Autism Spectrum DisorderNCT06518109
Caregivers of Children With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder and Caregiver Burden, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autism Spectrum Disorder, Caregiver Burden, Exercise
- What is being tested?
- Zarit Caregiver Burden Scale
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Jun 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caregiver's Burden and Their Relationship to Physical Activity, Exercise Self-Efficacy, Perceived Exercise Benefits and Barriers in Caregivers of Children With Autism Spectrum Disorder
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.
- Being tested
- Zarit Caregiver Burden Scale
- Medical subject headings
- Autism Spectrum Disorder, Caregiver Burden, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zarit Caregiver Burden ScaleOther
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start15 Jan 2024
- Primary completion15 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güllü Aydın Yağcıoğlu, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518109
- Sponsor's protocol ID
- CCA
- Status last verified
- Feb 2024
- First submitted
- 18 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver's Burden and Their Relationship to Physical Activity, Exercise Self-Efficacy, Perceived Exercise Benefits and Barriers in Caregivers of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06518109
- Acronym / sponsor ID
- CCA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zarit Caregiver Burden ScaleThe 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) | Other | – |
Primary outcome
The Zarit Caregiver Burden Scale
Time frame: 10 minutes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Caregiver Burden, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Zarit Caregiver Burden Scale (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.