- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05958680
ASDactive: An Integrated Theory-based Intervention to Promote Habitual Physical Activity (ASDactive)
ASDactive: Feasibility of An Integrated Theory-based Intervention to Promote Habitual Physical Activity Behaviours in Autistic Youth
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Katherine Parsons
- Phone Number: 07956986956
- Email: kap34@aber.ac.uk
Study Locations
-
-
Ceredigion
-
Aberystwyth, Ceredigion, United Kingdom, SY23 3UX
- Recruiting
- Katherine Parsons
-
Contact:
- Katherine c Parsons, BSc
- Phone Number: 07956986956
- Email: kap34@aber.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Young people aged 10-24-years diagnosed with Level 1 autism or Asperger's syndrome
Exclusion Criteria:
- Physical conditions or injuries that might hinder physical activity participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ASDactive
Theoretically derived behaviour change intervention aimed at promoting habitual physical activity uptake
|
An integrated theory-based intervention to promote habitual physical activity behaviours in autistic youth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the intervention through its Adoption
Time Frame: 3- months
|
Number of people engaging with the sessions each week
|
3- months
|
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- months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Report Habit Index
Time Frame: 3- and 6-months as a follow-up
|
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.
|
3- and 6-months as a follow-up
|
Basic Psychological Need Satisfaction Scale
Time Frame: 3 months
|
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.
|
3 months
|
International Physical Activity Questionnaire- Short form
Time Frame: 3- and -6 months as a follow-up
|
self-report physical activity levels through open-ended questions surrounding individuals' last 7-day recall of physical activity
|
3- and -6 months as a follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katherine Parsons, Aberystwyth University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20880
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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