ASDactive: An Integrated Theory-based Intervention to Promote Habitual Physical Activity (ASDactive)

July 20, 2023 updated by: Kathrine Parsons, Aberystwyth University

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.

Study Overview

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

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ceredigion
      • Aberystwyth, Ceredigion, United Kingdom, SY23 3UX
        • Recruiting
        • Katherine Parsons
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Katherine Parsons, Aberystwyth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

January 7, 2022

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Estimated)

July 24, 2023

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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