ANZCTR - Registration

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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

Condition category

Condition code

Mental Health

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]

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]

Clinically significant decrease in Reynold's Adolescent Depression Scale (RADS-2)

Timepoint [1]

Recorded 12 weeks and 24 weeks after start of treatment.

Secondary outcome [1]

Group differences in treatment satisfaction scores.

Timepoint [1]

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?

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

Accrual to date

Final

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

beyondblue

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr. Cate Bearsley-Smith

Address

Country

Secondary sponsor category [1]

Individual

Name [1]

Prof. Mark Oakley Browne

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Uni.

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

27/04/2007

Ethics approval number [1]

2007/0075MC

Ethics committee name [2]

Latrobe Regional Hospital.

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

23/05/2007

Ethics approval number [2]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Cate Bearsley-Smith

Address

C/O School of Rural Health
Latrobe Regional Hospital
Princes Hwy
PO Box 424
TRARALGON
VIC3844

Country

Australia

Phone

+6 13 5173 8181

Fax

+6 13 5173 8182

cate.bearsley-smith@med.monash.edu.au

Contact person for scientific queries

Name

Dr. Cate Bearsley-Smith

Address

C/O School of Rural Health
Latrobe Regional Hospital
Princes Hwy
PO Box 424
Traralgon VIC 3844

Country

Australia

Phone

+6 13 5173 8181

Fax

+6 13 5173 8182

cate.bearsley-smith@med.monash.edu.au

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.

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