NCT06518109

Brief Summary

This study aims to examine the relationship between caregiving burden and physical activity, exercise self-efficacy, and perceived exercise benefits and barriers in caregivers of Caregivers of children with autism spectrum disorder (CwASD).The study population consisted of primary caregivers of a CwASD for at least 1 year. Caregiving burden was assessed using the Zarit Caregiver Burden Scale, physical activity using the International Physical Activity Questionnaire-Short form (IPAQ-SF), exercise self-efficacy using the Exercise Self-Efficacy Scale, and perceived exercise benefit using the Exercise Benefits/Barriers Scale. The relationship between caregiver burden and other parameters was analysed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
Last Updated

July 25, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

July 18, 2024

Last Update Submit

July 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Zarit Caregiver Burden Scale

    The Zarit Caregiver Burden Scale (ZCBS) is a widely used instrument for assessing the burden experienced by caregivers of individuals requiring long-term care. It consists of 22 items and the total score ranges from 0 to 88 (low/no burden to severe burden)

    10 minutes

Interventions

The Zarit Caregiver Burden Scale (ZCBS) is a widely used instrument for assessing the burden experienced by caregivers of individuals requiring long-term care. It consists of 22 items and the total score ranges from 0 to 88 (low/no burden to severe burden)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population were being over 18 years of age, caring for a CwASD for at least 1 year, the child with autism being 18 years of age or younger, being an informal caregiver, and the caregiver being the person with primary responsibility for caring for the CwASD in the family.

You may qualify if:

  • Over 18 years of age,
  • Caring for a CwASD for at least 1 year,
  • The child with autism is 18 years old or younger,
  • being an informal carer,
  • The caregiver is the person with primary responsibility for the care of the CwASD in the family.

You may not qualify if:

  • People over the age of 65,
  • Those without a diagnosed chronic physical condition leading to disability,
  • Those caring for more than one CwASD, another disabled person, an older adult or someone needing care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Ankara, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum DisorderCaregiver BurdenMotor Activity

Interventions

Zarit Caregiver Burden Scale

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 18, 2024

First Posted

July 24, 2024

Study Start

January 15, 2024

Primary Completion

May 15, 2024

Study Completion

June 15, 2024

Last Updated

July 25, 2024

Record last verified: 2024-02

Locations