ASDactive: An Integrated Theory-based Intervention to Promote Habitual Physical Activity (ASDactive)
Primary Purpose
Physical Inactivity, Sedentary Behavior, Autism
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ASDactive
Sponsored by
About this trial
This is an interventional basic science trial for Physical Inactivity focused on measuring behavior change, physical activity, exercise, autism, aspergers, feasibility, implementation mapping
Eligibility Criteria
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
Sites / Locations
- Katherine ParsonsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASDactive
Arm Description
Theoretically derived behaviour change intervention aimed at promoting habitual physical activity uptake
Outcomes
Primary Outcome Measures
Feasibility of the intervention through its Adoption
Number of people engaging with the sessions each week
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
Secondary Outcome Measures
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.
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.
International Physical Activity Questionnaire- Short form
self-report physical activity levels through open-ended questions surrounding individuals' last 7-day recall of physical activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05958680
Brief Title
ASDactive: An Integrated Theory-based Intervention to Promote Habitual Physical Activity
Acronym
ASDactive
Official Title
ASDactive: Feasibility of An Integrated Theory-based Intervention to Promote Habitual Physical Activity Behaviours in Autistic Youth
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aberystwyth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. "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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Inactivity, Sedentary Behavior, Autism, Autism Spectrum Disorder, Asperger Syndrome, Behavioral
Keywords
behavior change, physical activity, exercise, autism, aspergers, feasibility, implementation mapping
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASDactive
Arm Type
Experimental
Arm Description
Theoretically derived behaviour change intervention aimed at promoting habitual physical activity uptake
Intervention Type
Behavioral
Intervention Name(s)
ASDactive
Intervention Description
An integrated theory-based intervention to promote habitual physical activity behaviours in autistic youth
Primary Outcome Measure Information:
Title
Feasibility of the intervention through its Adoption
Description
Number of people engaging with the sessions each week
Time Frame
3- months
Title
Feasibility through Implementation
Description
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
Time Frame
3- months
Secondary Outcome Measure Information:
Title
Self-Report Habit Index
Description
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.
Time Frame
3- and 6-months as a follow-up
Title
Basic Psychological Need Satisfaction Scale
Description
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.
Time Frame
3 months
Title
International Physical Activity Questionnaire- Short form
Description
self-report physical activity levels through open-ended questions surrounding individuals' last 7-day recall of physical activity
Time Frame
3- and -6 months as a follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Parsons
Phone
07956986956
Email
kap34@aber.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Parsons
Organizational Affiliation
Aberystwyth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katherine Parsons
City
Aberystwyth
State/Province
Ceredigion
ZIP/Postal Code
SY23 3UX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine c Parsons, BSc
Phone
07956986956
Email
kap34@aber.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
5-years
IPD Sharing Access Criteria
Access can be granted via Aberystwyth University
Learn more about this trial
ASDactive: An Integrated Theory-based Intervention to Promote Habitual Physical Activity
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