Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000324415
Ethics application status
Approved
Date submitted
12/06/2007
Date registered
18/06/2007
Date last updated
18/06/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Interpersonal Psychotherapy improve clinical care for adolescents with depression attending a rural child and adolescent mental health service? A feasibility study
Scientific title
Amongst depressed adolescents attending a rural Child and Adolescent Mental Health Service, does Interpersonal Psychotherapy, compared to Treatment as Usual, improve clinical care? An implementation feasibility study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive symptomatology amongst adolescents 1873 0
Condition category
Condition code
Mental Health 1967 1967 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention
Half the participating clinicians will be randomised to receive training and supervision in Interpersonal Psychotherapy (IPT). This treatment stream will comprise IPT plus any/all relevant elements of usual CAMHS care (e.g. liaison with school; family support; medication) deemed relevant by the treating clinician or team. These elements will be recorded. IPT treatment will comprise sessions of manual-based IPT over 12 weeks with the adolescent (and family member where relevant). Maintenance IPT will be continued for up to a further 12 weeks.
Intervention code [1] 1664 0
Treatment: Other
Comparator / control treatment
Control treatment
The remaining clinicians will provide their usual care (i.e. Treatment as Usual) for the client and records the content and frequency of sessions.
Control group
Active

Outcomes
Primary outcome [1] 2781 0
Clinically significant decrease in Reynold's Adolescent Depression Scale (RADS-2)
Timepoint [1] 2781 0
Recorded 12 weeks and 24 weeks after start of treatment.
Secondary outcome [1] 4695 0
Group differences in treatment satisfaction scores.
Timepoint [1] 4695 0
Recorded 12 weeks and 24 weeks after start of treatment

Eligibility
Key inclusion criteria
Adolescent participants have significant depressive symptoms (Reynold’s Adolescent Depression Scale >clinical cut-off of T=61) or a DSM-IV diagnosis of a depressive disorder (i.e. Major Depressive Disorder (MDD), Dysthymic Disorder, Depressive Disorder NOS, or Adjustment Disorder with Depressed Mood) and a CGAS of 65 or lower. Adolescents will not be included if they are actively suicidal, have a life-threatening condition, psychosis or schizophrenia. Parents/guardian’s will be eligible to participate if their adolescent is participating in the study. They will comprise primary caregivers as identified by the participating adolescents. Up to two carers will be invited to participate for each adolescent.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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 of clinicians (the unit of randomisation) to IPT or TAU was accomplished centrally. The Study Coordinator, who had no knowledge of the allocation sequence, contacted the Study Biostatistician, who resided off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation stratified by study centre.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Cluster
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2107 0
Charities/Societies/Foundations
Name [1] 2107 0
beyondblue
Country [1] 2107 0
Australia
Primary sponsor type
Individual
Name
Dr. Cate Bearsley-Smith
Address
Country
Secondary sponsor category [1] 1914 0
Individual
Name [1] 1914 0
Prof. Mark Oakley Browne
Address [1] 1914 0
Country [1] 1914 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3898 0
Monash Uni.
Ethics committee address [1] 3898 0
Ethics committee country [1] 3898 0
Australia
Date submitted for ethics approval [1] 3898 0
Approval date [1] 3898 0
27/04/2007
Ethics approval number [1] 3898 0
2007/0075MC
Ethics committee name [2] 3899 0
Latrobe Regional Hospital.
Ethics committee address [2] 3899 0
Ethics committee country [2] 3899 0
Australia
Date submitted for ethics approval [2] 3899 0
Approval date [2] 3899 0
23/05/2007
Ethics approval number [2] 3899 0
2006-06

Summary
Brief summary
Adolescent depression is a costly problem for our communities, families and young people. Currently, when detected, treatment provided for depression within Australian Child and Adolescent Mental Health Services (CAMHS) is of unknown content and effectiveness.

The objectives of the clinical research are:
1. to investigate the impact on clinical care of implementing Interpersonal Psychotherapy for Adolescents (IPT-A) for the treatment of adolescent depression within a rural CAMHS compared with Treatment as Usual (TAU).
2. to evaluate the issues associated with implementing a clinical trial in CAMHS (i.e. feasibility, acceptability, sustainability).

Half the participating clinicians will receive IPT-A training and supervision, with the remaining clinicians providing their usual care (i.e. Treatment as Usual). Treatment as Usual (TAU) for adolescent depression in CAMHS is anticipated to vary in content and frequency according to who is providing it. One outcome of the project will be the clarification of what TAU comprises within the rural CAMHS. Eligible and consenting therapists will be randomized to either stream (within each site) where possible. Implementation issues will be investigated qualitatively using focus groups with clinicians and interviews with clients, carers and clinicians.

The research will be conducted within the Latrobe Regional Hospital (LRH) CAMHS in Gippsland. All clinicians, employed full- or part-time within the LRH CAMHS, will be invited to participate. The trial aims to include a minimum of 60 adolescent clients of LRH CAMHS, aged 12 to 18 years, recruited over two years. Adolescents will be eligible to participate if they have significant depressive symptoms (exceeding Reynold’s Adolescent Depression Scale clinical cutoff) or a DSM-IV diagnosis of a depressive disorder (i.e. Major Depressive Disorder (MDD), Dysthymic Disorder, Depressive Disorder Not Otherwise Specified (NOS), or Adjustment Disorder with Depressed Mood) and a Children’s Global Assessment Scale (CGAS) of 65 or lower. All eligible clients will need parental consent and the agreement of the CAMHS consultant psychiatrist, regarding diagnosis and client suitability, to participate.

Monitoring and outcome assessment will use the usual CAMHS outcome measures as well as some additional reliable and valid measures applied in similar research. They will include adolescent self-report, parent-report and clinician ratings. Treatment groups will be compared for demographic characteristics, diagnosis, measures of clinical improvement and treatment acceptability. Themes from focus group and interview data will be detected in qualitative analysis of transcripts using the constant comparative cyclic analysis method.

The project is expected to increase understanding of the issues and outcomes associated with implementing and evaluating an evidence-based intervention for adolescent depression in a rural child and adolescent mental health service.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27767 0
Address 27767 0
Country 27767 0
Phone 27767 0
Fax 27767 0
Email 27767 0
Contact person for public queries
Name 10853 0
Dr. Cate Bearsley-Smith
Address 10853 0
C/O School of Rural Health
Latrobe Regional Hospital
Princes Hwy
PO Box 424
TRARALGON
VIC3844
Country 10853 0
Australia
Phone 10853 0
+6 13 5173 8181
Fax 10853 0
+6 13 5173 8182
Email 10853 0
[email protected]
Contact person for scientific queries
Name 1781 0
Dr. Cate Bearsley-Smith
Address 1781 0
C/O School of Rural Health
Latrobe Regional Hospital
Princes Hwy
PO Box 424
Traralgon VIC 3844
Country 1781 0
Australia
Phone 1781 0
+6 13 5173 8181
Fax 1781 0
+6 13 5173 8182
Email 1781 0
[email protected]

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
No additional documents have been identified.