Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000630213
Ethics application status
Approved
Date submitted
22/07/2009
Date registered
28/07/2009
Date last updated
27/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of enhanced cognitive therapy and family education for youth depression, anxiety, and substance abuse
Scientific title
A randomised controlled trial of enhanced cognitive therapy and family education for youth depression, anxiety, and substance abuse
Secondary ID [1] 283089 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DFO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 237315 0
Anxiety 237316 0
Condition category
Condition code
Mental Health 239638 239638 0 0
Addiction
Mental Health 239672 239672 0 0
Depression
Mental Health 239673 239673 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behavioural Exchange Systems Training (BEST) Plus - Parents receive 16 hours of parent sessions in a group with other families. Siblings are invited to join the group for the final 4 sessions of BEST Plus. The BEST Plus program will run for 8 weeks in total. The program will be administered as 1 x 2hr session per week. The BEST Plus intervention will be administered by 2 clinical facilitators: either clinical masters students or clinical staff from youth services at JIGSAW or Drummond Street Relationships Center. All facilitators will receive specialist training and supervision in the BEST Plus model.
Self Help for Alcohol/Other Drug Use and Depression for Young people (SHADEY)- The young person receives 10 individual sessions of a Cognitive Behavioural Therapy (CBT) based intervention. The program will run for a duration of 10 weeks. The SHADEY program will be administered in 1 x 90 minute sessions per week. The SHADEY program will be administered by trained clinical masters students or clinical staff from youth services at JIGSAW or Drummond Street Relationships Center. All SHADEY clinicians will receive specialist training and supervision in the SHADEY model.
Combined SHADEY and BEST Plus- Following the BEST intervention for the family, the young person is invited to complete the SHADEY intervention. The total duration of the combined condition is 18 weeks. The parents receive 8 x 2hr, weekly sessions, and siblings are invited to join their parents for the final 4 x 2hr sessions. One week following the conclusion of the BEST Plus program the young person will be invited to complete 10 x 1.5hr weekly sessions. This order of administration cannot be reversed.
Intervention code [1] 236989 0
Treatment: Other
Comparator / control treatment
3 treatments compared in Randomized Controlled Trial (RCT)
- BEST Plus
- SHADEY
- SHADEY and BEST Plus
In addition, outcomes for participants in the RCT will be compared with others who:
- Refuse to participate (receive treatment as usual)
- Are on a wait list for treatment
however these conditions are not randomly assigned.
Control group
Active

Outcomes
Primary outcome [1] 238422 0
Mean Revised Hamilton Depression Rating Scale score
Timepoint [1] 238422 0
At baseline, completion of intervention and 6 months after intervention completion by young person
Primary outcome [2] 238423 0
Mean Beck Scale for Suicidal Ideation score
Timepoint [2] 238423 0
At baseline, completion of intervention and 6 months after intervention completion by young person
Primary outcome [3] 290330 0
Mean Youth Self Report/Adult Self Report score. Both include scales for adaptive functioning, empirically based syndromes, substance use, Internalizing, Externalizing, and Total Problems. In addition, both profiles feature American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)-oriented scales, for Depressive Problems; Anxiety Problems and other diagnostic categories.
Timepoint [3] 290330 0
Baseline, post intervention and 6 month follow up
Secondary outcome [1] 244905 0
Mean Parenting Relationship Questionnaire score
Timepoint [1] 244905 0
At baseline, completion of intervention and 6 months after intervention completion by parent
Secondary outcome [2] 244906 0
Mean Millon Clinical Multiaxial Inventory-III (MCMI-III) scores. The MCMI-III assesses Axis I (clinical syndromes e.g. depressive and anxious disorders) and Axis II (e.g. personality disorder) symptoms.
Timepoint [2] 244906 0
At baseline, completion of intervention and 6 months after intervention completion by parent
Secondary outcome [3] 244907 0
Mean Adolescent Substance Abuse Subtle Screening Inventory score
Timepoint [3] 244907 0
At baseline, completion of intervention and 6 months after intervention completion by young person.
Secondary outcome [4] 244908 0
Mean Working Alliance Inventory (WAI) score. The WAI gives an overall indication of the quality of the therapeutic working relationship between therapist and client.
Timepoint [4] 244908 0
Completed twice, three weeks and eight weeks from the start of the intervention.

Eligibility
Key inclusion criteria
Using the Youth Self Report/Adult Self Report
1) a score in the clinical or subclinical range for Anxiety and/or Depression symptoms
2) a score in the clinical or subclinical range for Substance Misuse
Have a parent or carer willing to enter the evaluation
Parent/Carer and Youth must be able to speak and understand English (must not require an interpreter)
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Has an intellectual disability or autism
Has parent/s who do not wish to participate
Young person or parent has a severe mental illness requiring inpatient treatment
There is insufficient address for follow-up or unwillingness to return for follow-up

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 involves contacting the holder of the allocation schedule (research fellow) who is “off-site” at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be allocated through simple randomisation using a randomisation table created by computer software. This will be generated by a statistician in the School of Psychology, who is external to the research team.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/07/2009
Actual
20/10/2010
Date of last participant enrolment
Anticipated
Actual
16/01/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1974 0
3000
Recruitment postcode(s) [2] 1975 0
3220
Recruitment postcode(s) [3] 1976 0
3053
Recruitment postcode(s) [4] 1985 0
3121
Recruitment postcode(s) [5] 1986 0
3125
Recruitment postcode(s) [6] 1987 0
3214
Recruitment postcode(s) [7] 1988 0
3011
Recruitment postcode(s) [8] 1989 0
3030
Recruitment postcode(s) [9] 1990 0
3850
Recruitment postcode(s) [10] 1991 0
3217

Funding & Sponsors
Funding source category [1] 237374 0
Charities/Societies/Foundations
Name [1] 237374 0
Beyond Blue (independent not for profit organisation)
Country [1] 237374 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Andrew Lewis
Address
School of Psychology Deakin University
Waterfront campus, Level 3, DCP Building,
27 Brougham Street, Geelong, VIC, 3217
Country
Australia
Secondary sponsor category [1] 236870 0
Individual
Name [1] 236870 0
Professor John Toumbourou
Address [1] 236870 0
School of Psychology Deakin University
Waterfront campus, Level 3, DCP Building,
27 Brougham Street, Geelong, VIC, 3217
Country [1] 236870 0
Australia
Secondary sponsor category [2] 236871 0
Individual
Name [2] 236871 0
Associate Professor Lina Ricciardelli
Address [2] 236871 0
School of Psychology Deakin University
221 Burwood Highway
Burwood VIC 3125
Country [2] 236871 0
Australia
Secondary sponsor category [3] 236872 0
Individual
Name [3] 236872 0
Dr Tess Knight
Address [3] 236872 0
School of Psychology Deakin University
221 Burwood Highway
Burwood VIC 3125
Country [3] 236872 0
Australia
Secondary sponsor category [4] 236873 0
Individual
Name [4] 236873 0
Dr Melissa O'Shea
Address [4] 236873 0
Swanston Centre
Corner Swanston & Myers Streets
Geelong VIC 3220
Country [4] 236873 0
Australia
Other collaborator category [1] 783 0
Individual
Name [1] 783 0
Dr Melanie Bertino
Address [1] 783 0
School of Psychology Deakin University
Waterfront campus, Level 3, DCP Building,
27 Brougham Street, Geelong, VIC, 3217
Country [1] 783 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239504 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 239504 0
Ethics committee country [1] 239504 0
Australia
Date submitted for ethics approval [1] 239504 0
Approval date [1] 239504 0
05/06/2009
Ethics approval number [1] 239504 0
EC 205-2008
Ethics committee name [2] 289786 0
Barwon Health Ethics Committee
Ethics committee address [2] 289786 0
Ethics committee country [2] 289786 0
Australia
Date submitted for ethics approval [2] 289786 0
08/05/2009
Approval date [2] 289786 0
18/02/2010
Ethics approval number [2] 289786 0
09/42

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

Contacts
Principal investigator
Name 29939 0
A/Prof Andrew Lewis
Address 29939 0
School of Psychology, Deakin University, 221 Burwood Highway Burwood VIC 3125
Country 29939 0
Australia
Phone 29939 0
+61 3 9244 6774
Fax 29939 0
Email 29939 0
[email protected]
Contact person for public queries
Name 13186 0
Associate Professor Andrew Lewis
Address 13186 0
School of Psychology, Deakin University, 221 Burwood Highway Burwood VIC 3125
Country 13186 0
Australia
Phone 13186 0
+61 3 9244 6774
Fax 13186 0
Email 13186 0
[email protected]
Contact person for scientific queries
Name 4114 0
Associate Professor Andrew Lewis
Address 4114 0
School of Psychology, Deakin University, 221 Burwood Highway Burwood VIC 3125
Country 4114 0
Australia
Phone 4114 0
+61 3 9244 6774
Fax 4114 0
Email 4114 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.