Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000986774
Ethics application status
Approved
Date submitted
22/06/2022
Date registered
13/07/2022
Date last updated
13/07/2022
Date data sharing statement initially provided
13/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A research study of behavioural activation treatment for depression for adolescents with mild to moderate intellectual disability
Scientific title
Behavioural activation for depression (Beat-D) in adolescents with mild to moderate learning disabilities. A feasibility randomised controlled study of Beat-D versus treatment as usual
Secondary ID [1] 306456 0
None
Universal Trial Number (UTN)
Trial acronym
Beat-D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 325293 0
intellectual disability 325294 0
Condition category
Condition code
Mental Health 322693 322693 0 0
Depression
Mental Health 322694 322694 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment is designed to be delivered to individuals alongside a parent carer. It is a structured, time limited, manualised psychological therapy, developed to treat those with an intellectual disability and depressive symptoms. There is an initial training session for carers regarding their role in the treatment, then 8-12 sessions (one hour) held weekly or every two weeks, spanning approximately 4 months. The treatment can be delivered in person, or using video conferencing.

The program is divided into two phases, starting with an assessment period (sessions 1 to 4), where the participant with intellectual disability and their carer are socialised into the model and an individual formulation is developed. Key components of this phase include: i) identifying avoidant behaviours linked to depressive symptoms and monitoring activity, ii) identifying life goals, and iii) psycho-education concerning the link between depression and activity.

The subsequent 6 active treatment sessions (sessions 5 to 10) focus on: (i) recovering lost skills and interests and new skills training, (ii) graded exposure to reduce avoidant behaviours, (iii) targeting inherently reinforcing activity and activity likely to increase access to other positive reinforcers in three life domains: domestic tasks, purposeful daytime activity and social/recreational activity, and iv) addressing other emotional or inter-personal barriers to change, including anxiety and anger.

The final two sessions (sessions 11 and 12) after the active treatment phase have a future focus and are concerned with helping the participant and carer to maintain and build on progress they have made. A booklet is prepared for the participant and carer, reviewing progress and identifying changes that have been made, along with a plan for long-term maintenance and improvement. This booklet is developed specifically for the participant and is developed collaboratively between the participant, support person, and the therapist throughout the treatment.

The participant, support person, and therapist will work together to develop therapy goals. The treatment sessions are focused on developing achievable behavioural activities that the adolescent can engage in between sessions. Activities may include social outings, recreational or hobby related activities, and exercise. The therapist, support person and adolescent will problem solve any barriers to engaging in these activities during the treatment sessions. Therapy will conclude with a review of progress and a plan for maintenance of gains.

Completion of the treatment is defined as attendance and participation in a minimum of eight sessions. This will be monitored by the completion of therapy session checklists.

The treatment will be delivered by a research assistant experienced in psychological assessment and working with people with intellectual disability, trained in the delivery of the Beat-D intervention.
Intervention code [1] 322887 0
Lifestyle
Intervention code [2] 323869 0
Behaviour
Intervention code [3] 323870 0
Treatment: Other
Comparator / control treatment
Treatment as usual (TAU).
This will include the existing treatments available in public health services and social care for adolescents with intellectual disability with depression, including anti-depressants, and any available psychological interventions. The participants will be provided with guidance for their GP on the treatment of depression for people with intellectual disability. Information will be collected from both groups about service supports and treatments they receive during the course of the study, to help describe treatment as usual and to inform the data collection methods for the economic element of a future trial.
Control group
Active

Outcomes
Primary outcome [1] 330505 0
Change in depressive symptoms measured by the self-report Glasgow Depression Scale for People with Intellectual Disability (GDS)
Timepoint [1] 330505 0
The GDS will be measured at baseline and 6-months post randomisation.
Secondary outcome [1] 406465 0
Change in depressive symptoms measured by the Glasgow Depression Scale for People with Intellectual Disability Carer Supplement (GDS-CS)
Timepoint [1] 406465 0
The GDS-CS will be completed by parents/carers at baseline and at 6 months post-randomisation.
Secondary outcome [2] 406466 0
Behavioural activation and functional engagement with activities, measured by the Behavioural Activation for Depression Scale: Short Form (BADS), adapted for adolescents with intellectual disability.
Timepoint [2] 406466 0
The BADS will be measured at baseline and at 4- and 6-months post randomisation.
Secondary outcome [3] 406467 0
Change in anxiety symptoms as measured by the self report Glasgow Anxiety Scale for People with Intellectual Disability (GAS; self-report)
Timepoint [3] 406467 0
The GAS will be completed at baseline and 6-months post randomisation
Secondary outcome [4] 406468 0
Change in anxiety symptoms as measured by the Spence Children's Anxiety Scale (Spence; parent/carer report)
Timepoint [4] 406468 0
The Spence will be completed by parents/carers at baseline and at 6 months post-randomisation.
Secondary outcome [5] 411611 0
Carer self-efficacy, measured by the Emotional Difficulties Self-Efficacy Scale (EDSE).
Timepoint [5] 411611 0
The EDSE will be completed by parents/carers at baseline and 6-months post randomisation.
Secondary outcome [6] 411612 0
Change in quality of life will be measured using the EQ-5D-Y self-report version.
Timepoint [6] 411612 0
The EQ-5D-Y self-report will be measured at baseline and 6-months post randomisation.
Secondary outcome [7] 411851 0
Change in quality of life will be measured using the EQ-5D-Y proxy version.
Timepoint [7] 411851 0
The EQ-5D-Y proxy report will be measured at baseline and 6-months post randomisation.

Eligibility
Key inclusion criteria
1. Adolescents with a mild to moderate intellectual disability, defined by a score of 70 or below on standardised assessments and deficits in adaptive functioning, and/or administratively defined as having an intellectual disability, for example, enrolled in a special school for children/adolescents with mild intellectual disability
2. Adolescents with the capacity to assent/consent to take part in the research (and therefore would have sufficient communication and understanding to take part in the treatment)
3. Aged 12-17 years
4. Clinically significant unipolar depression as determined using information gathered through clinical interview (Anxiety Disorder Interview Schedule for Children)
5. Has support from a family member or paid carer who can support them throughout the treatment
6. If on medication for depressive symptoms, have been on a stable dose for 4 weeks prior to commencement of intervention
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A suicide attempt in the past 6 months
2. Intensive inpatient treatment for mental illness in the past 6 months
3. Factors that prevent the young person from interacting with the supporter and therapist or retaining information from the therapy (for example, severe psychosis, degenerative condition)
4. Currently receiving any psychological therapy for a mental health problem
5. Insufficient English language skills to complete the measures or participate in the treatment.

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)
Following determination of eligibility for inclusion in the project, the research staff will contact the study statistician to request random allocation of the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to one of two study groups using random permuted blocks. The randomisation lists will be developed by the trial statistician, who will not be involved in recruitment, data collection, and statistical analysis.
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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/07/2022
Actual
Date of last participant enrolment
Anticipated
1/05/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 310806 0
University
Name [1] 310806 0
Monash-Warwick Alliance
Country [1] 310806 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Department of Psychiatry
School of Clinical Sciences at Monash Health
P Block, Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 312224 0
None
Name [1] 312224 0
Address [1] 312224 0
Country [1] 312224 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310375 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 310375 0
Ethics committee country [1] 310375 0
Australia
Date submitted for ethics approval [1] 310375 0
11/11/2019
Approval date [1] 310375 0
08/01/2020
Ethics approval number [1] 310375 0
19024

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

Contacts
Principal investigator
Name 117430 0
A/Prof Glenn Melvin
Address 117430 0
School of Psychology, Faculty of Health,
Deakin University, Melbourne Burwood Campus,
221 Burwood Highway, Burwood, VIC 3125
Country 117430 0
Australia
Phone 117430 0
+61 3 9244 5625
Fax 117430 0
Email 117430 0
[email protected]
Contact person for public queries
Name 117431 0
Glenn Melvin
Address 117431 0
School of Psychology, Faculty of Health,
Deakin University, Melbourne Burwood Campus,
221 Burwood Highway, Burwood, VIC 3125
Country 117431 0
Australia
Phone 117431 0
+61 3 9244 5625
Fax 117431 0
Email 117431 0
[email protected]
Contact person for scientific queries
Name 117432 0
Glenn Melvin
Address 117432 0
School of Psychology, Faculty of Health,
Deakin University, Melbourne Burwood Campus,
221 Burwood Highway, Burwood, VIC 3125
Country 117432 0
Australia
Phone 117432 0
+61 3 9244 5625
Fax 117432 0
Email 117432 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
No ethical approval (pilot feasibility study)


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
No additional documents have been identified.