NCT06929858

Brief Summary

The purpose of this study is to determine if a structured training program in cognitive-behavioral strategies can improve: Self-efficacy: The belief in one's ability to succeed in specific tasks or situations. Sense of coherence: A perception of life as comprehensible, manageable, and meaningful. Psychological ownership: A sense of possession or attachment to one's job or role. These outcomes are critical for nurses working with children with ASD, as their role involves unique emotional and professional challenges. The study will use a rigorous scientific approach to assess the effectiveness of the intervention.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

April 5, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 16, 2025

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

April 4, 2025

Last Update Submit

April 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-Efficacy

    Tool: Nursing Self-Efficacy Scale, Total scores range from 10 to 40, with higher scores indicating greater self-efficacy.

    2 months

Secondary Outcomes (1)

  • Sense of Coherence

    2 months

Study Arms (2)

CBS Intervention group

EXPERIMENTAL

Interventional study gropu receives the cognitive-behavioral strategies training

Other: cognitive-behavioral strategies training

Control

NO INTERVENTION

Continues with usual practice

Interventions

A structured training program focused on cognitive-behavioral strategies tailored to the challenges of caring for children with ASD. Examples include: Techniques to manage stress (e.g., relaxation exercises). Cognitive reframing to address negative thoughts. Coping skills to enhance resilience in a demanding work environment.

CBS Intervention group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At least 6 months of experience caring for children with ASD.
  • Currently employed in a direct caregiving role for these children.

You may not qualify if:

  • Nurses with prior formal training in cognitive-behavioral therapy.
  • Nurses planning to leave their position during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zoromba MA, Alenezi A, El-Monshed AH, Loutfy A, Ali AM, Alkubati SA, El-Gazar HE. Effect of Cognitive-Behavioural Strategies on Self-Efficacy, Sense of Coherence and Psychological Ownership Among Nurses Caring for Children With Autism Spectrum Disorder: A Randomised Control Trial. J Psychiatr Ment Health Nurs. 2026 Feb;33(1):97-108. doi: 10.1111/jpm.70066. Epub 2025 Nov 24.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2025

First Posted

April 16, 2025

Study Start

April 5, 2025

Primary Completion

June 5, 2025

Study Completion

July 1, 2025

Last Updated

April 16, 2025

Record last verified: 2024-12