ADHDStressNCT06994000
Caregiver Stress, Mental Health, and Self-Efficacy in ADHD Households
An observational study of ADHD, run by Alexandria University at 1 site in Saudi Arabia.
Trial summary
Investigate the relationship between caregiver stress, mental health, and self-efficacy in families with children who have ADHD. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ADHD
- How many people
- 160 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2024to 1 Feb 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: A convenience sample of 160 participants included caregivers of children diagnosed with ADHD
Who may be able to join
- mothers, fathers, or grandparents who are involved in the child's primary care and are between the ages of 18 and 60
Who cannot join
- Caregivers who declined to participate in the current study, those who failed to complete the questionnaire, individuals not residing in the same household, and those not engaged in direct patient care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caring Under Pressure: The Relationship of Caregivers' Stress, Mental Health, and Self-Efficacy in ADHD Households
Investigate the relationship between caregiver stress, mental health, and self-efficacy in families with children who have ADHD.
Read the detailed description
A cross-sectional design was utilized, involving 160 caregivers from the Abdullah Al-Tamimi Autism Center in Unaizah, Saudi Arabia. Participants completed an online questionnaire that assessed sociodemographic information, caregiver stress (via the Kingston Caregiver Stress Scale), mental health (using the Mental Health Continuum-Short Form), and self-efficacy (measured by the General Self-Efficacy Scale).
- Conditions
- ADHD
- Keywords
- Stress, Mental Health, Self-Efficacy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Descriptive Group | A convenience sample of 160 participants included caregivers of children diagnosed with ADHD (inattention, hyperactivity, or a combination thereof) by a psychiatrist, following the DSM-5 TR diagnostic criteria at neurodevelopmental centers in Saudi Arabia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Stress
This study evaluates the perceived stress levels of family caregivers during the caregiving process, as developed by Kilik and Hopkins(13). This ten-item scale has been categorized into three distinct domains: caregiving (items one to seven), family issues (items eight and nine), and financial problems (item ten). The caregiving domain gauges stress from a lack of confidence in caregiving abilities, expected future care needs of the relative, and feeling overwhelmed.
Measured: 3 months
Mental Health Continuum
Utilizing the Multi-Item Checklist for Mental Health (MHC-SF), devised by Keyes et al. (2005)(15), this study meticulously investigated the emotional, social, and psychological (3,5,6 items, respectively) dimensions of the participants' health, serving as a self-reporting instrument for mental health assessment.
Measured: 3 months
General Self-Efficacy
The first edition, which had 20 items, was developed in 1997; it was then reduced to 10. Since its initial development in German, the GSE scale has undergone translations into additional languages(19). The GSES was adapted to assess individuals' perceptions of personal competence. The ten items in the updated version are graded on a 4-point scale, with one denoting "not true about me" and four denoting "totally true about me."
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Sep 2024
- Primary completion25 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Khedr, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994000
- Sponsor's protocol ID
- 607/46/4838
- Acronym
- Stress
- Status last verified
- Feb 2025
- First submitted
- 20 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring Under Pressure: The Relationship of Caregivers' Stress, Mental Health, and Self-Efficacy in ADHD Households
- ClinicalTrials.gov ID
- NCT06994000
- Acronym / sponsor ID
- Stress / 607/46/4838
- Conditions
- ADHD
- Keywords
- Stress, Mental Health, Self-Efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 29 May 2025 (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.
Investigate the relationship between caregiver stress, mental health, and self-efficacy in families with children who have ADHD.
Detailed description
A cross-sectional design was utilized, involving 160 caregivers from the Abdullah Al-Tamimi Autism Center in Unaizah, Saudi Arabia. Participants completed an online questionnaire that assessed sociodemographic information, caregiver stress (via the Kingston Caregiver Stress Scale), mental health (using the Mental Health Continuum-Short Form), and self-efficacy (measured by the General Self-Efficacy Scale).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Descriptive Group | – | –A convenience sample of 160 participants included caregivers of children diagnosed with ADHD (inattention, hyperactivity, or a combination thereof) by a psychiatrist, following the DSM-5 TR diagnostic criteria at neurodevelopmental centers in Saudi Arabia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A convenience sample of 160 participants included caregivers of children diagnosed with ADHD
Key inclusion criteria (1 listed)
- mothers, fathers, or grandparents who are involved in the child's primary care and are between the ages of 18 and 60
Key exclusion criteria (1 listed)
- Caregivers who declined to participate in the current study, those who failed to complete the questionnaire, individuals not residing in the same household, and those not engaged in direct patient care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Caregiver Stress
Time frame: 3 months
This study evaluates the perceived stress levels of family caregivers during the caregiving process, as developed by Kilik and Hopkins(13). This ten-item scale has been categorized into three distinct domains: caregiving (items one to seven), family issues (items eight and nine), and financial problems (item ten). The caregiving domain gauges stress from a lack of confidence in caregiving abilities, expected future care needs of the relative, and feeling overwhelmed.
Mental Health Continuum
Time frame: 3 months
Utilizing the Multi-Item Checklist for Mental Health (MHC-SF), devised by Keyes et al. (2005)(15), this study meticulously investigated the emotional, social, and psychological (3,5,6 items, respectively) dimensions of the participants' health, serving as a self-reporting instrument for mental health assessment.
General Self-Efficacy
Time frame: 3 months
The first edition, which had 20 items, was developed in 1997; it was then reduced to 10. Since its initial development in German, the GSE scale has undergone translations into additional languages(19). The GSES was adapted to assess individuals' perceptions of personal competence. The ten items in the updated version are graded on a 4-point scale, with one denoting "not true about me" and four denoting "totally true about me."
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 29 May 2025.
- Individual participant dataSharing planned: No
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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 ADHD, run by Alexandria University at 1 site in Saudi Arabia.
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 1 inclusion and 1 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 29 May 2025. 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 Saudi Arabia. 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?
Caregiver Stress (time frame: 3 months). The study lists 3 primary outcomes in all. 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 29 May 2025.