Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000574640
Ethics application status
Approved
Date submitted
4/05/2023
Date registered
25/05/2023
Date last updated
7/07/2023
Date data sharing statement initially provided
25/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Project LYRIC (Linking Youth to Resources and Interim Care): A pilot test of a brief psychological treatment to bridge wait times for youth mental health services
Scientific title
Help while our children wait: A pilot test of a brief psychological treatment to bridge wait times for youth mental health services
Secondary ID [1] 309583 0
None
Universal Trial Number (UTN)
Trial acronym
Project LYRIC (Linking Youth to Resources and Interim Care)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychological distress 329891 0
Condition category
Condition code
Mental Health 326798 326798 0 0
Depression
Mental Health 326799 326799 0 0
Anxiety
Mental Health 326800 326800 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The "Help while you wait" intervention represents a contextual adaptation of a brief psychological treatment based on Motivational Interviewing and Problem Solving Therapy which was tested in the Project MIND (PACTR201610001825403) and the ASPIRE (PACTR20200352214510) trials. In previous qualitative work, we conducted workshops and interviews with adolescents, parents and providers to identify aspects of the intervention that need to be adapted to be appropriate for the Australian context and youth culture. Most of these adaptations have been to visuals, idiom and language, with the core content of the intervention remaining unchanged.

In project LYRIC, participants assigned to the intervention condition will be offered four intervention sessions. The duration of each session is approximately 45-60 minutes. Each session is spaced about a week apart. Each session functions iteratively to build readiness to change and adaptive problem-solving and coping skills. All sessions have a motivational component, a psycho-education component, and a problem-solving component. More specifically, participants will be taught a six-step approach for addressing problems that are important and can be solved; emotional regulation strategies for dealing with unwanted thoughts and feelings; and steps for coping with problems that are important but cannot be solved. A client workbook, summarizing the content of the counselling sessions and containing worksheets to practice the problem-solving method, guides the intervention sessions. Participants will receive a PDF version of the Intervention Workbook and login details to access additional supplementary online intervention materials via the study website (www.projectlyric.com) prior to their first session. The online materials are not accessed during the face-to-face sessions but serve as supplementary materials to support skills development. Participants will be encouraged to access these resources outside of their face-to-face sessions. Each session includes take home activities to practice the skills learned between sessions. The additional worksheets and take home activities require approximately 30 minutes of time to complete on a weekly basis. Participants will not be restricted from accessing specialist mental health services or self-help (e.g., online resources) during their participation in the intervention.

The program will be delivered by program facilitators including youth workers and psychology students who will receive a minimum of 30 hours training. The training will be delivered by the program developer, a registered psychologist, and supported by other psychologists. Training will occur at least three weeks prior to the enrolment of the first participant to allow time for additional booster training to be provided if necessary and for facilitators to practice delivery of the content.

The intervention will be delivered face to face individually with a young person. The intervention will be delivered at selected headspace sites in WA and selected "The Y" youth centres. Training will detail the level of personalisation that is appropriate for the intervention, which is structured with content and activities. Intervention fidelity will be assessed with specific notes written by the program facilitator to describe deviations after the session and in a qualitative interview after intervention completion.
Intervention code [1] 326010 0
Behaviour
Intervention code [2] 326016 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care. In most cases usual care would be continuing to wait on a wait list for a mental health service and any case management usually provided by the implementation site. Participants in the control group will not be stopped from accessing additional mental health services, Participants' use of any additional services will be recorded. During the trial period, participants in the control group will be sent an email to explain the importance of their role in the trial and appointment reminders to maintain their engagement and retention for follow up surveys. Participants in the control group will have the opportunity to access the intervention after they have completed all trial-related activities.
Control group
Active

Outcomes
Primary outcome [1] 334648 0
Intervention acceptability from the perspective of adolescent participants as measured by the 19-item Child Evaluation Inventory
Timepoint [1] 334648 0
6 weeks post intervention commencement (primary endpoint), 10 weeks post intervention commencement
Primary outcome [2] 334649 0
Intervention feasibility as measured by Weiner's Feasibility of Intervention (FIM) measure from perspective of adolescents
Timepoint [2] 334649 0
6 weeks post intervention commencement (primary endpoint), 10 weeks post intervention commencement
Primary outcome [3] 334650 0
Intervention appropriateness as measured by Weiner's Intervention appropriateness measure (IAM) from the perspective of adolescents
Timepoint [3] 334650 0
6 weeks post intervention commencement (primary endpoint), 10 weeks post intervention commencement
Secondary outcome [1] 421518 0
Adolescent self-reported psychological distress as measured on the Kessler Psychological Distress Scale (K10).
Timepoint [1] 421518 0
Baseline, 6 weeks post intervention commencement, 10 weeks post-intervention commencement
Secondary outcome [2] 421520 0
Adolescent self-reported stress as measured by the Perceived Stress Scale (PSS-10).
Timepoint [2] 421520 0
Baseline, 6 weeks post intervention commencement, 10 weeks post-intervention commencement
Secondary outcome [3] 421521 0
Adolescent self-reported emotional regulation measured by the Difficulties in Emotion Regulation Scale (DERS-8).
Timepoint [3] 421521 0
Baseline, 6 weeks post intervention commencement, 10 weeks post-intervention commencement
Secondary outcome [4] 421522 0
Problem solving confidence as measured by the Multidimensional Problem-Solving Therapy Outcome Measure.
Timepoint [4] 421522 0
Baseline, 6 weeks post intervention commencement, 10 weeks post-intervention commencement
Secondary outcome [5] 421523 0
Adolescent session satisfaction as rated on a 4-item Session Rating Scale.
Timepoint [5] 421523 0
At the end of each intervention session (weekly)- secondary acceptability measure completed by adolescents.
Secondary outcome [6] 421524 0
Adolescent experiences of the intervention as reported in a qualitative interview with questions seeking to understand perceptions of its usefulness/helpfulness, content, materials, format, structure (duration), delivery, and setting.
Timepoint [6] 421524 0
10 weeks post intervention commencement
Secondary outcome [7] 421525 0
Caregiver experiences of their adolescent's participation in the program, with questions exploring benefits, challenges and impacts to themselves and their family. Interviews will also explore caregivers’ perceptions of the intervention, including the content, materials, format, structure (duration), delivery, and setting, and perceptions of their adolescent’s experience with the intervention.
Timepoint [7] 421525 0
10 weeks post intervention commencement
Secondary outcome [8] 421526 0
Facilitator experiences of delivering the intervention as reported through a qualitative interview exploring perceptions of: 1) delivering the intervention, 2) barriers to effectively and efficiently delivering the intervention, 3) strategies adopted to support the delivery within the organisation, 4) perceptions of how the intervention was received by adolescents, 5) deviations of fidelity, and 6) recommendations for the intervention format, structure (duration), delivery, and setting.
Timepoint [8] 421526 0
After the intervention has been delivered to all participants allocated to the intervention group.
Secondary outcome [9] 421527 0
Facilitator confidence in intervention delivery as measured by a 9-item measure of Confidence, Knowledge, and Skill to deliver mental health interventions.
Timepoint [9] 421527 0
Immediately post training, after the intervention has been delivered to all participants allocated to the intervention group.
Secondary outcome [10] 421529 0
Training effectiveness as measured by an 18-item Training Evaluation Scale and open ended questions on training.
Timepoint [10] 421529 0
Immediately post-training
Secondary outcome [11] 421530 0
Facilitator experiences of training as reported in a qualitative interview exploring their perceptions of the training procedures, the training evaluation, and the intervention.
Timepoint [11] 421530 0
Within three weeks of the completing training
Secondary outcome [12] 422176 0
Acceptability of intervention as assessed by Weiners Acceptability of Intervention Measure from adolescent participants perspective (additional primary outcome)
Timepoint [12] 422176 0
6 weeks post intervention commencement; 10 weeks post-intervention commencement
Secondary outcome [13] 422177 0
Acceptability of Intervention as measured by Weiner's acceptability of intervention measure- from the perspective of facilitators
Timepoint [13] 422177 0
Immediately post training, after the intervention has been delivered to all participants assigned to the intervention condition
Secondary outcome [14] 422178 0
Feasibility of the Intervention as assessed by Weiner's Feasibility of Intervention Measure- from the facilitator's perspective
Timepoint [14] 422178 0
Immediately post-training, after the intervention has been delivered to all participants assigned to the intervention condition
Secondary outcome [15] 422179 0
Appropriateness of the Intervention as assessed by Weiner's Intervention Appropriateness Measure- from the facilitator's perspective
Timepoint [15] 422179 0
Immediately post-training, after the intervention has been delivered to all participants assigned to the intervention condition

Eligibility
Key inclusion criteria
Adolescents will be eligible for this study if they:
i. are 13-19 years of age,
ii. Have consent from their primary caregiver to participate (adolescents 13-15 only) or provide consent for their own participation as mature minors (Aged 16 and above),
iii. Screen at risk for psychological distress on the K-10 (Scores =20; Kessler et al., 2002), be seeking or on wait lists for mental health services for psychological distress,
iii. are able to speak English to complete informed consent and study procedures,

Interventionists/facilitators will be eligible to participate if they:
i. Complete the required training, demonstrate competency to deliver the intervention, and agree to participate in ongoing supervision,
ii. Are able to speak English to complete informed consent and study procedures, and deliver the intervention, and
iii. Either have prior experience of working with young people at a youth/ health service, or are currently completing or recently completed a 4th-year honours-degree in Psychology, with some experience providing mental health support services.

Caregiver participants must have an adolescent child who is enrolled in the trial and be able to speak English well enough to complete informed consent and study procedures
Minimum age
13 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For adolescent participants, there are two exclusion criteria:
(i) individuals who are already engaged mental health service for regular intervention at the time of study recruitment will not be eligible for study participation.
(ii) adolescents who are assessed to be at high risk of suicide at the time of study recruitment will not be eligible for study participation and instead will be referred and linked to more appropriate supports. All potential participants will be screened for risk of suicide using the Columbia Suicide Severity Rating Scale- Screen version (Cwik et al., 2020) prior to study enrolment.

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)
After completing the online baseline assessment, adolescent participants will be randomly allocated to either the intervention or usual care comparison condition in a 1:1 ratio. The randomisation sequence will be prepared by an independent statistician (using a computer program) and allocation will be done by the trial manager. The trial manager will contact adolescent participants after they have completed the baseline survey to inform them of their allocation based on the randomisation sequence. Investigators will be blind to the sequence generation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The independent statistician will randomise participants via participant identification numbers using a random number generator computer program and advise the trial manager which group a participant ID is allocated to after enrolment of that participant. The trial manager will not know the allocation of participants prior to their enrolment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Adolescents are the primary participant group in this pilot trial. Recommendations for sample size requirements to estimate key design parameters from external feasibility and pilot randomised controlled trials suggest that at least 70 measured participants (35 per group) are required when estimating the SD for a continuous outcome. G*Power was used to determine a minimum total sample of n = 74 is required. We aim to recruit 80 adolescents, allowing for two groups of 40 participants and to account for some attrition.
To evaluate the implementation and efficacy outcomes of the intervention, we will generate descriptive statistics to describe the sample of adolescent participants, disaggregated by group (intervention vs comparison). Implementation outcomes (feasibility, acceptability, and appropriateness) will be presented descriptively and participant flow through the trial will be presented in a standard CONSORT diagram. Descriptive statistics will be reported for all other relevant secondary outcomes at each time-point by trial arm. Adjusted mean differences will be calculated for secondary clinical outcomes (psychological distress, perceived stress, emotion regulation, problem-solving confidence) comparing intervention and control groups using linear regression models, adjusting for the baseline score of the given outcome.

Caregivers and interventionists/facilitators will also participate in the trial. For the interventionist cohort we will train up to 10 facilitators to deliver the intervention, with each expected to deliver the intervention up to five participants. Similarly, we anticipate recruiting up to 10 caregivers to participate in a qualitative interview. This sample size is aligned with other pilot trials and within qualitative research guidelines for achieving information power and saturation.

We will use conventional content analysis to examine adolescent, caregiver and interventionists’ qualitative responses to open-ended questions and interview transcripts to gain further insight into their experiences with and perceptions of the intervention, as well as their feedback on the intervention’s delivery, format, and presentation. We will then triangulate within and across methodology, method, and group (Campbell et al., 2020) to generate a comprehensive overview of the intervention’s feasibility, acceptability, and appropriateness.

To evaluate the training, we will generate descriptive statistics to describe the sample of interventionists. We will then examine pre- and post-training data, comparing mean scores on the feasibility, acceptability, and appropriateness of the training, as well as interventionists’ perceived confidence, knowledge, and skill to deliver the intervention, and attitudes toward evidence-based practice. These comparisons will be descriptive in nature, as our sample will not be large enough to reliably conduct null-hypothesis significance testing. We will then combine interventionists’ responses to the quantitative and qualitative training evaluation questions to describe their experiences with and perceptions of the training.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/05/2023
Actual
29/05/2023
Date of last participant enrolment
Anticipated
28/07/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
100
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 313769 0
Charities/Societies/Foundations
Name [1] 313769 0
Channel 7 Telethon Trust
Country [1] 313769 0
Australia
Primary sponsor type
University
Name
Curtin enAble Institute
Address
Curtin enAble Institute
Kent Street Bentley, 6102
GPO Box U1987 Perth WA 6845
Country
Australia
Secondary sponsor category [1] 315605 0
None
Name [1] 315605 0
Address [1] 315605 0
Country [1] 315605 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312937 0
Curtin Human Research Ethics Committee
Ethics committee address [1] 312937 0
Ethics committee country [1] 312937 0
Australia
Date submitted for ethics approval [1] 312937 0
13/04/2023
Approval date [1] 312937 0
11/05/2023
Ethics approval number [1] 312937 0
HRE2022-0392

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

Contacts
Principal investigator
Name 126406 0
Prof Bronwyn Myers-Franchi
Address 126406 0
Curtin enAble Insititute
Kent Street Benley 6102

Postal address:
GPO Box U1987 Perth WA 6845
Country 126406 0
Australia
Phone 126406 0
+61 8 9266 2647
Fax 126406 0
Email 126406 0
[email protected]
Contact person for public queries
Name 126407 0
Caitlin Munro
Address 126407 0
Curtin enAble Insititute
Kent Street Benley 6102

Postal address:
GPO Box U1987 Perth WA 6845
Country 126407 0
Australia
Phone 126407 0
+61 8 9266 7589
Fax 126407 0
Email 126407 0
[email protected]
Contact person for scientific queries
Name 126408 0
Bronwyn Myers-Franchi
Address 126408 0
Curtin enAble Insititute
Kent Street Benley 6102

Postal address:
GPO Box U1987 Perth WA 6845
Country 126408 0
Australia
Phone 126408 0
+61 8 9266 2647
Fax 126408 0
Email 126408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain the confidentiality of individual participant data. We don't have consent to make individual data available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19088Study protocol    385837-(Uploaded-04-05-2023-14-34-09)-Study-related document.docx
19089Statistical analysis plan  [email protected]
19090Ethical approval  [email protected]
19092Clinical study report  [email protected]



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.