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Autism Spectrum DisorderNCT07604532

Psycho-educational Program to Enhance Alerting Consciousness and Seeking Support Among Family Caregivers Having Children With Autism

A study testing Psycho-educational Program in people with Autism Spectrum Disorder, run by Ain Shams University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Psycho-educational Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesEgypt
Study dates
11 Feb 2025to 1 Jun 2025
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites
  • El Abbasia Mental Health Hospital

    Cairo, El Abbasia, 11511

  • faculty of Nursing Ain Shams University

    Cairo, El Abbasia, 11511

Other trials in Egypt

About this study

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

Read the detailed description
  1. Introduction and Rationale According to the World Health Organization (WHO), the prevalence of ASD worldwide is 1 in every 100 children. The prevalence of ASD in Egypt is estimated at 5.4/1000 among Egyptian children. Children with ASD impose distinct challenges on their family caregivers due to being unable to cope effectively, including financial, physical, and psychological challenges, which can lead to significant stress, burden, and pessimism. So, it's important for a psychoeducational program to support caregivers who have children with ASD to deal with their psychological problems as well as find alerting consciousness and seek support that increases their life satisfaction and quality of life that enables caregivers to deal with their children suffering. Caregivers can employ both sorts of coping strategies concurrently, and their efficacy can impact the overall welfare of the family. These include seeking guidance and assistance from healthcare professionals and support groups, establishing regular routines and structures in daily life, and engaging in mindfulness and relaxation techniques. In addition, certain caregivers may employ alerting consciousness. It is crucial to acknowledge that the efficacy of coping methods might differ among parents, and the selection of coping strategy may be influenced by the individual's personal traits, the intensity of the child's symptoms, and the presence of social support. This study aimed to evaluate the effect of a psycho-educational program to enhance alert consciousness and seeking support among family caregivers having children with autism.
  2. Study Objectives and Hypothesis Primary Aim: evaluate the effect of a psycho-educational program to enhance alert consciousness and seeking support among family caregivers having children with autism. Primary 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.
  3. Methods 3.1. Study Design: A quasi-experimental, one-group pre-test/post-test design was employed.

3.2. Setting: at an autistic center affiliated to El-Abbasia psychiatric and mental Hospital in Cairo, Egypt.

3.3. Participants: A purposive sample of family caregivers of children with autism registered in the previously mentioned setting was recruited. Inclusion criteria were related to the child: Age from 6 to 12 years old (school age) and No neurological or physical disorders or disability. Also, regarding to family caregivers: Be the primary caregiver at the same home and provide direct care for the children at least 1 year, and don't have other children with special needs or disabilities.

Sample size was determined via power analysis (α=0.05, β=0.15) based on a previous study.

3.4. Intervention (a psycho-educational program): The researcher-developed program, reviewed by supervisors and grounded in literature, comprised 11 core sessions (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 applied across three domains:

Optimism (Sessions 5): Optimism, definitions, concepts, and strategies for enhancement

Coping patterns (Sessions 6-11): Stress management, meditation, problem solving, relaxation techniques, and mindfulness.

Pedagogy: Interactive methods were used, including open discussions, brainstorming, role-playing, demonstrations, videos, and handouts. Each session included homework review, feedback, objective setting, and a Q\&A period.

3.5. Data Collection Tools:

Tool I: Interview Questionnaire Collected socio-demographic and clinical data 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.

Tool II: Clinical data tool: : assesses 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.

Tool III: Brief-COPE inventoryIt was used to assess alerting consciousness and seeking support among family caregivers of children with ASD. It consists of 28 items presented in the form of a coping statement, and the responses ranged from: I have not been doing this at all (1), to I have been doing this a lot (4). scoring system: ;The alerting consciousness and seeking support of the caregivers of children with autism were considered ineffective if the score was < 50% and effective if the percent score was ≥ 50%.Demonstrated high reliability in this study (Cronbach's α = 0.968).

3.6. Data Collection Procedure: The 6-month study (Feb-June 2025) followed stages: ethical approvals, baseline (pre-test) data collection using Tools I and II, program implementation n=50 post-test) 3.7. Statistical Analysis: Data were analyzed using SPSS v26. Descriptive statistics (frequencies, percentages, means, standard deviations) described the sample. A paired t-test was used to compare pre- and post-intervention self-efficacy scores, with a significance level of p < 0.05.

Ethics: Approved by the Faculty of Nursing, Ain Shams University IRB (ID: 26.041229). Informed consent was obtained from all participants

Being tested
Psycho-educational Program
Keywords
Autism Spectrum Disorder, Consciousness, Family Caregivers, Children, Psycho-educational Program
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psycho-educational ProgramBehavioural

    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.

Study groups in NCT07604532
Study groupRoleWhat they receive
Quasi-experimental one group Pre-post testOther11 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.
Receives: Behavioral: Psycho-educational Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (1)
  1. Brief-COPE inventory

    It was used to assess alerting consciousness and seeking support among family caregivers of children with ASD. It consists of 28 items presented in the form of a coping statement, and the responses ranged from "I have not been doing this at all" (1) to "I have been doing this a lot" (4).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start11 Feb 2025
  3. Primary completion30 Apr 2025
  4. Study completion1 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Psycho-educational Program
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07604532
Sponsor's protocol ID
26.04.1229
Status last verified
May 2026
First submitted
18 May 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study Protocol, Informed Consent Form (ICF), all IPD that underlie results in a publication

Publications

  • 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.

    PubMed 38247698
  • 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.

    PubMed 39291754

Questions about this trial

What is this clinical trial studying?

A study testing Psycho-educational Program in people with Autism Spectrum Disorder, run by Ain Shams University at 2 sites in Egypt.

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 4 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. 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?

Structured interview questionnaire (time frame: The assessment period for each participant was 12 weeks from the start of their participation in the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07604532, which also lists 2 linked publications.

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 22 May 2026.

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