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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- 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.
- 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.
- 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
- Conditions
- Autism Spectrum Disorder
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Psycho-educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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)
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.
- First posted22 May 2026
- Study start11 Feb 2025
- Primary completion30 Apr 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nora said, Ain Shams University
- Investigators
- Nora Sa Mohamed, Assist/Lec, Principal investigator, Psychiatric/ Mental Health Nursing Department Faculty of Nursing - Ain Shams UniversityOmayma Ab Osman, Professor, Study chair, Psychiatric/ Mental Health Nursing department Faculty of Nursing - Ain Shams UniversityAfaf Mo Fahmy, Assist/Prof, Study director, Psychiatric/Mental Health Nursing , Faculty of Nursing Ain Shams University-Cairo-Egypt.Hanaa Ez Eldin Prince, Assist/Prof, Study director, Psychiatric/Mental Health Nursing , Faculty of Nursing Ain Shams University-Cairo-Egypt.
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 38247698Leadbitter 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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psycho-educational Program to Enhance Alerting Consciousness and Seeking Support Among Family Caregivers Having Children With Autism
- ClinicalTrials.gov ID
- NCT07604532
- Acronym / sponsor ID
- 26.04.1229
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Consciousness, Family Caregivers, Children, Psycho-educational Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- 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.
- 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.
- 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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Psycho-educational Program
| Arm | Type | Receives |
|---|---|---|
| Quasi-experimental one group Pre-post test | Other | Behavioral: Psycho-educational Program11 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Family has a child with characteristics:
- Family caregivers with characteristics:
Key exclusion criteria (1 listed)
- Family has child with neurological or physical disorders or a disability and doesn't have other children with special needs or disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho-educational ProgramThis 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. | Behavioural | Quasi-experimental one group Pre-post test |
Primary outcome
Structured interview questionnaire
Time frame: The assessment period for each participant was 12 weeks from the start of their participation in the study.
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.
Clinical data tool
Time frame: The assessment period for each participant was 12 weeks from the start of their participation in the study.
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.
1 secondary outcome
Brief-COPE inventory
Time frame: The assessment period for each participant was 12 weeks from the start of their participation in the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 38247698Abdelaziz 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.
- Background: PubMed 39291754Leadbitter 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.
- Individual participant dataSharing planned: Yes. Study Protocol, Informed Consent Form (ICF), all IPD that underlie results in a publication
Related trials for Autism Spectrum Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
RecruitingPhase 2
TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS
Autism Disorder
RecruitingObservational study
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Autism Spectrum Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Word Learning From Parentese in Autistic Children
Autism, Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora Sa Mohamed, Assist/Lec principal investigator
Psychiatric/ Mental Health Nursing Department Faculty of Nursing - Ain Shams University
Omayma Ab Osman, Professor study chair
Psychiatric/ Mental Health Nursing department Faculty of Nursing - Ain Shams University
Afaf Mo Fahmy, Assist/Prof study director
Psychiatric/Mental Health Nursing , Faculty of Nursing Ain Shams University-Cairo-Egypt.
2 sites in 1 country: see every site and its status.
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.