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Trial registered on ANZCTR


Registration number
ACTRN12612000398808
Ethics application status
Approved
Date submitted
26/03/2012
Date registered
10/04/2012
Date last updated
31/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Engaging Youth using Family Based Interventions
Scientific title
Engaging youth with high prevalence mental health problems using family based interventions
Secondary ID [1] 280036 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 285951 0
Condition category
Condition code
Mental Health 286138 286138 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour Exchange Systems Training - MOOD (BEST-MOOD) Intervention.

The BEST-MOOD program is a fully manualised and evidence supported treatment. This professionally-led group program consists of 8 weekly two-hour sessions designed to assist concerned parents and families to effectively initiate changes to reduce youth mental health (YMH) problems, such as depression and alcohol or other drug (AOD) misuse. Youth are invited to join their parents in the group from week 5. The active components of the BEST program are: to encourage self-care; skills in family communication; boundary setting; clarification or roles within the family; clarification of family goals to reinforce parental vision and leadership; mental health literacy; improved support for all family members; support from other group members and homework tasks related to these treatment components.
Intervention code [1] 284360 0
Treatment: Other
Comparator / control treatment
Parenting Adolescent Support Training (PAST).

The Parenting Adolescent Support Training (PAST) assists parents to articulate and identify concerns, clarify issues, provide mutual support and problem solving within the group and provides psycho-education to increase parents’ knowledge of youth drug use and/or mental health problems. It is a fully manualised intervention designed to mirror current treatment offered to parents in the community, and consists of 8 weekly two-hour group counselling sessions for parents, with youth invited to join at session 5.The therapy uses a model based on an amalgamation of the Leading a Support Group manual by Keith Nichols (clinical psychologist, senior lecturer) and John Jenkinson (consultant and trainer, counsellor, and alcohol and drugs consultant; and the ‘Non Directive Therapy’ devised and evaluated in several studies by David Brent (MD, Academic Chief and Child and Adolescent Psychiatry Director, Dept of Psychiatry, University of Pittsburgh) for adolescent depression. Under this model, meetings are organised where parents with similar problems can meet and share experiences and strategies and a staff member facilitates the group. The main content of such groups is support and the opportunity to share experiences and ideas. Educational resources are provided. Equivalent training to the BEST-MOOD condition (workshop, supervision and manual) will be delivered to similarly qualified group facilitators to run the control condition.
Control group
Active

Outcomes
Primary outcome [1] 286610 0
Parental and youth mental health will improve in response to both interventions. There will be a difference in youth mental health outcomes based on level of engagement with treatments, with greater engagement rates for youth being associated with greater improvements in youth mental health outcomes.

Methods

Mental health outcomes:
1) Youth Depression, youth reported: The SCID-CV current major depression symptoms will be administered to youth via telephone as a screening tool for admission to the study, and repeated at T2 and T3 to assess improvements in symptoms. The Achenbach Adult Self Report/Youth Self Report internalising subscale will also be administered to consenting youth at T1, T2, and T3
2) Adolescent Mental Health, parent reported: Adolescent mental health will be further assessed using the Child Behaviour Checklist / Adult Behaviour Checklist, completed by parents
3) Parent mental health: Mental health of both parents will be assessed using the Achenbach ASR (adult self report)

Engagement outcomes:

Engagement will be measured in two ways:
1) Using a purpose designed clinician rated measure, based on the following objective criteria. These criteria will be (a) attendance at a psychological service to which they will be provided a referral (b) completion of previous treatments if offered at other services and (c) attendance at the Parenting Group when invited (after week 4). Engagement in treatment will be rated at the beginning and end of intervention and reported as a continuous score. This measure will also be evaluated and published in a separate validation study
2) Using the URICA: Stages of Change questionnaire, administered to all family members at the pre, post and follow up
Timepoint [1] 286610 0
Baseline (T1)
Following completion of treatment (T2)
At a 6-month follow up (T3)
Primary outcome [2] 286611 0
There will be a difference between groups in the number of youth engaging in individual treatments following the course of family based interventions.

Methods

At the outset and conclusion of either intervention (i.e. BEST-MOOD and PAST), youth will be offered a referral for psychological treatment, at an appropriate local service. Parents will be asked to report on whether their child has engaged in a service for psychological treatment, prior to starting in a group, at the conclusion of the group and the 6-months follow up assessment. This will enable the research team to determine whether either intervention has facilitated youth engagement, in psychological treatment.
Timepoint [2] 286611 0
Baseline (T1)
Following completion of treatment (T2)
At a 6-month follow up (T3)
Secondary outcome [1] 296268 0
A therapeutic process study will be embedded within the outcome study to examine therapist, process and treatment fidelity variables.

Methods

Therapist-client alliance: The Working Alliance Inventory will be used to assess the quality of the working relationship between the therapist and the clients participating in the BEST-MOOD and PAST sessions. A selection of sessions will be observed by a post graduate clinical psychology student, who will keep a written log of group content and processes. Sessions will also be recorded and sections of this transcribed, to assess degree of fidelity to the respective manuals and effective use of therapeutic processes. Several sessions will be randomly selected and rated by the senior supervisor on a 10 item fidelity scale developed for each arm of treatment.

Process Measures: Interviews will be conducted with those who a) did not take up the option of treatment following intake/assessment, b) discontinued treatment, and c) completed treatment.
Timepoint [1] 296268 0
Baseline (T1)
Following completion of treatment (T2)
At a 6-month follow up (T3)

Eligibility
Key inclusion criteria
1) A score in the clinical or sub clinical range for youth Depression symptoms assessed via the SCID-CV
Minimum age
12 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Intellectual disability, severe cognitive impairment, pervasive developmental disorders or psychosis in youth or parents
2) Parents or youth presenting with severe mental illness requiring inpatient treatment or otherwise limiting their ability to participate in a group program
3) Inability to understand written or spoken English language
4) 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)
Group assignment will be pre-printed using a computer program and sealed in sequentially numbered envelopes, which will be opened in sequential order by the intake clinician – who will assign this code to each new family entering the study following completion of the intake, consent and pre-measures. When the required number of participants to fill a group has been reached, the details for attending the group will be given to participants to commence treatment. All subjects (regardless of their degree of future participation), will be considered part of the study from the point of randomisation (an intent-to-treat design).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Qualifying families will be randomised to one of the two groups, using a blocked procedure to ensure that group assignments are never significantly imbalanced, generated prior to recruitment.
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284795 0
Government body
Name [1] 284795 0
The Australian Research Council
Address [1] 284795 0
Level
2, 11 Lancaster Place Majura Park ACT 2609
Country [1] 284795 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
drummond street services and Eastern Health (Turning Point)
Address
195 Drummond Street Carlton VIC 3053

54 - 62 Gertrude Street
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 283677 0
Charities/Societies/Foundations
Name [1] 283677 0
beyondblue: the national depression initiative and the Australian Drug Foundation
Address [1] 283677 0
PO Box 6100
Hawthorn West VIC 3122

409 King St West Melbourne VIC 3003
Country [1] 283677 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286782 0
Eastern Health Research Ethics Committee
Ethics committee address [1] 286782 0
70 Arnold Street, Box Hill
Ethics committee country [1] 286782 0
Australia
Date submitted for ethics approval [1] 286782 0
24/01/2012
Approval date [1] 286782 0
15/06/2012
Ethics approval number [1] 286782 0

Summary
Brief summary
Intake or phone counsellor screening occurs already though these services, for presenting issues and risk. These services will identify appropriate referrals during their routine service provision to identify parents who might be eligible and benefit from the programs. The identified potential participants will then be given the telephone contact number for the clinical intake worker on our research team. The intake worker will administer a standardized interview assessing the inclusion and exclusion criteria, and other important clinical information. Participants who are referred and screened but do not meet criteria for the programs will be offered suitable alternative referrals.
Trial website
http://www.deakin.edu.au/hmnbs/psychology/research/dfo
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33841 0
Address 33841 0
Country 33841 0
Phone 33841 0
Fax 33841 0
Email 33841 0
Contact person for public queries
Name 17088 0
A/Prof Andrew Lewis
Address 17088 0
221 Burwood Highway, Burwood VIC 3125
Country 17088 0
Australia
Phone 17088 0
+61 03 9254-6774
Fax 17088 0
Email 17088 0
andrew.lewis@deakin.edu.au
Contact person for scientific queries
Name 8016 0
A/Prof Andrew Lewis
Address 8016 0
221 Burwood Highway, Burwood VIC 3125
Country 8016 0
Australia
Phone 8016 0
+61 03 9254-6774
Fax 8016 0
Email 8016 0
andrew.lewis@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
No Results