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CompletedNCT06994000StressUpdated May 29, 2025

Caregiver Stress, Mental Health, and Self-Efficacy in ADHD Households

An observational study in ADHD, sponsored by Alexandria University. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-29.

Sponsored by Alexandria University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
160
Ages
18 Years to 60 Years
Sex
All
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Study summary

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).

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Conditions studied

  • ADHD

Keywords

  • Stress
  • Mental Health
  • Self-Efficacy
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In context

Attention Deficit Disorder with Hyperactivity

1,548 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.

This study's enrollment of 160 is above the median of 140 across 271 observational studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Alexandria University is the lead sponsor of 586 studies on the registry; 127 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A convenience sample of 160 participants included caregivers of children diagnosed with ADHD

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

mothers, fathers, or grandparents who are involved in the child's primary care and are between the ages of 18 and 60

Exclusion criteria

Exclusion Criteria:

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

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
160 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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."

    Time frame: 3 months

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Study locations

1 site
  • Qassim University
    Al Qassim, Al-Qassim Region, Saudi Arabia
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2024 to primary completion in Jan 2025, 4 months.

Of 69 non-industry observational studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 81. This study's 4 months is below that.

Counting every sponsor, half of 76 studies reached it within 35 months; a quarter within 20 and three quarters within 81.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2025
First posted
May 29, 2025
StartActual
Sep 1, 2024
Primary completionActual
Jan 25, 2025
CompletionActual
Feb 1, 2025
Last update
May 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06994000
Responsible party
Mahmoud Khedr (Assistant Professor, Alexandria University) — Principal investigator
First posted
May 29, 2025
Start date
Sep 1, 2024
Primary completion
Jan 25, 2025
Completion
Feb 1, 2025
Last update
May 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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