Investigating the effectiveness of Cognitive-Behavioral Therapy on the improvement of the psychological symptoms of parents with Attention Deficit-Hyperactivity Disorder and measuring its effect on the outcome of their children's treatment
Investigating the effectiveness of Cognitive-Behavioral Therapy on the improvement of the psychological symptoms of parents with Attention Deficit-Hyperactivity Disorder and measuring its effect on the outcome of their children's treatment.
Design
Clinical trial with control group, with parallel groups, randomized through random numbers table, on 32 patients.
Settings and conduct
The intervention of this project will be based on cognitive-behavioral therapy focused on adult ADHD, which will consist of ten 45-minute weekly sessions, delivered individually by a trained therapist to the parent with ADHD. The sessions will be conducted online or in person at the Behravan Psychologal Clinic in Hamedan city. The variables will be assessed before the intervention begins, after the sessions end, and two months later.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Receiving a diagnosis of adult ADHD based on a diagnostic interview based on DSM-5
- Having at least one child aged 7 to 12 years with ADHD under conventional treatment
- Informed and written consent to participate in the study
Intervention groups
The intervention of this project will be based on cognitive-behavioral therapy focused on adult ADHD, which focuses on improving the psychological symptoms of parents with attention deficit hyperactivity disorder and measuring its impact on the outcome of their children's treatment. The control group will also receive cognitive-behavioral therapy in the form of weekly group sessions after the completion of the project due to ethical considerations.
Main outcome variables
Reduction in Depression, Stress and Anxiety after the intervention and two months after the intervention based on the 21_DASS questionnaire.
Improvement in symptoms of attention deficit hyperactivity disorder after the intervention and two months after the intervention based on the ASRS questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250222064814N1
Registration date:2025-03-30, 1404/01/10
Registration timing:registered_while_recruiting
Last update:2025-03-30, 1404/01/10
Update count:0
Registration date
2025-03-30, 1404/01/10
Registrant information
Name
Hasti Gerami boroujerdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3823 2588
Email address
hasti.gb@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-05-19, 1404/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of Cognitive-Behavioral Therapy on the improvement of the psychological symptoms of parents with Attention Deficit-Hyperactivity Disorder and measuring its effect on the outcome of their children's treatment
Public title
Investigating the effectiveness of Cognitive-Behavioral Therapy on the improvement of the psychological symptoms of parents with Attention Deficit-Hyperactivity Disorder and measuring its effect on the outcome of their children's treatment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Receive a diagnosis of adult ADHD based on a diagnostic interview based on DSM-5
Obtained a score higher than 50 on the Adult ADHD Self-Report Scale (ASRS) questionnaire
Having at least one child aged 7 to 12 years with ADHD under conventional treatment
Not received a diagnosis of severe mental disorders including psychotic spectrum disorders, bipolar type 1, substance use disorder, and severe personality disorders based on SCID-5
Provided informed and written consent to participate in the research
Having a minimum education of 8th grade (completion of middle school)
Not taking psychiatric medications from two months before to the end of the study
Not receiving any psychological intervention from three months before to the end of the study
Exclusion criteria:
The presence of other severe mental disorders such as other neurodevelopmental disorders, mood disorders, etc.
History of severe drug or alcohol abuse.
The presence of significant cognitive disorders, intellectual disability or below-average IQ
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method.
Individual randomization unit.
Randomization tool: Random number table
Allocation concealment: through a third person; Other than the researcher, it has been done to a void bias
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah Medical Science Central Building, Shahid Beheshti Blvd, Kermanshah.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-10-27, 1403/08/06
Ethics committee reference number
IR.KUMS.MED.REC.1403.331
Health conditions studied
1
Description of health condition studied
Attention-Deficit, Hyperactivity Disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
Reducing the score of the stress scale based on the Depression, Anxiety and Stress Scale - 21 Items questionnaire
Timepoint
Measurement of stress scale in the Depression, Anxiety and Stress Scale - 21 Items questionnaire at the beginning of the study, immediately after the intervention, and two months after the intervention.
Method of measurement
The Depression, Anxiety and Stress Scale - 21 Items questionnaire
2
Description
Reducing the score of the depression scale based on the Depression, Anxiety and Stress Scale - 21 Items questionnaire
Timepoint
Measurement of depression scale in the Depression, Anxiety and Stress Scale - 21 Items questionnaire at the beginning of the study, immediately after the intervention, and two months after the intervention.
Method of measurement
The Depression, Anxiety and Stress Scale - 21 Items questionnaire
3
Description
Reducing the score of the anxiety scale based on the Depression, Anxiety and Stress Scale - 21 Items questionnaire
Timepoint
Measurement of anxiety scale in the Depression, Anxiety and Stress Scale - 21 Items questionnaire at the beginning of the study, immediately after the intervention, and two months after the intervention.
Method of measurement
The Depression, Anxiety and Stress Scale - 21 Items questionnaire
4
Description
Improvement of symptoms of attention deficit hyperactivity disorder based on the Adult ADHD Self-Report Scale questionnaire
Timepoint
Measuring the score obtained in the Adult ADHD Self-Report Scale questionnaire at the beginning of the study and immediately after the intervention and two months after the intervention.
Method of measurement
The Adult ADHD Self-Report Scale questionnaire
Secondary outcomes
1
Description
Improving the quality of parent relationships based on the Quality of Relationship Inventory questionnaire
Timepoint
Measuring the quality of parental relationships using the Quality of Relationship Inventory questionnaire at the beginning of the study, immediately after the intervention, and two months after the intervention.
Method of measurement
The Quality of Relationship Inventory questionnaire
2
Description
Improving symptoms of attention deficit hyperactivity disorder in children based on the Conners ADHD rating scale questionnaire
Timepoint
Measurement of children's attention deficit hyperactivity disorder symptoms based on the Conners ADHD rating scale at the beginning of the study, immediately after the intervention, and two months after the intervention.
Method of measurement
The Conners ADHD rating scale questionnaire
3
Description
Improvement in children's academic performance based on the assessment of their academic average.
Timepoint
Improvement in children's academic performance at the beginning of the study and two months after the intervention based on their academic grade point average
Method of measurement
Assessment of academic average.
Intervention groups
1
Description
Intervention group: The intervention of this plan will be based on cognitive-behavioral therapy focused on adult ADHD, which will consist of eight 45-minute weekly sessions (in person or online, as appropriate) and will be implemented individually by a trained therapist for the parent with ADHD.
Category
N/A
2
Description
Control group: The control group will also receive cognitive behavioral therapy in the form of weekly group sessions after the completion of the project due to ethical considerations.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Mahdi Nobakht's neuropsychiatric clinic
Full name of responsible person
Mehdi Nobakht
Street address
Doctors building NO.1, Bo Ali St, Aramgah Bo Ali Square, Hamadan.
City
Hamedan
Province
Hamadan
Postal code
6516684515
Phone
+98 81 3253 3844
Email
hasti.gb@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Jalili, Sirous
Street address
Deputy Research and Technology Department, Building No. 2 of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah.
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
research_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Gerami Boroujerdi,Hasti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 398, Saidieh Residential Complex, Saidieh St, Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6516953996
Phone
+98 81 3823 2588
Email
hasti.gb@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammadian, Yokhabe
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
South Second House,Third Alley, South Golestan St., Hafez Sq., Rudaki Cross., Kermanshah Town
City
Kermanshah
Province
Kermanshah
Postal code
4855467148
Phone
+98 918 802 6031
Email
yokhabe@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Gerami Boroujerdi,Hasti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 398, Saidieh Residential Complex, Saidieh St, Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6516953996
Phone
+98 81 3823 2588
Email
hasti.gb@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available