Cognitive Behavioral Therapy and Problem SolvingNCT05568303
the Role of Problem Solving in Cognitive Behavioral Therapy for Mothers With Autistic Children
A study testing CBT techniques in people with Cognitive Behavioral Therapy and Problem Solving and Autism Disorders and Maternal Stress, run by Jouf University at 2 sites in 2 countries.
Trial 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 . Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Cognitive Behavioral Therapy and Problem Solving, Autism Disorders and Maternal Stress
- What is being tested?
- CBT techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2022to 1 Jan 2023
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- have a diagnosis of any of psychiatric disorders
- Being absent more than three sessions in study group
- Intelligence level below 70
- Have severe deterioration
- Receive psychiatric medication
- Have multiple disorders
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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
Read the 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
- Being tested
- CBT techniques
- Keywords
- Autism disorders, maternal stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT techniquesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| study ( interventional ) group | Experimental | this group received 8 sessions of CBT Receives: Behavioral: CBT techniques |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in mean scores of psychological distress scores among study group post intervention
Change in mean scores of psychological distress
Measured: two months
Change in mean scores of problem solving skills inventor among study group post intervention
Change in mean scores of problem solving skills inventory
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Jun 2022
- Primary completion31 Oct 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Behavioral Therapy and Problem SolvingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Mahrous AbdelAziz, Jouf University
- Investigators
- Enas M Abdelaziz, PhD, Principal investigator, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568303
- Sponsor's protocol ID
- 62
- Status last verified
- Feb 2023
- First submitted
- 1 Oct 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: based on request from principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05568303
- Acronym / sponsor ID
- 62
- Keywords
- Autism disorders, maternal stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 5 Oct 2022 (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.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study ( interventional ) group | Experimental | Behavioral: CBT techniquesthis group received 8 sessions of CBT |
| Control group | No intervention | –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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- have a diagnosis of any of psychiatric disorders
- Being absent more than three sessions in study group
- Intelligence level below 70
- Have severe deterioration
- Receive psychiatric medication
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 |
|---|---|---|
| CBT techniquesthrough 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 | Behavioural | study ( interventional ) group |
Primary outcome
Change in mean scores of psychological distress scores among study group post intervention
Time frame: two months
Change in mean scores of psychological distress
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
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 8 Feb 2023.
- Individual participant dataSharing planned: No. based on request from principle investigator
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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.
Enas M Abdelaziz, PhD principal investigator
Jouf University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT techniques in people with Cognitive Behavioral Therapy and Problem Solving and Autism Disorders and Maternal Stress, run by Jouf University at 2 sites in 2 countries.
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 5 inclusion and 6 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 8 Feb 2023. 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, Saudi Arabia. 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?
Change in mean scores of psychological distress scores among study group post intervention (time frame: two months). 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?
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 8 Feb 2023.