Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000390482p
Ethics application status
Submitted, not yet approved
Date submitted
21/02/2025
Date registered
1/05/2025
Date last updated
1/05/2025
Date data sharing statement initially provided
1/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
An Experimental Investigation of Self-as-Context with Autistic Adults
Scientific title
Examining the Impact of Self-as-Context on Self-Compassion and Shame in a group of Autistic Adults
Secondary ID [1] 314034 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 336776 0
Self-compassion 336777 0
Shame 336778 0
Condition category
Condition code
Mental Health 333267 333267 0 0
Autistic spectrum disorders
Mental Health 333268 333268 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study consists of five phases undertaken online in one 50-minute sitting:
• Phase One (Baseline Measures; Approx. 12 minutes)
Participants will complete demographic questions and baseline psychological measures.

• Phase Two (Unpleasant Experience Recall; Approx. 8 minutes)
Participants will be asked to “Describe a time in your life where you felt out of place in the world due to being autistic” and write their response into a text box (4 minutes). Following the completion of their written experience, they will complete the momentary measures (14 items) (3 minutes).

• Phase Three (Intervention; Approx. 12 minutes)
Participants will be allocated into either the SAC or control condition.

The SAC condition will watch an 8-minute skill development video targeting a psychological process to teach them the concept of Self-As-Context. Participants will only have access to watch the video once during the study.

The intervention consists of an 8-minute guided video-based experiential exercise introducing self-as-context, a core process of psychological flexibility in Acceptance and Commitment Therapy (ACT). The video was designed and recorded specifically for this study and provides psychoeducation, a metaphor, and a guided mindfulness exercise to facilitate experiential learning and engagement with self-as-context.

The aim of the video in this study is to educate viewers to recognise they are not defined by their thoughts and feelings but are instead the observer of these experiences.

The video begins with a 1.5-minute introduction by a provisional psychologist, defining self-as-context as the part of oneself that notices inner experiences such as thoughts, feelings, memories, and sensations. It explains that self-as-context, akin to "awareness" or "consciousness," helps individuals see that they are not their thoughts or emotions but the space in which these experiences occur. Participants are encouraged to develop awareness of awareness itself.

Next, a 2-minute Sky and Weather Metaphor illustrates self-as-context. The sky represents the observer self, while changing weather represents thoughts and feelings. No matter how turbulent the weather, the sky remains unchanged, demonstrating how internal experiences are transient and do not define a person. This metaphor encourages participants to see themselves as the stable observer of their experiences.

A 4-minute experiential exercise follows, guiding participants through mindfulness practice. It begins with a brief preparation (30 seconds) where participants find a comfortable position, close their eyes, and tune into their breath. Breath awareness (30 seconds) follows, encouraging observation of natural breathing. Participants then spend 2 minutes observing their thoughts, noticing their form (images, sounds, words), velocity (fast, slow, still), and perceived location. They are reminded that if they can notice their thoughts, they are not their thoughts. The exercise concludes with 1 minute of reflection, emphasising the value of connecting with the observing self to create space for difficult experiences without suppressing them.

The final 30 seconds summarise key points, reinforcing that self-as-context helps create psychological distance from internal experiences. Participants are encouraged to continue practising this perspective in daily life. The video ends with gratitude and farewell.

o After the video, participants will answer an open-ended question as an attention and manipulation check (1 minute).
o All participants will then complete the momentary measures (14 items) (3 minutes).

• Phase Four (Re-exposure; Approx. 10 minutes)
Immediately following Phase Three, participants will re-read their written account from Phase Two (3 minutes). The SAC condition will be prompted to use the skills taught in the video. They will then complete the momentary measures (14 items) (7 minutes).

• Phase Five (Return to Baseline; Approx. 8 minutes)
All participants will watch a 2-minute calming sensory video - https://youtu.be/14XxolEJloE?si=Ha-ata512I3TQ1y- (Time stamps – 29 mins – 31 mins). They will then complete the momentary measures (14 items) (6 minutes).
Intervention code [1] 330615 0
Behaviour
Comparator / control treatment
The study consists of five phases undertaken online in one 50-minute sitting:
• Phase One (Baseline Measures; Approx. 12 minutes)
Participants will complete demographic questions and baseline psychological measures.

• Phase Two (Unpleasant Experience Recall; Approx. 8 minutes)
Participants will be asked to “Describe a time in your life where you felt out of place in the world due to being autistic” and write their response into a text box (4 minutes). Following the completion of their written experience, they will complete the momentary measures (14 items) (3 minutes).

• Phase Three (Intervention; Approx. 12 minutes)
Participants will be allocated into either the SAC or control condition.

o Participants in the control condition will watch a neutral, time-matched video (National Geographic educational clip) to control for time and attention effects (https://www.youtube.com/watch?v=nF7ZCZXyvRE&ab_channel=NationalGeographic)
o After the video, participants will answer an open-ended question as an attention and manipulation check (1 minute).
o All participants will then complete the momentary measures (14 items) (3 minutes).

• Phase Four (Re-exposure; Approx. 10 minutes)
Immediately following Phase Three, participants will re-read their written account from Phase Two (3 minutes).
o The control group will be asked only to read their written account carefully.
o Both groups will then complete the momentary measures (14 items) (7 minutes).

• Phase Five (Return to Baseline; Approx. 8 minutes)
All participants will watch a 2-minute calming sensory video - https://youtu.be/14XxolEJloE?si=Ha-ata512I3TQ1y- (Time stamps – 29 mins – 31 mins). They will then complete the momentary measures (14 items) (6 minutes).
Control group
Active

Outcomes
Primary outcome [1] 340839 0
Self-compassion
Timepoint [1] 340839 0
Group difference at T4 (end Phase 4; immediately after re-reading their written account and approximately 5 minutes after watching the video)
Primary outcome [2] 340840 0
Shame
Timepoint [2] 340840 0
Group difference measured at T4 (end Phase 4; immediately after re-reading their written account and approximately 5 minutes after watching the video)
Secondary outcome [1] 445210 0
Experiential Avoidance
Timepoint [1] 445210 0
Group difference measured at T4 (end Phase 4; immediately after re-reading their written account and approximately 5 minutes after watching the video)
Secondary outcome [2] 445211 0
Self-as-context
Timepoint [2] 445211 0
Group difference measured at T4 (end Phase 4; immediately after re-reading their written account and approximately 5 minutes after watching the video)
Secondary outcome [3] 445212 0
Self Compassion
Timepoint [3] 445212 0
T1 (end Phase 1; baseline), T2 (end Phase 2; description of emotional event), T3 (end Phase 3; immediately following viewing of intervention or control video), T4 (end Phase 4; re-reading emotional event), and T5 (end Phase 5; immediately following watching a calming video)
Secondary outcome [4] 445213 0
Shame
Timepoint [4] 445213 0
T1 (end Phase 1; baseline), T2 (end Phase 2; description of emotional event), T3 (end Phase 3; immediately following viewing of intervention or control video), T4 (end Phase 4; re-reading emotional event), and T5 (end Phase 5; immediately following watching a calming video)
Secondary outcome [5] 445214 0
Experiential Avoidance
Timepoint [5] 445214 0
T1 (end Phase 1; baseline), T2 (end Phase 2; description of emotional event), T3 (end Phase 3; immediately following viewing of intervention or control video), T4 (end Phase 4; re-reading emotional event), and T5 (end Phase 5; immediately following watching a calming video)
Secondary outcome [6] 445215 0
Self as context
Timepoint [6] 445215 0
T1 (end Phase 1; baseline), T2 (end Phase 2; description of emotional event), T3 (end Phase 3; immediately following viewing of intervention or control video), T4 (end Phase 4; re-reading emotional event), and T5 (end Phase 5; immediately following watching a calming video)

Eligibility
Key inclusion criteria
The participants must meet all of the inclusion criteria in order to be eligible to participate in the study. Criteria include:
1. Ability to understand and the willingness to indicate consent by checking to correct box following a written informed consent document.
2. All genders (Female, Male, Other)
3. 18 and older
4. Self-reported formal diagnosis of autism in childhood or adulthood
5. Willingness to adhere to the 60-minute online survey including watching two videos and answering questions.
6. Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, tablet, internet access)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for the present study include:
1. Paediatric Populations: The study focuses on identity and wellbeing processes among autistic adults. Therefore, individuals under the age of 18 are excluded as the psychological and developmental processes of interest are distinct in adult populations compared to paediatric ones.
2. Failure of Comprehension Check: Participants must demonstrate an understanding of the study tasks and procedures to ensure valid responses. Those who fail the comprehension check will be excluded to maintain the quality and reliability of the data collected.
3. Failure of Attention Checks: To ensure active and attentive participation, individuals who fail two or more attention checks during the experiment will be excluded. This criterion helps in validating that the data collected reflect genuine and thoughtful responses.

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)
The allocation sequence will be implemented through Question Pro, which will automatically assign participants to either the intervention or control group based on the sequence generated. This method ensures that the allocation sequence remains concealed from the researchers and participants until the interventions are assigned. The platform’s automated system acts like a digital equivalent of sequentially numbered, opaque, sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be generated using computer-generated random numbers through the Question Pro software. This method ensures a completely random assignment of participants to either the intervention or control group. A quota will be set to maintain a balanced allocation between the two groups. To further reduce predictability and potential bias, no additional stratification factors will be used. Details regarding any restrictions such as blocking will be documented in a separate document, which will be kept inaccessible to those involved in enrolling participants or assigning interventions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Separate 2 (group) x 4 (time) between-withing subjects repeated measures ANOVAs will be conducted to investigate the outcomes of this trial across the four dependent measures: Self-Compassion, Shame, Experiential Avoidance, Self-as-Context. Post-hoc contrasts will be used to tease apart significant results. The significance level will be set at p < 0.05, with Bonferroni corrections applied for multiple comparisons.

Primary Objective:
1. Post-hoc t-test investigating group difference at T4 on Self-Compassion
2. Post-hoc t-test investigating group difference at T4 on Shame

Secondary Objectives:
1. Post-hoc t-test investigating group difference at T4 on Experiential Avoidance
2. Post-hoc t-test investigating group difference at T4 on Self-as-Context
3. Interaction effects investigating group by time on Self-Compassion, Shame, Experiential Avoidance, Self-as-Context

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
28/06/2025
Actual
Date of last data collection
Anticipated
28/06/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 26914 0
United Kingdom
State/province [1] 26914 0

Funding & Sponsors
Funding source category [1] 318541 0
University
Name [1] 318541 0
La Trobe Univesity
Country [1] 318541 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 320937 0
None
Name [1] 320937 0
Address [1] 320937 0
Country [1] 320937 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317141 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 317141 0
Ethics committee country [1] 317141 0
Australia
Date submitted for ethics approval [1] 317141 0
21/02/2025
Approval date [1] 317141 0
Ethics approval number [1] 317141 0

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

Contacts
Principal investigator
Name 140138 0
Dr Lauren Lawson
Address 140138 0
School of Psychology and Public Health, La Trobe University, Melbourne VIC 3086
Country 140138 0
Australia
Phone 140138 0
+610394792409
Fax 140138 0
Email 140138 0
[email protected]
Contact person for public queries
Name 140139 0
Lauren Lawson
Address 140139 0
School of Psychology and Public Health, La Trobe University, Melbourne VIC 3086
Country 140139 0
Australia
Phone 140139 0
+610394792409
Fax 140139 0
Email 140139 0
[email protected]
Contact person for scientific queries
Name 140140 0
Lauren Lawson
Address 140140 0
School of Psychology and Public Health, La Trobe University, Melbourne VIC 3086
Country 140140 0
Australia
Phone 140140 0
+610394792409
Fax 140140 0
Email 140140 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The participant-level dataset will not be made publicly available to protect confidentiality, we will provide statistical code upon request. Access will be granted under the condition that the materials are used for scientific purposes.



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.