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Trial registered on ANZCTR


Registration number
ACTRN12612001248853
Ethics application status
Approved
Date submitted
19/11/2012
Date registered
26/11/2012
Date last updated
21/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enhancing engagement for adolescents referred for mental health treatment.
Scientific title
Enhancing engagement for adolescents referred for mental health treatment using Motivational Interviewing
Secondary ID [1] 280897 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety for adolescents referred for mental health treatment. 286970 0
Depression for adolescents referred for mental health treatment. 286971 0
Engagement for adolescents referred for mental health treatment. 286972 0
Attendance for adolescents referred for mental health treatment. 286973 0
Mechanisms of action for motivational interviewing with adolescents referred for mental health treatment. 286974 0
Therapeutic outcome for adolescents referred for mental health treatment. 286975 0
Condition category
Condition code
Mental Health 287311 287311 0 0
Depression
Mental Health 288231 288231 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Motivational Interviewing, one session approximately 50 minutes in duration prior to group therapy. These sessions will be conducted one on one by a Registered Clinical Psychologist. The group therapy will commence within two weeks following the motivational interviewing session. The group therapy will be cognitive behavioural therapy based and will be 5 weekly sessions for the duration of approximately 90 minutes. The primary facilitator for the group will be a trained mental health professional and Capital and Coast District Health Board staff member, and will be blind to the pre-treatment intervention received by group members.
Intervention code [1] 286077 0
Treatment: Other
Intervention code [2] 286078 0
Behaviour
Intervention code [3] 286113 0
Treatment: Other
Comparator / control treatment
Befriending (active control), one individual session approximately 50 minutes in duration prior to group therapy. Befriending was developed to control for nonspecific aspects of psychotherapy, and is a form of social support delivered without focusing on difficulties relating to anxiety and depression. These sessions will be conducted one on one by a Registered Clinical Psychologist. The group therapy will commence within two weeks following the befriending session. The group therapy will be cognitive behavioural therapy based and will be 5 weekly sessions for the duration of approximately 90 minutes. The primary facilitator for the group will be a trained mental health professional and Capital and Coast District Health Board staff member, and will be blind to the pre-treatment intervention received by group members.
Control group
Active

Outcomes
Primary outcome [1] 288385 0
Number of group therapy sessions attended. A record of participant attendance for each of the 5 group sessions was kept using a checklist.
Timepoint [1] 288385 0
Attendance for each of the 5 group sessions will be recorded.
Primary outcome [2] 288386 0
Readiness for treatment using a readiness ruler, and The University of Rhode Island Change Assessment Questionnaire (URICA; McConnanaughy, DiClemente & Prochaska, 1989).
Timepoint [2] 288386 0
At baseline and following intervention
Primary outcome [3] 288387 0
Symptoms of Anxiety using The Revised Children's Manifest Anxiety Scale (RCMAS; Reynolds & Richmond, 1985) and
Symptoms of Depression using the Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996).
Timepoint [3] 288387 0
At baseline, immediately following group therapy, and at 3 months follow-up.
Secondary outcome [1] 300011 0
Perceived coercion assessed using Admissions Experience Scale (Bindman, 2004).
Timepoint [1] 300011 0
Immediately following intervention.
Secondary outcome [2] 300012 0
Symptoms of Depression using the Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996).
Timepoint [2] 300012 0
At baseline, immediately following group therapy, and at 3 months follow-up.
Secondary outcome [3] 300013 0
Coping strategies using the Cognitive Emotion Regulation Questionnaire (CERQ).
Timepoint [3] 300013 0
Baseline, following group therapy and at 3 months follow up.
Secondary outcome [4] 300014 0
Client motivation for therapy as assessed by the Client Motivation for Therapy Scale (CMOTS; Pelletier, Tuson & Haddad, 1997).
Timepoint [4] 300014 0
Baseline and following intervention.
Secondary outcome [5] 300015 0
Quality of life as assessed by the Clinical Global Impressions (CGI), the Children's Global Assessment Scale (clinician rated), and the Kidscreen Questionnaire as parent and participant-rated quality of life measures.
Timepoint [5] 300015 0
Prior to the intervention, following group therapy and at 3 months follow up.
Secondary outcome [6] 300016 0
Sense of autonomy as assessed by The Adolescent Autonomy Questionnaire (Noom, 1999; Noom, Dekovic, & Meeus, 2001).
Timepoint [6] 300016 0
Baseline, and following intervention.
Secondary outcome [7] 300017 0
Personal values as assessed by an open question "What do you most value (what is important to you in your life)?
Timepoint [7] 300017 0
Baseline, and following intervention.
Secondary outcome [8] 300018 0
Therapeutic alliance will also be assessed on a session-by-session basis using the Session Rating Scale (Miller, Duncan, Brown, Sparks, & Claud, 2003).
Timepoint [8] 300018 0
Following the intervention session, and all five group therapy sessions.
Secondary outcome [9] 300019 0
Sense of self efficacy will be measured using The Perceived Competence Scale for Adolescents (PCSA; Harter 1982).
Timepoint [9] 300019 0
Baseline, and following intervention.

Eligibility
Key inclusion criteria
Individuals (males and females between 13 and 19 years of age), meeting diagnostic criteria for an anxiety or mood disorder, will be recruited through specialist mental health services.
Minimum age
13 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those individuals with a non-anxiety or mood principal diagnosis, any learning disability or other major deficits in neurocognitive functioning, or active substance abuse will be excluded.

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 concealed. Participants were randomised as they arrived for the intervention. The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated. Allocation was concealed such that the holder of the allocation schedule was off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomised cluster trial whereby individuals are randomised one of two groups for group therapy. As such in individuals in one group will have received motivational interviewing prior to the group and the other will have receieved the active control, befriending. Summary statistics for each cluster (group) will be derived.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/07/2012
Actual
24/05/2012
Date of last participant enrolment
Anticipated
Actual
25/04/2014
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
100
Accrual to date
Final
96
Recruitment outside Australia
Country [1] 4420 0
New Zealand
State/province [1] 4420 0
Wellington

Funding & Sponsors
Funding source category [1] 286345 0
University
Name [1] 286345 0
University of Otago, Wellington
Country [1] 286345 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Wellington
Address
Social Psychiatry & Population Mental Health Research Unit
University of Otago, Wellington
PO Box 7343
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 285134 0
None
Name [1] 285134 0
Address [1] 285134 0
Country [1] 285134 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288420 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 288420 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 288420 0
New Zealand
Date submitted for ethics approval [1] 288420 0
27/01/2012
Approval date [1] 288420 0
16/02/2012
Ethics approval number [1] 288420 0
LRS/12/01/002
Ethics committee name [2] 288421 0
Lower South Regional Ethics Committee
Ethics committee address [2] 288421 0
Central Regional Ethics Committee
Ministry of Health
PO Box 5013
1 The Terrace
Wellington 6011
Ethics committee country [2] 288421 0
Date submitted for ethics approval [2] 288421 0
27/01/2012
Approval date [2] 288421 0
16/02/2012
Ethics approval number [2] 288421 0
LRS/12/01/002

Summary
Brief summary
The first aim of this study is to assess whether motivational interviewing (MI), as a brief pre-treatment intervention, will enhance treatment engagement and psychotherapeutic outcome in adolescents with anxiety and depressive disorders.

The second aim is to explore factors that may be implicated in treatment adherence in the unique developmental stage of adolescence, such as, perceived coercion, sense of autonomy, sense of self-efficacy, readiness to change, motivation for therapy, symptoms of anxiety, symptoms of depression, coping strategies, and personal values. Thus, specific factors associated with the mechanisms of action of MI will also be identified.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 34475 0
Ms Shaystah Dean
Address 34475 0
Suicide and Mental Health Research Group
Dean’s Department, University of Otago, Wellington
Country 34475 0
New Zealand
Phone 34475 0
+64 4 806 1487
Fax 34475 0
Email 34475 0
[email protected]
Contact person for public queries
Name 17722 0
Ms Shaystah Dean
Address 17722 0
Suicide and Mental Health Research Group, University of Otago,Wellington PO Box 7343 Wellington Postcode 6242
Country 17722 0
New Zealand
Phone 17722 0
+64,2102174293
Fax 17722 0
Email 17722 0
[email protected]
Contact person for scientific queries
Name 8650 0
Ms Shaystah Dean
Address 8650 0
Social Psychiatry & Population Mental Health Research Unit
University of Otago, Wellington
PO Box 7343
Wellington Postcode 6242
Country 8650 0
New Zealand
Phone 8650 0
+64,2102174293
Fax 8650 0
Email 8650 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

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