the Role of Problem Solving in Cognitive Behavioral Therapy for Mothers With Autistic Children
Primary Purpose
Cognitive Behavioral Therapy and Problem Solving, Autism Disorders and Maternal Stress
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CBT techniques
Sponsored by
About this trial
This is an interventional other trial for Cognitive Behavioral Therapy and Problem Solving focused on measuring Autism disorders, maternal stress
Eligibility Criteria
Inclusion Criteria:
- Mothers caregivers who: (a) Have a child with autism spectrum disorders diagnosed science at least 6 months , and her/ his diagnosis done by a psychiatrist (b) have just one child with autistic disorder; (c) their ages between 20-50 years old;(d) did not expose to previous interventional / rehabilitation programs for his/her child.
Exclusion Criteria:
- 1- have a diagnosis of any of psychiatric disorders 2- Being absent more than three sessions in study group
Exclusion criteria for child: if they have :
- Intelligence level below 70
- Have severe deterioration
- Receive psychiatric medication
- Have multiple disorders
Sites / Locations
- Governmental Clinic
- Enas Mahrous Abdelaziz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
study ( interventional ) group
Control group
Arm Description
this group received 8 sessions of CBT
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
Outcomes
Primary Outcome Measures
Change in mean scores of psychological distress scores among study group post intervention
Change in mean scores of psychological distress
Change in mean scores of problem solving skills inventor among study group post intervention
Change in mean scores of problem solving skills inventory
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05568303
Brief Title
the Role of Problem Solving in Cognitive Behavioral Therapy for Mothers With Autistic Children
Official Title
The Effect of Cognitive Behavioral Therapy on Psychological Distress Among Mothers of Children With Autism Spectrum Disorders: The Role of Problem-Solving Appraisal
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jouf University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
Detailed Description
mothers of children with autistic spectrum disorders have a lots of burdens due to child symptoms its, lack of availability of services and limited resources , thus in turn lead them to become unable to face problems/stressors and to be psychological distress. CBT is an effective therapy to minimize stress, anxiety and depression. Mothers who participated in the study recruited from three governmental hospitals that has an out patients clinics specialized in autism and other developmental disorders for children at ElBehairah governate , Egypt . Based on inclusion and exclusion criteria for mothers and their children, mothers informed about the nature of the study and their benefits for participations. assessment tools will use ; depression ,anxiety and stress scale (DAS) and problem solving inventory (PSI). First assessment will occur , then randomly the participants divide into either study ( intervention) group or control group .CBT sessions will provide for study group to enhance their problem solving ability and psychological state. Second assessment (T2) will occur after finishing program sessions for all participants
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Behavioral Therapy and Problem Solving, Autism Disorders and Maternal Stress
Keywords
Autism disorders, maternal stress
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study ( interventional ) group
Arm Type
Experimental
Arm Description
this group received 8 sessions of CBT
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
CBT techniques
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in mean scores of psychological distress scores among study group post intervention
Description
Change in mean scores of psychological distress
Time Frame
two months
Title
Change in mean scores of problem solving skills inventor among study group post intervention
Description
Change in mean scores of problem solving skills inventory
Time Frame
2 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
only mothers of autistics children's involve
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enas M Abdelaziz, PhD
Organizational Affiliation
Jouf University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Governmental Clinic
City
Behera Governate
State/Province
Beera
ZIP/Postal Code
22516
Country
Egypt
Facility Name
Enas Mahrous Abdelaziz
City
Jouf
ZIP/Postal Code
00966
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
based on request from principle investigator
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the Role of Problem Solving in Cognitive Behavioral Therapy for Mothers With Autistic Children
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