Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000835741
Ethics application status
Approved
Date submitted
24/07/2013
Date registered
30/07/2013
Date last updated
30/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of computerised cognitive behavioural therapy with mentoring for mood and behaviour among youth offenders.
Scientific title
Youth offenders rehabilitation programme plus computerised cognitive behavioural therapy compared to rehabilitation programme alone on symptoms of depression and antisocial thinking.
Secondary ID [1] 282859 0
Nil
Universal Trial Number (UTN)
U1111-1142-5427
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptoms of depression
 289668 0
Antisocial thinking and behaviour 289669 0
Condition category
Condition code
Mental Health 289988 289988 0 0
Depression
Mental Health 290017 290017 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Treatment as usual plus 'SPARX-R' computerised Cognitive Behavioural Therapy (cCBT).

Treatment as usual is the Mentoring Youth New Directions programme (MYND). This is a rehabilitation programme for youth offenders provided by the Foundation for Youth Development in New Zealand.

SPARX-R is a seven module computer-administered cognitive behavioural therapy (cCBT) programme. It is a revised version of SPARX (a tested seven module computer-administered cCBT program for adolescent depression), with minor wording modifications to minimise labelling of depression and to be more acceptable by the target population.

Participants will complete SPARX-R during their usual MYND programme hours, at a rate of approx. one to two 30 minute modules a week for seven weeks, alongside or under the supervision of their MYND social worker.
Intervention code [1] 287549 0
Treatment: Other
Intervention code [2] 287607 0
Behaviour
Comparator / control treatment
Treatment as usual.
This is the MYND community based rehabilitation programme for male adolescents, referred by the court, because of repeat offending. MYND is provided one to one, by specialist social workers. The programme content is based on individual needs assessment. It includes mentoring, supervision and support to assist participants to build skills and deal with challenges in their lives in order to reduce the risk of them re-offending and to increase their skills for participating in education, work, community and family activities. It can include referral to health, education, social or cultural services if needs are identified that can be addressed by other services. The MYND programme is delivered in the young person’s home or community, for between 6 and 30 hours per week. MYND is currently delivered by four social workers, each of whom works closely with approximately 1 out of every 4 participants in the MYND programme. The length of time that adolescents spend in the programme and the number of hours per week that they have in the programme is ordered by the court.
Control group
Active

Outcomes
Primary outcome [1] 290033 0
Mean score on the Reynolds Adolescent Depression Scale (RADS-2) for those with depressive symptoms (using the RADS-2 or CDRS-R) at baseline.
Timepoint [1] 290033 0
Baseline and at 10 and 20 weeks after entry into the MYND programme
Primary outcome [2] 290034 0
Antisocial Cognitions, measured by mean score on the 'How I Think' (HIT)questionnaire.

Timepoint [2] 290034 0
Baseline and at 10 and 20 weeks after entry into the MYND programme
Secondary outcome [1] 303815 0
Mean score on the Childrens Depression Rating Scale Revised (CDRS-R) for those with depressive symptoms(using the RADS-2 or the CDRS-R) at baseline.
Timepoint [1] 303815 0
Baseline and at 10 and 20 weeks after entry into the MYND programme
Secondary outcome [2] 303816 0
mean score on the Beck Anger Scale
Timepoint [2] 303816 0
Baseline and at 10 and 20 weeks after entry into the MYND programme
Secondary outcome [3] 303861 0
Self reported help seeking intentions. This outcome is assessed by 3 2 part questions constructed for the purposes of this trial. The items have been developed from questions included in the New Zealand adolescent health survey, Youth12, after review of the literature and consultation with MYND staff members and with an academic in the help seeking area. The items have been subject to cognitive testing with MYND participants. These are the items:

If you were down or depressed (sad, empty or angry & not enjoying things for weeks) would you try to get help from:

An adult in your family?

An adult who works with you (like a social worker, youth worker, teacher or doctor)?

If you were suicidal (wanting to killing yourself or seriously thinking about it) would you try to get help from:

An adult in your family?

An adult who works with you (like a social worker, youth worker, teacher or doctor)?

If you were feeling like you might physically hurt someone else would you try to get help from:

An adult who works with you (like a social worker, youth worker, teacher or doctor)?

Response options for each item are:
Never
Sometimes
Often
Always

The questions are delivered as a brief pen and paper questionnaire.
Timepoint [3] 303861 0
Baseline and at 10 and 20 weeks after entry into the MYND programme
Secondary outcome [4] 303862 0
Self reported physically aggressive behaviours in the last 10 weeks (in a serious physical fight; physcailly hurt someone else on purpose; carried a weapon such as a knife).
This outcome is assessed a brief pen and paper questionnaire constructed for the purposes of this trial.
These are the questions
3 In the last 10 weeks how many times have you:

Got in to a serious physical fight?
Never 1 time 2 times 3+

Physically hurt someone else on purpose?

Never 1 time 2 times 3+

Carried a weapon such as a knife?
Never 1 time 2 times 3+

These questions have been adapted from the New Zealand adolescent health survey, Youth'12. The questions have been reviewed by MYND staff and participants and advisors at the University of Auckland
Timepoint [4] 303862 0
Baseline and at 10 and 20 weeks after entry into the MYND programme
Secondary outcome [5] 303863 0
Satisfaction with SPARX-R

Using a one page Pen and paper questionnaire with likert scale options.
Timepoint [5] 303863 0
At 10 weeks (for those allocated to SPARX only)

Eligibility
Key inclusion criteria
1. Adolescents who are required to attend MYND for a minimum of 10 weeks as per court or Child Youth and Family instruction (These are 14-17 year old males who are identifed by the New Zealand Court or Child Youth and Family as recividist offenders).
2. They are able to provide written consent.
3. For those who are under the age of 16, their parents/ guardians have been informed about the study and have not advised MYND staff or the research team that they do not want their child involved.
4. They have sufficient English language ability to understand the programme.
Minimum age
14 Years
Maximum age
17 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Adolescents will be ineligible for inclusion in the trial if:
1. They have severe depression, high suicide risk or other severe mental health issue which may mean that not safe in the study. Adolescents who may require additional interventions which would not be compromised by also participating in the trial are eligible to participate (the additional interventions received will be recorded).
2. They have a disability or physical limitations that would result in them not being able to use the computer programme.

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)
1. Parental information: At the initial handover meeting the social worker will provide information for caregivers.
2. All young people enrolling in the MYND programme are allocated to one of four MYND social workers by the MYND programme director.
3 After young people are allocated a social worker, their eligiblity will be checked by MYND administration and those who are eligible will be invited to pariticipate, in the treatment arm which they would be allocated to, by a staff member who does not have responsibly for their care.

4.Allocation:
This is a prospective stepwise cohort study. This has been selected, rather than a tradititional randomised controlled trial (RCT) as social workers will be supporting clients to use SPARX-R. If they have clients using SPARX-R at the same time as others who are not using SPARX-R, there is considerable potential for contamination of the control condition.

Participants will be allocated using the following schedule:
- For the first seven weeks of the study, all young people who enrol in MYND, or have been enrolled in MYND in the previous three weeks, will be invited to participate in the study, in the MYND only condition. This is Step 1.
- The following forty weeks are divided into four ten week blocks. The four MYND social workers will be randomised to beginning SPARX-R with all their new consenting clients during one of these blocks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The four social workers will be randomised to beginning SPARX in the 2nd, 3rd, 4th or 5th block using a computer generated randomisation sequence which will be carried out off the MYND site by an independant statistican.

Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study design was developed because of the concern regarding contamination of the control condition.

In addition, participants giving consent after randomisation is considered an advantage. In an RCT participants are required to understand randomisation before giving consent and to give consent interventions that they may not receive. This complexity may not be appropriate for people are in complex or challenging situations. If people are offered an intervention that they don’t receive, this may result in differential drop-out rates and potential ‘resentful demoralisation’.

A stepwise cohort study is proposed, rather than a simple before and after cohort study, as this provides greater potential for separating possible effects of the intervention from the effects of time and from extraneous variables.

Participants will be offered a choice regarding who will carry out assessments with them out of the following: their usual MYND social worker, another trained MYND staff member, a University of Auckland researcher.

This approach has been selected as consultation of MYND programme participants and staff suggest that many participants are not likely to trust assessors that they do not know well. That is, both staff and young people currently in the MYND programme have advised that requiring participants to complete self-report scales and interviews with someone they did not know well, is likely to result in very low levels of disclosure of personal information and high levels of mis-information being provided, at least for some participants. The MYND social workers are required to have a high level of skill in developing trusting relationships with young people and this is a focus of their work. Hence it is proposed that participants may elect to have their usual MYND social worker carry out assessments with them. However, some participants may feel more comfortable carrying out assessments with a person they know moderately well or do not know. Hence options of another MYND staff member or a University of Auckland researcher are also provided.

Participants will be asked to use the same assessor for all three assessments.

The MYND social workers will be the assessors for participants who choose this. These assessors will be aware of treatment allocation; hence there is not routine blinding of assessors.

To reduce the impact of potential assessor bias the following steps will be taken:
* The primary outcome measures are self-report (not assessor rated) questionnaires
* All assessors will be trained in the administration of the self-report questionnaires and the CDRS-R (this is the only assessor rated measure used). Training for the CDRS-R will utilise video recorded CDRS-R interviews and trainers will ensure assessors achieve high inter-rater reliability with trained child and adolescent mental health professionals. ---* Assessors will request participant’s permission to audio record CDRS-R assessments. All audio recordings will be forwarded to the research team. At least 10% of audio recorded CDRS interviews will be randomly selected and will be scored by a trained researcher who is blind to the participant’s allocation. An independent statistician will review researcher and assessor score to test for systematic differences by treatment allocation.
*All completed questionnaires and rating scales will be placed into a sealed envelope and will be forwarded to the research team when each assessment is completed.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will be an Intention to Treat (ITT) analysis. Changes from baseline to 10 and 20 weeks assessment data will be compared between treatment groups using a repeated measures ANOVA.

A sample size of 100 will be sought. Eighty participants will enable a moderate effect size (a change in raw score on the RADS-2 of at least 5.5 points) to be shown as statistically significant (2-tailed a = 0.05) with 80% power. This is based on an assumption that the standard deviation RADS-2 baseline to 10 week change score is about 12.5 points. Hence, a sample size of 100 will be sought, to allow for 20% drop out

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2013
Actual
Date of last participant enrolment
Anticipated
1/08/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5228 0
New Zealand
State/province [1] 5228 0
Auckland

Funding & Sponsors
Funding source category [1] 287638 0
Charities/Societies/Foundations
Name [1] 287638 0
The Foundation for Youth Development (FYD)

NB The Foundation for Youth Development is funding the study partly with funds obtained from the Auckland Council Community Crime Prevention Fund. This latter organisation is not listed separately as a funder as it is not directly funding the study.
Country [1] 287638 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 286380 0
Charities/Societies/Foundations
Name [1] 286380 0
The Foundation for Youth Development
Address [1] 286380 0
6 Triton Drive, Albany, Auckland 0632
Country [1] 286380 0
New Zealand
Other collaborator category [1] 277529 0
University
Name [1] 277529 0
The Department of Psychological Medicine, University of Auckland
Address [1] 277529 0
The University of Auckland
Private Bag 92019
Auckland 1142
Country [1] 277529 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289609 0
Health and Disability Ethics Committee
Ethics committee address [1] 289609 0
Ethics committee country [1] 289609 0
New Zealand
Date submitted for ethics approval [1] 289609 0
31/05/2013
Approval date [1] 289609 0
11/06/2013
Ethics approval number [1] 289609 0
13/NTA/79

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

Contacts
Principal investigator
Name 41538 0
Dr Theresa (Terry) Fleming
Address 41538 0
University of Auckland
Private Bag 92019
Auckland 1142
Country 41538 0
New Zealand
Phone 41538 0
+64 21 2249 373
Fax 41538 0
Email 41538 0
[email protected]
Contact person for public queries
Name 41539 0
Bridgette Gillham
Address 41539 0
The Foundation for Youth Development
6 Triton Drive
Rosedale
Auckland 0632
Country 41539 0
New Zealand
Phone 41539 0
+64 272179217
Fax 41539 0
Email 41539 0
[email protected]
Contact person for scientific queries
Name 41540 0
Theresa (Terry) Fleming
Address 41540 0
University of Auckland
Private Bag 92019
Auckland 1142
Country 41540 0
New Zealand
Phone 41540 0
+64 21 2249 373
Fax 41540 0
Email 41540 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Fleming TM, Gillham B, Bavin LM, Stasiak K, Lewyck... [More Details]

Documents added automatically
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