NCT05958680

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2022

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

January 7, 2022

Last Update Submit

July 20, 2023

Conditions

Keywords

behavior changephysical activityexerciseautismaspergersfeasibilityimplementation mapping

Outcome Measures

Primary Outcomes (2)

  • Feasibility of the intervention through its Adoption

    Number of people engaging with the sessions each week

    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

    3- months

Secondary Outcomes (3)

  • Self-Report Habit Index

    3- and 6-months as a follow-up

  • Basic Psychological Need Satisfaction Scale

    3 months

  • International Physical Activity Questionnaire- Short form

    3- and -6 months as a follow-up

Study Arms (1)

ASDactive

EXPERIMENTAL

Theoretically derived behaviour change intervention aimed at promoting habitual physical activity uptake

Behavioral: ASDactive

Interventions

ASDactiveBEHAVIORAL

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

ASDactive

Eligibility Criteria

Age10 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Young people aged 10-24-years diagnosed with Level 1 autism or Asperger's syndrome

You may not qualify if:

  • Physical conditions or injuries that might hinder physical activity participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katherine Parsons

Aberystwyth, Ceredigion, SY23 3UX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sedentary BehaviorAutistic DisorderAutism Spectrum DisorderAsperger SyndromeBehaviorMotor Activity

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Katherine Parsons

    Aberystwyth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Parsons

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2022

First Posted

July 24, 2023

Study Start

October 1, 2023

Primary Completion

January 1, 2024

Study Completion

October 1, 2024

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
5-years
Access Criteria
Access can be granted via Aberystwyth University

Locations