NCT07604532

Brief Summary

The goal of this study is to evaluate the effect of a psycho-educational program to enhance alert consciousness and seeking support among family caregivers having children with autism. In a purposive sample of male participants diagnosed with autism. Aged from 6 to 12 years old (school age). Hypothesis: A psycho-educational program will have a positive effect after implementation on enhancing alerting consciousness and seeking support among family caregivers having children with autism. A quasi-experimental one-group pretest-post-test design was used

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

February 11, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 18, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

Autism Spectrum DisorderConsciousnessFamily CaregiversChildrenPsycho-educational Program

Outcome Measures

Primary Outcomes (2)

  • Structured interview questionnaire

    For the child: age in years, gender, number of siblings, child order, and level of education. For family caregivers: age, gender, marital status, level of education, degree of contingency, occupation, residence, and income.

    The assessment period for each participant was 12 weeks from the start of their participation in the study.

  • Clinical data tool

    clinical data for children with autism, such as enrollment in the behavioral modification program and onset of diagnosis. And family history of psychiatric or mental illness.

    The assessment period for each participant was 12 weeks from the start of their participation in the study.

Secondary Outcomes (1)

  • Brief-COPE inventory

    The assessment period for each participant was 12 weeks from the start of their participation in the study.

Study Arms (1)

Quasi-experimental one group Pre-post test

OTHER

11 core sessions to enhance alerting consciousness and seeking support among family caregivers having children with autism (4 theoretical, 7 practical) plus orientation and closure sessions, delivered over 45 to 60 minutes each. Theoretical Component (Sessions 1-4): Covered autism, management plans, challenges confronting family caregivers. Practical Component (Sessions 5-11): Focused on application across three domains: Optimism (Session 5): Optimism, definitions, concepts, and strategies for enhancement. Coping patterns (Sessions 6-11): Stress management, meditation, problem-solving, relaxation techniques, and mindfulness.

Behavioral: Psycho-educational Program

Interventions

This study aims to assess the impact of a psychoeducational program on Enhance Alerting Consciousness and Seeking Support among Family Caregivers Having Children with Autism. The program is designed to levels of alert consciousness, seeking support, overcome the challenges.

Quasi-experimental one group Pre-post test

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Family has a child with characteristics:
  • Age from 6 to 12 years old (school age).
  • Family caregivers with characteristics:
  • Be the primary caregiver at the same home and provide direct care for the children for at least 1 year.

You may not qualify if:

  • Family has child with neurological or physical disorders or a disability and doesn't have other children with special needs or disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

El Abbasia Mental Health Hospital

Cairo, El Abbasia, 11511, Egypt

Location

faculty of Nursing Ain Shams University

Cairo, El Abbasia, 11511, Egypt

Location

Related Publications (2)

  • Abdelaziz EM, Alsadaan N, Alqahtani M, Elsharkawy NB, Ouda MMA, Ramadan OME, Shaban M, Shokre ES. Effectiveness of Cognitive Behavioral Therapy (CBT) on Psychological Distress among Mothers of Children with Autism Spectrum Disorder: The Role of Problem-Solving Appraisal. Behav Sci (Basel). 2024 Jan 10;14(1):46. doi: 10.3390/bs14010046.

    PMID: 38247698BACKGROUND
  • Leadbitter K, Harrison L, Langhorne S, Ellis C, Smallman R, Pearson A, Hackett L, Kroll L, Dunkerley A, Beach H, Gilbert J, van Gils A, Hutton T, Green J, Bee P; REACH-ASD Team. The development, feasibility and acceptability of Empower-Autism: A new psychoeducational and psychotherapeutic programme for caregivers of children recently diagnosed with autism. Autism. 2025 Feb;29(2):367-381. doi: 10.1177/13623613241274566. Epub 2024 Sep 18.

    PMID: 39291754BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Nora Sa Mohamed, Assist/Lec

    Psychiatric/ Mental Health Nursing Department Faculty of Nursing - Ain Shams University

    PRINCIPAL INVESTIGATOR
  • Omayma Ab Osman, Professor

    Psychiatric/ Mental Health Nursing department Faculty of Nursing - Ain Shams University

    STUDY CHAIR
  • Afaf Mo Fahmy, Assist/Prof

    Psychiatric/Mental Health Nursing , Faculty of Nursing Ain Shams University-Cairo-Egypt.

    STUDY DIRECTOR
  • Hanaa Ez Eldin Prince, Assist/Prof

    Psychiatric/Mental Health Nursing , Faculty of Nursing Ain Shams University-Cairo-Egypt.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Psycho-educational Program
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecturer, Master's degree, Psychiatric/Mental Health Nursing Faculty of Nursing Ain Shams University-Cairo-Egypt.

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 22, 2026

Study Start

February 11, 2025

Primary Completion

April 30, 2025

Study Completion

June 1, 2025

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Study Protocol, Informed Consent Form (ICF), all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
present

Locations