Physical InactivityASDactiveNCT05958680
ASDactive: An Integrated Theory-based Intervention to Promote Habitual Physical Activity
A study testing ASDactive in people with Physical Inactivity and Sedentary Behavior, run by Aberystwyth University at 1 site in United Kingdom.
Trial summary
ASDactive is a theory-based behaviour change intervention aimed at improving the physical activity behaviours of autistic youth. The feasibility of the intervention will be tested through interviews with participants and stakeholders. Read more about this study
- Who is it for?
- Ages 10 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Sedentary Behavior, Autism
- What is being tested?
- ASDactive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Young people aged 10-24-years diagnosed with Level 1 autism or Asperger's syndrome
Who cannot join
- Physical conditions or injuries that might hinder physical activity participation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Katherine Parsons
Aberystwyth, Ceredigion, SY23 3UX
Katherine c Parsons, BSc, 07956986956, kap34@aber.ac.uk
About this study
Official title: ASDactive: Feasibility of An Integrated Theory-based Intervention to Promote Habitual Physical Activity Behaviours in Autistic Youth
ASDactive is a theory-based behaviour change intervention aimed at improving the physical activity behaviours of autistic youth. The feasibility of the intervention will be tested through interviews with participants and stakeholders. "Proof of concept" will be tested through preliminary measures of physical activity measured before and after the intervention.
Read the detailed description
ASDactive is has been developed with guidance from autistic people and stakeholders in autism. It is informed by motivation and behaviour change theory, specifically habit theory. The intervention aims to improve the habitual exercise behaviours of autistic youth by focusing on their strengths and interests.
The feasibility study will run for 3-months, with a further 3-month follow-up period. Participants will attend motivational sessions in person where they will self-select physical activity habits to incorporate into their daily lives. They will be taught fundamental movement skills that they can use in their own leisure time. In-person sessions will be held once per fortnight with online sessions twice weekly. Participants will be encouraged to engage with as many sessions as possible, but part of the evaluation will assess uptake and engagement.
Self-determination theory and habit theory will underpin all aspects of the intervention and autistic strong interests will be embedded in the materials used.
- Conditions
- Physical Inactivity, Sedentary Behavior, Autism, Autism Spectrum Disorder, Asperger Syndrome, Behavioral
- Being tested
- ASDactive
- Keywords
- behavior change, physical activity, exercise, autism, aspergers, feasibility, implementation mapping
- Medical subject headings
- Sedentary Behavior, Autistic Disorder, Autism Spectrum Disorder, Asperger Syndrome, Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASDactiveBehavioural
An integrated theory-based intervention to promote habitual physical activity behaviours in autistic youth
| Study group | Role | What they receive |
|---|---|---|
| ASDactive | Experimental | Theoretically derived behaviour change intervention aimed at promoting habitual physical activity uptake Receives: Behavioral: ASDactive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention through its Adoption
Number of people engaging with the sessions each week
Measured: 3- months
Feasibility through Implementation
Assessment of the fidelity of the delivery sessions. Two sessions will be recorded and reviewed by two assessors to ensure they are consistently delivered according to the protocol
Measured: 3- months
Secondary outcomes (3)
Self-Report Habit Index
A scale which measures a combination of subjective estimates (never to always) and recall of behavioural frequency (number of times per week). These are then multiplied by stability of context measured by subjective evaluations (e.g., always in the same place to never in the same place). When frequency and stability are multiplied on the scale, a habit strength between 0-36 is given. Lower scores indicate poor levels of habit strength, higher scores indicated good habit strength.
Measured: 3- and 6-months as a follow-up
Basic Psychological Need Satisfaction Scale
Measures of basic psychological needs (autonomy, relatedness, and competence) measured on a 7-point likert scale from strongly disagree to strongly agree. Lower scores indicate lower levels of perceived psychological needs being met and so worse outcomes.
Measured: 3 months
International Physical Activity Questionnaire- Short form
self-report physical activity levels through open-ended questions surrounding individuals' last 7-day recall of physical activity
Measured: 3- and -6 months as a follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aberystwyth University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathrine Parsons, Aberystwyth University
- Investigators
- Katherine Parsons, Principal investigator, Aberystwyth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958680
- Sponsor's protocol ID
- 20880
- Acronym
- ASDactive
- Status last verified
- Jul 2023
- First submitted
- 7 Jan 2022
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be stored in Aberystwyth University's repository for 5-years. IPD will not include personal data belonging to participants but will include anonymised outcome data generated from self-report measures.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASDactive: Feasibility of An Integrated Theory-based Intervention to Promote Habitual Physical Activity Behaviours in Autistic Youth
- ClinicalTrials.gov ID
- NCT05958680
- Acronym / sponsor ID
- ASDactive / 20880
- Conditions
- Physical Inactivity, Sedentary Behavior, Autism, Autism Spectrum Disorder, Asperger Syndrome, Behavioral
- Keywords
- behavior change, physical activity, exercise, autism, aspergers, feasibility, implementation mapping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aberystwyth UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ASDactive is a theory-based behaviour change intervention aimed at improving the physical activity behaviours of autistic youth. The feasibility of the intervention will be tested through interviews with participants and stakeholders. "Proof of concept" will be tested through preliminary measures of physical activity measured before and after the intervention.
Detailed description
ASDactive is has been developed with guidance from autistic people and stakeholders in autism. It is informed by motivation and behaviour change theory, specifically habit theory. The intervention aims to improve the habitual exercise behaviours of autistic youth by focusing on their strengths and interests.
The feasibility study will run for 3-months, with a further 3-month follow-up period. Participants will attend motivational sessions in person where they will self-select physical activity habits to incorporate into their daily lives. They will be taught fundamental movement skills that they can use in their own leisure time. In-person sessions will be held once per fortnight with online sessions twice weekly. Participants will be encouraged to engage with as many sessions as possible, but part of the evaluation will assess uptake and engagement.
Self-determination theory and habit theory will underpin all aspects of the intervention and autistic strong interests will be embedded in the materials used.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASDactive | Experimental | Behavioral: ASDactiveTheoretically derived behaviour change intervention aimed at promoting habitual physical activity uptake |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Young people aged 10-24-years diagnosed with Level 1 autism or Asperger's syndrome
Key exclusion criteria (1 listed)
- Physical conditions or injuries that might hinder physical activity participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASDactiveAn integrated theory-based intervention to promote habitual physical activity behaviours in autistic youth | Behavioural | ASDactive |
Primary outcome
Feasibility of the intervention through its Adoption
Time frame: 3- months
Number of people engaging with the sessions each week
Feasibility through Implementation
Time frame: 3- months
Assessment of the fidelity of the delivery sessions. Two sessions will be recorded and reviewed by two assessors to ensure they are consistently delivered according to the protocol
3 secondary outcomes
Self-Report Habit Index
Time frame: 3- and 6-months as a follow-up
Basic Psychological Need Satisfaction Scale
Time frame: 3 months
International Physical Activity Questionnaire- Short form
Time frame: 3- and -6 months as a follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: Yes. IPD will be stored in Aberystwyth University's repository for 5-years. IPD will not include personal data belonging to participants but will include anonymised outcome data generated from self-report measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Parsons principal investigator
Aberystwyth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASDactive in people with Physical Inactivity and Sedentary Behavior, run by Aberystwyth University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine Parsons (07956986956, kap34@aber.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention through its Adoption (time frame: 3- months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023; AzTrials last refreshed its copy on 1 Nov 2026.