NCT06994000

Brief Summary

Investigate the relationship between caregiver stress, mental health, and self-efficacy in families with children who have ADHD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 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

September 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
Last Updated

May 29, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

May 20, 2025

Last Update Submit

May 20, 2025

Conditions

Keywords

StressMental HealthSelf-Efficacy

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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."

    3 months

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qassim University

Al Qassim, Al-Qassim Region, Saudi Arabia

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityPsychological Well-Being

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersPersonal SatisfactionBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 20, 2025

First Posted

May 29, 2025

Study Start

September 1, 2024

Primary Completion

January 25, 2025

Study Completion

February 1, 2025

Last Updated

May 29, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations