Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001212640
Ethics application status
Approved
Date submitted
8/08/2014
Date registered
18/11/2014
Date last updated
17/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Social Well-being and Engaged Living intervention for Australian youth at risk of mental health and other adverse outcomes
Scientific title
A telephone-delivered social well-being and engaged living intervention, compared to a manualised control or a single-session psychoeducation intervention, for improving level of engagement in education, training or employment for disengaged youth
Secondary ID [1] 284700 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotional well-being 292053 0
Social engagement 292689 0
Condition category
Condition code
Mental Health 292388 292388 0 0
Depression
Mental Health 293005 293005 0 0
Addiction
Mental Health 293006 293006 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a single-blind three-arm randomised controlled trial examining the efficacy of a telephone-delivered social well-being and engaged living (SWEL) intervention for improving the vocational, social and emotional functioning of disengaged youth.
Participants are randomized to receive either a 30-60min telephone session of Psychoeducation and Assessment Feedback, up to 8 weekly 30-60min sessions of Befriending, or up to 8 weekly 30-60min sessions of the Social Well-being and Engaged Living (SWEL) intervention.
(i) SWEL is delivered in 30-60min telephone therapy calls for up to 8 weekly sessions. Sessions may be broken into two shorter calls per week if the participant prefers. Using the Cognitive Behaviour Therapy (CBT) five areas framework the manual ensures a predominant focus on social functioning and includes modules on problem solving, self concept, behavioural activation, emotion regulation and interpersonal effectiveness. Drug and alcohol use is addressed from a stepped care model. The core targets of the intervention are emotional self efficacy (affect regulation) and social self efficacy (problem solving, sense of self and interpersonal effectiveness). Core modules are delivered in the first four sessions to maximise impact early on. The intervention is delivered by provisionally and generally registered psychologists.
Intervention code [1] 289487 0
Treatment: Other
Intervention code [2] 290302 0
Behaviour
Comparator / control treatment
(ii) Befriending: participants receive up to 8 weekly 30-60min telephone calls of a manualised control intervention developed in earlier clinical trials to address the non specific elements of psychotherapy. The Befriending intervention controls for therapist contact time, client expectancies, therapeutic alliance and therapist factors such as warmth and understanding. It does not apply any therapeutic techniques specific to major models of psychotherapy but rather is a conversational approach with a friendly focus on everyday events and topics without problem solving or examination of emotions. The intervention is delivered by provisionally and generally registered psychologists.

(iii) Single-Session Psychoeducation (including assessment feedback): this is a single 30-60min session of telephone counselling where participants receive personalised assessment feedback on their mental health functioning, social and role functioning, and level of drug and alcohol problems. Participants will then receive conversational psycho-education regarding issues considered relevant from their assessment feedback including mental health functioning, social and role functioning and level of drug and alcohol problems. The intervention is delivered by provisionally and generally registered psychologists.
Control group
Active

Outcomes
Primary outcome [1] 292489 0
Level of engagement in education, training or employment (Time-use questionnaire measuring time spent engaged in education, training and/or employment)
Timepoint [1] 292489 0
Baseline, 2 months post-Baseline, 8 months post-Baseline and 14 months post-Baseline
Secondary outcome [1] 308547 0
Social activity and Quality of Life (Social Functioning Scale of the Lehman Quality of Life Scale)
Timepoint [1] 308547 0
Baseline, 2 months post-Baseline, 8 months post-Baseline and 14 months post-Baseline
Secondary outcome [2] 308548 0
Perceived social self efficacy (Perceived Empathic and Social Efficacy Scale)
Timepoint [2] 308548 0
Baseline, 2 months post-Baseline, 8 months post-Baseline and 14 months post-Baseline
Secondary outcome [3] 308549 0
Sense of self (Rosenberg Self Esteem Scale)
Timepoint [3] 308549 0
Baseline, 2 months post-Baseline, 8 months post-Baseline and 14 months post-Baseline
Secondary outcome [4] 308550 0
Satisfaction with life (Multidimensional Adolescent Functioning Scale)
Timepoint [4] 308550 0
Baseline, 2 months post-Baseline, 8 months post-Baseline and 14 months post-Baseline
Secondary outcome [5] 308551 0
Relationship quality (Social Functioning Scale of the Lehman Quality of Life Scale)
Timepoint [5] 308551 0
Baseline, 2 months post-Baseline, 8 months post-Baseline and 14 months post-Baseline
Secondary outcome [6] 309706 0
Social and occupational functioning (measured by the Social and Occupational Functioning Assessment Scale, and the Global Functioning Scales - Social and Role)
Timepoint [6] 309706 0
Baseline, 2 months post-Baseline, 8 months post-Baseline and 14 months post-Baseline
Secondary outcome [7] 310623 0
Psychological Well-being (Kessler-10)
Timepoint [7] 310623 0
Baseline, 2 months post-Baseline, 8 months post-Baseline and 14 months post-Baseline
Secondary outcome [8] 319727 0
Resilience (Brief Resilience Scale)
Timepoint [8] 319727 0
Baseline, 2 months post-Baseline, 8 months post-Baseline and 14 months post-Baseline
Secondary outcome [9] 319728 0
Emotional, Psychological and Social Well-being (Mental Health Continuum Short Form)
Timepoint [9] 319728 0
Baseline, 2 months post-Baseline, 8 months post-Baseline and 14 months post-Baseline
Secondary outcome [10] 319729 0
Alcohol and Other Drug Use (WHO-ASSIST)
Timepoint [10] 319729 0
Baseline, 2 months post-Baseline, 8 months post-Baseline and 14 months post-Baseline

Eligibility
Key inclusion criteria
- Aged 12-25 years old
- At risk of disengagement from education, training or employment (defined as non-attendance for at least 28 days in the previous 13 weeks)
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Disengagement from school, work or other education of greater than 26 weeks
- Severe intellectual disability (determined from case manager knowledge of the participant or based on observation of apparent cognitive capacity during the screening call)
- Diagnosed psychotic disorder
- High dependence on medical care that may impede ability to re-engage with education, training or work (e.g., severe mental illness requiring hospitalisation, severe physical disability).
- Hearing impairment (assessed by case manager knowledge of the participant)
- Acute suicidality (assessed during screening call)
- Insufficient English to give informed consent (assessed by case manager on referral or by the research team during screening)

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)
Researchers will determine a participant's eligibility through the telephone screening procedure; if participants are eligible they will complete the baseline assessment including a telephone assessment with the researcher and an online self-report questionnaire. At this point, the researcher notifies the Goji Trial Management Software (through the click of a button) that the participant is at the point of randomisation and the participant is allocated to one of the three treatment conditions. This randomisation procedure is an automated process generated by a software program inaccessible to the researchers hence the researchers determining eligibility of participants only become aware of the treatment condition to which a participant is allocated after completion of screening and baseline.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated with permuted blocks and will be stratified by referral centre (Rural, Semi-rural, Urban), age group (12-18 years and 19-25 years), gender (male or female) and Aboriginal or Torres Strait Islander status (yes or no).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 279 youth (93 individuals per group) will be recruited. Allowing for a 30% loss to follow-up, the trial will have 80% power and a 5% type I error to find a Cohen's d of 0.5, i.e. moderate effect size. The significance level is adjusted by a factor of 2 to control the overall type I error rate at 5% for the 2 pair-wise comparisons required to test the primary hypotheses. This estimate is conservative and does not take into account the added power from adjusting for an individual’s measure at baseline or the repeated measures of outcome.

The primary outcome of this study will be engagement in education, training or employment (Time-Use Questionnaire). Secondary outcomes include social activity, quality of life and relationship quality (SFS), perceived social self-efficacy (Perceived Empathic and Social Efficacy Scale), sense of self (Rosenberg Self-Esteem Scale), and functioning (SOFAS, GF: Social, GF- Role, SFS, MAFS). These will be measured at baseline, end of treatment (2 months) and at 6 and 12 months post treatment).

The primary hypothesis is that the overall engagement score (calculated as actual/expected engagement in school/work/training) of youth who are randomised to active treatment (SWEL) will be higher than those randomised to either Befriending or Psycho-Education. Differences between treatment groups will be tested within a Linear Mixed Model (LMM). The outcome in the model will be individual’s total engagement score at each post treatment time point and the predictor variables in the model will include treatment group, time, the interaction between treatment group and time, baseline engagement score and the stratifying variables. The model will include a random intercept term to control for the repeated measurements on individuals. All analyses will be based on the intention to treat principle.

Differences between groups in all secondary outcomes will be tested using the same approach as outlined for the primary outcome variable. Additional LMM will be used to test for a difference between treatment groups in the trend of each of these outcomes from baseline to 12 months post-treatment using data from all time points. Subgroup analyses will be conducted to examine the similarity of the treatment effect across age groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/08/2014
Actual
22/08/2014
Date of last participant enrolment
Anticipated
31/03/2017
Actual
31/03/2017
Date of last data collection
Anticipated
Actual
14/11/2017
Sample size
Target
279
Accrual to date
Final
273
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA

Funding & Sponsors
Funding source category [1] 289498 0
Government body
Name [1] 289498 0
National Health and Medical Research Council (NHMRC)
Country [1] 289498 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
60 Musk Avenue
Kelvin Grove
Brisbane QLD 4059
Country
Australia
Secondary sponsor category [1] 288181 0
None
Name [1] 288181 0
Address [1] 288181 0
Country [1] 288181 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294099 0
Queensland University of Technology
Ethics committee address [1] 294099 0
Ethics committee country [1] 294099 0
Australia
Date submitted for ethics approval [1] 294099 0
27/06/2013
Approval date [1] 294099 0
28/11/2013
Ethics approval number [1] 294099 0
1300000403
Ethics committee name [2] 294100 0
University of Newcastle
Ethics committee address [2] 294100 0
Ethics committee country [2] 294100 0
Australia
Date submitted for ethics approval [2] 294100 0
08/01/2014
Approval date [2] 294100 0
30/04/2014
Ethics approval number [2] 294100 0
H-2014-0009
Ethics committee name [3] 294101 0
AH&MRC
Ethics committee address [3] 294101 0
Ethics committee country [3] 294101 0
Australia
Date submitted for ethics approval [3] 294101 0
17/07/2013
Approval date [3] 294101 0
16/01/2014
Ethics approval number [3] 294101 0
950/13

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

Contacts
Principal investigator
Name 48834 0
Prof Leanne Hides
Address 48834 0
School of Psychology, The University of Queensland, Lvl 2, Room 231, McElvian Building, 24A, St Lucia Campus, Brisbane, QLD 4072
Country 48834 0
Australia
Phone 48834 0
+61733656000
Fax 48834 0
Email 48834 0
[email protected]
Contact person for public queries
Name 48835 0
Leanne Hides
Address 48835 0
School of Psychology, The University of Queensland, Lvl 2, Room 231, McElvian Building, 24A, St Lucia Campus, Brisbane, QLD 4072
Country 48835 0
Australia
Phone 48835 0
+61733656000
Fax 48835 0
Email 48835 0
[email protected]
Contact person for scientific queries
Name 48836 0
Leanne Hides
Address 48836 0
School of Psychology, The University of Queensland, Lvl 2, Room 231, McElvian Building, 24A, St Lucia Campus, Brisbane, QLD 4072
Country 48836 0
Australia
Phone 48836 0
+61733656000
Fax 48836 0
Email 48836 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
SourceTitleYear of PublicationDOI
EmbaseStudy protocol: A randomised controlled trial of a telephone delivered social wellbeing and engaged living (SWEL) psychological intervention for disengaged youth.2019https://dx.doi.org/10.1186/s12888-019-2116-5
N.B. These documents automatically identified may not have been verified by the study sponsor.