- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05568303
the Role of Problem Solving in Cognitive Behavioral Therapy for Mothers With Autistic Children
The Effect of Cognitive Behavioral Therapy on Psychological Distress Among Mothers of Children With Autism Spectrum Disorders: The Role of Problem-Solving Appraisal
Cognitive behavioral therapy sessions can effectively reduce distress in mothers of children with autism. here we emphasize on the role of problem solving appraisal in CBT sessions to improve problem solving skills ability and minimize psychological distress . pre- intervention assessment (T1) for all participants , then designed 8 sessions for study group will apply .
post intervention assessment (T2) will conduct immediately after CBT sessions
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beera
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Behera Governate, Beera, Egypt, 22516
- Governmental Clinic
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-
-
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Jouf, Saudi Arabia, 00966
- Enas Mahrous Abdelaziz
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Mothers caregivers who have:
- A child with autism spectrum disorders diagnosed science at least 6 months , and her/ his diagnosis done by a psychiatrist
- Just one child with autistic disorder
- Their ages between 20-50 years old
- Did not expose to previous interventional / rehabilitation programs for his/her child.
Exclusion Criteria for mothers:
- have a diagnosis of any of psychiatric disorders
- Being absent more than three sessions in study group
Exclusion criteria for children: if they have:
- Intelligence level below 70
- Have severe deterioration
- Receive psychiatric medication
- Have multiple disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: study ( interventional ) group
this group received 8 sessions of CBT
|
through CBT sessions , the participants apply problem solving process in managing their stressors .
examining the role of cognitions, emotions, and behaviors to form cause and effect relationship of participants psychological distress
|
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NO_INTERVENTION: Control group
they will receive on intervention sessions or any education researchers makes meeting every month to answer any questions and to maintain continuity of relation with participants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mean scores of psychological distress scores among study group post intervention
Time Frame: two months
|
Change in mean scores of psychological distress
|
two months
|
|
Change in mean scores of problem solving skills inventor among study group post intervention
Time Frame: 2 months
|
Change in mean scores of problem solving skills inventory
|
2 months
|
Collaborators and Investigators
Sponsor
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
- 62
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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