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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05958680
Other study ID # 20880
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date October 1, 2024

Study information

Verified date July 2023
Source Aberystwyth University
Contact Katherine Parsons
Phone 07956986956
Email kap34@aber.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. "Proof of concept" will be tested through preliminary measures of physical activity measured before and after the intervention.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 24 Years
Eligibility 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 Design


Intervention

Behavioral:
ASDactive
An integrated theory-based intervention to promote habitual physical activity behaviours in autistic youth

Locations

Country Name City State
United Kingdom Katherine Parsons Aberystwyth Ceredigion

Sponsors (1)

Lead Sponsor Collaborator
Aberystwyth University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of the intervention through its Adoption Number of people engaging with the sessions each week 3- months
Primary 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 3- months
Secondary 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. 3- and 6-months as a follow-up
Secondary 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. 3 months
Secondary International Physical Activity Questionnaire- Short form 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
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