertain the content. Clinicians will also be required to keep a log of their therapy sessions and treatment approaches (use of modules) will be discussed in weekly Skype supervision.
Intervention code [1] 288914 0
Treatment: Other
Comparator / control treatment
Usual care/UC group: Usual care will be the treatment that is usually provided to a child/adolescent at a Child and Adolescent Mental Health Services (CAMHS) (e.g. case management, therapeutic group work and psychotherapy).
Control group
Active

Outcomes
Primary outcome [1] 291620 0
The primary clinical outcome measure will be the Brief Problem Monitor (BPM). BPM will be collected weekly via telephone.
Timepoint [1] 291620 0
On a weekly basis until therapy is completed.
Primary outcome [2] 291621 0
The primary outcome measure of the delivery of evidence based therapy will be made via coding of audio taped therapy sessions. All MATCH and UC therapy sessions will be audiotaped. A randomly selected subset approximately 5-10 % (both MATCH and UC) will be assessed by the research team (blind to treatment allocation) for EBT content using the methods and the coding system developed for the initial trial of MATCH
Timepoint [2] 291621 0
Coding of randomly selected therapy sessions will be done throughout the study until all data is collected. As we are coding only a random selection of recorded sessions, there will not be a regular interval on which the frequency of coding is based.
Primary outcome [3] 291622 0
The primary outcome measure of the efficiency of services will be made through a comparisons between MATCH and UC for the following:
1) Total therapy input by clinicians (in minutes) (using a self-report therapy log collected weekly)
2) contact with the CAMHS (in weeks), (using a self-report therapy log collected weekly)
3) number of therapy sessions and (using a self-report therapy log collected weekly)
4) number of missed therapy sessions (using a self-report therapy log collected weekly).
Timepoint [3] 291622 0
Post intervention - This will vary according to treatment duration for each individual participant.
Secondary outcome [1] 307173 0
The Strengths and Difficulties Questionnaire (SDQ)
Timepoint [1] 307173 0
SDQ will be collected monthly
Secondary outcome [2] 307174 0
The Top Problems Assessment (TPA)
Timepoint [2] 307174 0
TPA will be collected weekly
Secondary outcome [3] 307175 0
The Development and Well-Being Assessment (DAWBA)
Timepoint [3] 307175 0
DAWBA will be collected at baseline and post-intervention
Secondary outcome [4] 307176 0
Child Health Utility (CHU9D)
Timepoint [4] 307176 0
CHU9D will be collected at baseline, post intervention and at 3 month follow up

Eligibility
Key inclusion criteria
Children and adolescents will be eligible for inclusion in the trial if:
1) They are newly referred to a participating CAMHS with a primary disorder that includes anxiety, depression, trauma-related symptoms or disruptive behaviour;
2) They are 7 to 14 years of age on the date of consent;
3) They are able to provide written consent (or verbal assent) and have written parental/guardian consent; and,
4) The child and their parent/guardian can speak English or there is a clinician who can provide the necessary treatment, according to the treatment arm the participant is randomised to, in the family’s native language.
Minimum age
7 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children and adolescent will be ineligible for inclusion in the trial if:
1) They are currently receiving other treatment for their disorder from the CAMHS (or another service); or,
2) They do not have a primary disorder of psychosis, severe intellectual disability, attention deficit-hyperactivity disorder (where the primary reason for referral is inattention and/or over-activity), autism or other pervasive developmental disorder, anorexia nervosa or bulimia nervosa;
3) The young person is acutely suicidal; or,
4) They have a sibling that has previously been recruited into 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)
Recruitment will be via CAMHS clinicians. Eligible participants will be invited to participate by a clinician whom they have met during their standard initial assessment (or intake assessment).
Child and adolescent participants and their parents/caregivers will be given written information sheets and consent forms. Written consent will be collected from all parents/caregivers. Written consent (or verbal assent for younger participants) will be collected from all child or adolescent participants.
Once consent is collected, the clinician will enter the participant's details into a custom-made online tracking system which will generate the treatment allocation. This will be emailed to the clinic's administrator. The child/adolescent will be allocated a clinician according to treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of child and adolescent participants: After the eligibility check, and once consent/assent and collection of baseline assessments have been completed, participants will be randomised in a 1:1 ratio to receive MATCH or UC stratified by sex and ethnicity.

Allocation concealment will be assured by using centralised computer generation of the randomisation sequence.

We will use web-based randomisation procedures to determine treatment allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Randomisation occurs on two levels:

1) Randomisation of clinicians: All clinicians from participating CAMHS teams will be invited to participate. Consenting CAMHS clinicians will be block randomised (by service/team) in a 1:1 ratio to MATCH or UC. The block size will vary across sites depending upon the number of individuals likely to be recruited from each site. Clinicians will be stratified on the basis of previous evidence-based therapy training (i.e. those with versus those without accredited training in cognitive behavioural therapy or behavioural parent training).

2) Randomisation of children/adolescents
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses: We will assess the comparability of baseline of both treatment groups (i.e. MATCH and UC) using descriptive analyses, in terms of age, sex, symptom severity, diagnosis and ethnicity. Both treatments may vary in content and duration, so that pre-post and follow-up (three months after treatment has ended) analyses are potentially confounded by treatment duration and/or dose. To deal with this, we propose to use the trajectories of change across time on the d BPM as our primary outcome measure. We will carry out per-protocol analyses and intention to treat analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/03/2014
Actual
Date of last participant enrolment
Anticipated
30/10/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 5868 0
New Zealand
State/province [1] 5868 0

Funding & Sponsors
Funding source category [1] 288838 0
Government body
Name [1] 288838 0
Health Research Council (HRC)
Country [1] 288838 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council (HRC)
Address
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland 1010, New Zealand
Country
New Zealand
Secondary sponsor category [1] 287532 0
None
Name [1] 287532 0
Address [1] 287532 0
Country [1] 287532 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290678 0
Health And Disability Ethics Committees
Ethics committee address [1] 290678 0
Ethics committee country [1] 290678 0
New Zealand
Date submitted for ethics approval [1] 290678 0
Approval date [1] 290678 0
02/09/2013
Ethics approval number [1] 290678 0
13/CEN/97

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

Contacts
Principal investigator
Name 46742 0
A/Prof Sally Merry
Address 46742 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
Country 46742 0
New Zealand
Phone 46742 0
649 3737599
Fax 46742 0
Email 46742 0
s.merry@auckland.ac.nz
Contact person for public queries
Name 46743 0
Sarah Hopkins
Address 46743 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
Country 46743 0
New Zealand
Phone 46743 0
649 3737599 ext 82015
Fax 46743 0
Email 46743 0
s.hopkins@auckland.ac.nz
Contact person for scientific queries
Name 46744 0
Sarah Hopkins
Address 46744 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
Country 46744 0
New Zealand
Phone 46744 0
649 3737599 ext 82015
Fax 46744 0
Email 46744 0
s.hopkins@auckland.ac.nz

No information has been provided regarding IPD availability


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
EmbaseModular Approach to Therapy for Anxiety, Depression, Trauma, or Conduct Problems in outpatient child and adolescent mental health services in New Zealand: Study protocol for a randomized controlled trial.2015https://dx.doi.org/10.1186/s13063-015-0982-9
N.B. These documents automatically identified may not have been verified by the study sponsor.