- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07604532
Psycho-educational Program to Enhance Alerting Consciousness and Seeking Support Among Family Caregivers Having Children With Autism
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
El Abbasia
-
Cairo, El Abbasia, Egypt, 11511
- El Abbasia Mental Health Hospital
-
Cairo, El Abbasia, Egypt, 11511
- faculty of Nursing Ain Shams University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- Family has child with neurological or physical disorders or a disability and doesn't have other children with special needs or disability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Quasi-experimental one group Pre-post test
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
The assessment period for each participant was 12 weeks from the start of their participation in the study.
|
|
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.
|
The assessment period for each participant was 12 weeks from the start of their participation in the study.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief-COPE inventory
Time Frame: The assessment period for each participant was 12 weeks from the start of their participation in the study.
|
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).
|
The assessment period for each participant was 12 weeks from the start of their participation in the study.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nora Sa Mohamed, Assist/Lec, Psychiatric/ Mental Health Nursing department Faculty of Nursing - Ain Shams University
- Study Chair: Omayma Ab Osman, Professor, Psychiatric/ Mental Health Nursing department Faculty of Nursing - Ain Shams University
- Study Director: 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.
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26.04.1229
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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