Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624527
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Cognitive Behavior Therapy for Children With Attention Deficit Hyperactivity Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Cognitive Behavior Therapy-Based Psychoeducation Given to Children With Attention Deficit Hyperactivity Disorder on Childrens Quality of Life Anxiety and Depression
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was planned to determine the changes that cognitive behavior therapy-based psycho-education against the negativities brought by the disease in the long term of children diagnosed with Attention Deficit Hyperactivity Disorder will create changes in the childs quality of life anxiety and depression status and disease symptoms
As a result of this study if cognitive behavior-based psycho-education has a positive effect on anxiety depression and quality of life of children with Attention Deficit Hyperactivity Disorder it is thought to contribute positively to the development of the disease for the sick child and parents by organizing psycho-education programs with the training to be given to child health nurses
As a result of this study if cognitive behavior-based psycho-education has a positive effect on anxiety depression and quality of life of children with Attention Deficit Hyperactivity Disorder it is thought to contribute positively to the development of the disease for the sick child and parents by organizing psycho-education programs with the training to be given to child health nurses
Detailed Description:
1 Research Model This study was planned as a pre-testpost-test single blind randomized controlled experimental design
2 Hypotheses of the Study Hypothesis 1 H1 Does cognitive behavior therapy-based psycho-education given to children with ADHD affect childrens quality of life Hypothesis 2 H2 Does cognitive behavior therapy-based psycho-education given to children with ADHD affect childrens anxiety and depression levels
3 Place and Time of the Study This study was conducted at Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital Department of Child and Adolescent Psychiatry between September 25 2023 and December 30 2024
4 Ethical Aspects of the Study
With the decision numbered 202229 of Hasan Kalyoncu University Health Sciences Institute Board of Directors this research was accepted as a doctoral thesis subject on 19122022
Ethics committee permission was obtained from Hasan Kalyoncu University Faculty of Health Sciences Non-Interventional Research Ethics Committee with the decision numbered 202331 dated 31012023
Written institutional permission was obtained from Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital where the research will be conducted with decision number 24523 dated 22092023
Within the scope of the research CBT Practitioner Training in Children and Adolescents was received from Fatih Sultan Mehmet University Barcode No UN_041054323475554869027
The research was supported by the Scientific and Technical Research Council of Turkey 1002- A Rapid Support Project No 323S232
For the scales used in the study permission was obtained from the scale developers via e-mail
Within the scope of the study all participants who agreed to participate in the study were given preliminary information about the study
Confidentiality of patients names and information was taken as a basis
No fee was requested from the patients to participate in the study and no additional payment was made to the patients participating in the study
Participation in the study was voluntary
5 Population and Sample of the Study The population of the study consisted of all children with ADHD newly diagnosed children and children who were followed up and their parents who applied to the outpatient clinic
The sample of the study consisted of patients who met the inclusion criteria and agreed to participate in the study Before starting the study to determine the sample size reference results were evaluated based on literature reviews In line with the data entered into the G Power 3197 program alpha 005 effect size 08 confidence interval 95 the number of participants to be included in the study for each group was calculated as at least 35 children and 35 parents for the control and intervention groups separately for a total of 70 control and 70 intervention groups Considering the losses during the study the study was started with groups of 40 participants each
6 Sample Inclusion Criteria Criteria for childrens participation in the study
Diagnosed with ADHD according to DSM-V diagnostic criteria
No other comorbid disease accompanying ADHD
No mental disability
Not receiving pharmacological treatment
8-16 years old
Can read and write
Communication and cooperation
Children who agree to participate in the study their parents andor themselves will be included in the study
Criteria for parental participation in the study
Allowing their child to participate in the study
Living with her child
the childs natural parent
No hearing-speech impairment
Without a diagnosed and treated mental illness
Mothers who can communicate and are open to cooperation will be included in the study
7 Data Collection Tools In the collection of data the Personal Information Form created in line with the literature the Revised Childrens Anxiety and Depression Scale filled out separately by the child and the parent to determine the anxiety and depression levels of children and the Quality of Life Scale for Children to determine the quality of life of children were used
71 Descriptive Characteristics Form The Personal Information Form prepared by the researcher included 6 questions for the childadolescent and 14 questions for the parents to determine the sociodemographic variables age gender education level occupation marital status monthly income school achievement and information about the disease
72 Quality of Life Scale in Children It is a scale developed by Varni et al in 1999 as a result of a 15-year study to measure the physical and psychosocial experiences of children between the ages of 2-18 independent of illness and their health-related quality of life Physical health emotional and social functioning areas and school functioning areas which are the characteristics of the state of health defined by the World Health Organization are questioned in the scale The scale consists of 23 items in total and is prepared as a four-point Likert scale In the reliability assessment of the scale Cronbachs alpha coefficient was found to be 093 Item scores are evaluated between 0 and 100 If the answer to the question is marked as never it gets 100 points If it is marked as rarely it gets 75 points if it is marked as sometimes it gets 50 points if it is marked as frequently it gets 25 points and if it is marked as almost always it gets 0 points A persons health-related quality of life is considered to be more positive the higher the total score
Scale scoring is carried out in three different areas Scale Total Score SCS Physical Health Total Score PHTS and Psychosocial Health Total Score PSTP which assess emotional social and school functioning
The validity and reliability study of the scale in Turkish was conducted by Üneri for 2-7 age groups and Çakın Memik for 8-18 age groups Internal consistency study was conducted for reliability assessment and Cronbachs alpha coefficient was found to be 093 Validity assessment was made by looking at construct validity and clinical validity In this study Cronbachs alpha coefficient was found to be 094
73 Anxiety and Depression Scale in Children-ChildParent Form The Revised Anxiety and Depression Scale RADS is a clinical symptom screening scale developed to detect DSM-IV based depression and anxiety disorders in children and adolescents
It was developed by Chorpita et al in 2000 and has a parent and child form that can be completed independently Consisting of 47 items the child and parent scale forms consist of 6 sub-dimensions in total
These dimensions are Separation Anxiety items 5 9 17 18 33 45 46 Social Phobia items 4 7 8 12 20 30 32 38 43 Obsessive Compulsive Disorder items 10 16 23 31 42 44 Panic Disorder items 31424262834363941 items Generalized Anxiety Disorder items 11322273537 and Major Depressive Disorder items 261115192125294047 In the scale score calculation a total of eight scores can be calculated These scores represent the total scores of the scale also known as the six sub-dimensions anxiety total score and anxiety-depression total score
To calculate the total anxiety score items for social phobia panic disorder separation anxiety disorder generalized anxiety disorder and obsessive-compulsive disorder are summed For the total anxiety-depression score the major depressive disorder score is added
The Cronbachs alpha coefficients of the sub-dimensions in the original form of the scale are as follows 082 for Social Phobia 079 for Panic Disorder 076 for Separation Anxiety Disorder 076 for Major Depressive Disorder 073 for Obsessive Compulsive Disorder and 077 for Generalized Anxiety Disorder
In the study conducted by Görmez et al in 2017 the scale was adapted to Turkish and validity and reliability studies were conducted The Turkish version of the scale consists of 47 items and has a four-point Likert scale 0never 1sometimes 2often and 3always
The six-factor sub-dimensions of the scale were confirmed by confirmatory factor analysis and the internal consistency of the Turkish form was strongexcellent with a Cronbach alpha score of 95 The sub-dimensions ranged from 75 to 86 There is sufficient evidence to prove that it is a valid scale for use with Turkish children and adolescents In this study Cronbachs alpha coefficient was 092
After the child and parent scales are completed the childs gender and age are recorded in the scoring table and T and Raw scores are determined RCADS-Parent scoring was done using the Excel program version 32 Any sub or total scale T score scores of 65 and above indicate borderline clinical threshold while scores of 70 and above are considered clinical threshold
8 Variables of the Study
Dependent Variables of the Study
Revised Child Anxiety and Depression Scale - Child Form Revised Child Anxiety and Depression Scale - Parent Form Quality of Life Scale for Children
Independent Variables of the Study
The independent variable of the study was the CBT-based psycho-education program
9 Data Collection
The data were collected by face-to-face interviews with childrenadolescents diagnosed with ADHD and their parents between September 25 2023 and August 30 2024 at Kahramanmaraş Sütçü İmam University Health Practice and Research HospitalChild and Adolescent Psychiatry Department A suitable room in the Child and Adolescent Psychiatry Outpatient Clinic was prepared for data collection and parents were contacted by phone in advance for appointments and appropriate dates and times were determined
Before the data collection started the childadolescent diagnosed with ADHD and the family were informed about the study by the specialistassistant physician working in the Child and Adolescent Psychiatry outpatient clinic who met the inclusion criteria and the contact information of the parents who agreed to participate in the study was recorded For the sample group childrenadolescents and parents who met the study criteria were ranked in consecutive order by the researcher
The sample group which was determined in consecutive order was randomly divided into two groups with odd numbers being the intervention group and even numbers being the control group and the participants who volunteered to participate in the study were informed about the study and verbal consent was obtained
A pre-test was administered to the control group when the first interview was conducted When they came to the hospital for a follow-up visit 30-40 days later a post-test was administered The intervention group was contacted by phone beforehand and the purpose and method of the study was explained again and the date and time for the first interview was determined A total of 8 sessions were held with the childadolescent and hisher parent with the individual face-to-face interview technique during the appointment hours determined on weekdays one session per week After each session the date and time of the next session was determined with the parents in the intervention group Each session lasted 40-45 minutes on average With the intervention group a pre-test was administered in the first session and a post-test was administered in the last session In both groups data collection tools were filled in by the researcher This process took 20-25 minutes except for the session time Anxiety and Depression Scale-Parent Form was filled out based on the mother when both parents were present with the child during the session
10 Investigative Nursing Initiative
Before starting the study the researcher completed the training program called CBT Practitioner Training in Children and Adolescents Certificate No UN_041054323475554869027 from Fatih Sultan Mehmet University Continuing Education Center Appendix CBT-based psychoeducation booklet prepared by the researcher was used in the sessions
In the first interview with the children and parents who participated in the study and who were in the intervention group the first test application Personal Information Form Revised Anxiety and Depression Scale-ChildParent Form and Quality of Life Scale data were collected At the doctors visit 30-40 days later the post-test was administered No nursing intervention was applied to the control group other than the pre-test post-test application
After the first test was performed in the first session with the patients in the intervention group information about ADHD was given by giving a booklet prepared for parents in the first session dheb book appendix Parents were given homework assignments in the psychoeducation booklet prepared for children and adolescents to be included in the sessions themselves and their applications within the session
2 Hypotheses of the Study Hypothesis 1 H1 Does cognitive behavior therapy-based psycho-education given to children with ADHD affect childrens quality of life Hypothesis 2 H2 Does cognitive behavior therapy-based psycho-education given to children with ADHD affect childrens anxiety and depression levels
3 Place and Time of the Study This study was conducted at Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital Department of Child and Adolescent Psychiatry between September 25 2023 and December 30 2024
4 Ethical Aspects of the Study
With the decision numbered 202229 of Hasan Kalyoncu University Health Sciences Institute Board of Directors this research was accepted as a doctoral thesis subject on 19122022
Ethics committee permission was obtained from Hasan Kalyoncu University Faculty of Health Sciences Non-Interventional Research Ethics Committee with the decision numbered 202331 dated 31012023
Written institutional permission was obtained from Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital where the research will be conducted with decision number 24523 dated 22092023
Within the scope of the research CBT Practitioner Training in Children and Adolescents was received from Fatih Sultan Mehmet University Barcode No UN_041054323475554869027
The research was supported by the Scientific and Technical Research Council of Turkey 1002- A Rapid Support Project No 323S232
For the scales used in the study permission was obtained from the scale developers via e-mail
Within the scope of the study all participants who agreed to participate in the study were given preliminary information about the study
Confidentiality of patients names and information was taken as a basis
No fee was requested from the patients to participate in the study and no additional payment was made to the patients participating in the study
Participation in the study was voluntary
5 Population and Sample of the Study The population of the study consisted of all children with ADHD newly diagnosed children and children who were followed up and their parents who applied to the outpatient clinic
The sample of the study consisted of patients who met the inclusion criteria and agreed to participate in the study Before starting the study to determine the sample size reference results were evaluated based on literature reviews In line with the data entered into the G Power 3197 program alpha 005 effect size 08 confidence interval 95 the number of participants to be included in the study for each group was calculated as at least 35 children and 35 parents for the control and intervention groups separately for a total of 70 control and 70 intervention groups Considering the losses during the study the study was started with groups of 40 participants each
6 Sample Inclusion Criteria Criteria for childrens participation in the study
Diagnosed with ADHD according to DSM-V diagnostic criteria
No other comorbid disease accompanying ADHD
No mental disability
Not receiving pharmacological treatment
8-16 years old
Can read and write
Communication and cooperation
Children who agree to participate in the study their parents andor themselves will be included in the study
Criteria for parental participation in the study
Allowing their child to participate in the study
Living with her child
the childs natural parent
No hearing-speech impairment
Without a diagnosed and treated mental illness
Mothers who can communicate and are open to cooperation will be included in the study
7 Data Collection Tools In the collection of data the Personal Information Form created in line with the literature the Revised Childrens Anxiety and Depression Scale filled out separately by the child and the parent to determine the anxiety and depression levels of children and the Quality of Life Scale for Children to determine the quality of life of children were used
71 Descriptive Characteristics Form The Personal Information Form prepared by the researcher included 6 questions for the childadolescent and 14 questions for the parents to determine the sociodemographic variables age gender education level occupation marital status monthly income school achievement and information about the disease
72 Quality of Life Scale in Children It is a scale developed by Varni et al in 1999 as a result of a 15-year study to measure the physical and psychosocial experiences of children between the ages of 2-18 independent of illness and their health-related quality of life Physical health emotional and social functioning areas and school functioning areas which are the characteristics of the state of health defined by the World Health Organization are questioned in the scale The scale consists of 23 items in total and is prepared as a four-point Likert scale In the reliability assessment of the scale Cronbachs alpha coefficient was found to be 093 Item scores are evaluated between 0 and 100 If the answer to the question is marked as never it gets 100 points If it is marked as rarely it gets 75 points if it is marked as sometimes it gets 50 points if it is marked as frequently it gets 25 points and if it is marked as almost always it gets 0 points A persons health-related quality of life is considered to be more positive the higher the total score
Scale scoring is carried out in three different areas Scale Total Score SCS Physical Health Total Score PHTS and Psychosocial Health Total Score PSTP which assess emotional social and school functioning
The validity and reliability study of the scale in Turkish was conducted by Üneri for 2-7 age groups and Çakın Memik for 8-18 age groups Internal consistency study was conducted for reliability assessment and Cronbachs alpha coefficient was found to be 093 Validity assessment was made by looking at construct validity and clinical validity In this study Cronbachs alpha coefficient was found to be 094
73 Anxiety and Depression Scale in Children-ChildParent Form The Revised Anxiety and Depression Scale RADS is a clinical symptom screening scale developed to detect DSM-IV based depression and anxiety disorders in children and adolescents
It was developed by Chorpita et al in 2000 and has a parent and child form that can be completed independently Consisting of 47 items the child and parent scale forms consist of 6 sub-dimensions in total
These dimensions are Separation Anxiety items 5 9 17 18 33 45 46 Social Phobia items 4 7 8 12 20 30 32 38 43 Obsessive Compulsive Disorder items 10 16 23 31 42 44 Panic Disorder items 31424262834363941 items Generalized Anxiety Disorder items 11322273537 and Major Depressive Disorder items 261115192125294047 In the scale score calculation a total of eight scores can be calculated These scores represent the total scores of the scale also known as the six sub-dimensions anxiety total score and anxiety-depression total score
To calculate the total anxiety score items for social phobia panic disorder separation anxiety disorder generalized anxiety disorder and obsessive-compulsive disorder are summed For the total anxiety-depression score the major depressive disorder score is added
The Cronbachs alpha coefficients of the sub-dimensions in the original form of the scale are as follows 082 for Social Phobia 079 for Panic Disorder 076 for Separation Anxiety Disorder 076 for Major Depressive Disorder 073 for Obsessive Compulsive Disorder and 077 for Generalized Anxiety Disorder
In the study conducted by Görmez et al in 2017 the scale was adapted to Turkish and validity and reliability studies were conducted The Turkish version of the scale consists of 47 items and has a four-point Likert scale 0never 1sometimes 2often and 3always
The six-factor sub-dimensions of the scale were confirmed by confirmatory factor analysis and the internal consistency of the Turkish form was strongexcellent with a Cronbach alpha score of 95 The sub-dimensions ranged from 75 to 86 There is sufficient evidence to prove that it is a valid scale for use with Turkish children and adolescents In this study Cronbachs alpha coefficient was 092
After the child and parent scales are completed the childs gender and age are recorded in the scoring table and T and Raw scores are determined RCADS-Parent scoring was done using the Excel program version 32 Any sub or total scale T score scores of 65 and above indicate borderline clinical threshold while scores of 70 and above are considered clinical threshold
8 Variables of the Study
Dependent Variables of the Study
Revised Child Anxiety and Depression Scale - Child Form Revised Child Anxiety and Depression Scale - Parent Form Quality of Life Scale for Children
Independent Variables of the Study
The independent variable of the study was the CBT-based psycho-education program
9 Data Collection
The data were collected by face-to-face interviews with childrenadolescents diagnosed with ADHD and their parents between September 25 2023 and August 30 2024 at Kahramanmaraş Sütçü İmam University Health Practice and Research HospitalChild and Adolescent Psychiatry Department A suitable room in the Child and Adolescent Psychiatry Outpatient Clinic was prepared for data collection and parents were contacted by phone in advance for appointments and appropriate dates and times were determined
Before the data collection started the childadolescent diagnosed with ADHD and the family were informed about the study by the specialistassistant physician working in the Child and Adolescent Psychiatry outpatient clinic who met the inclusion criteria and the contact information of the parents who agreed to participate in the study was recorded For the sample group childrenadolescents and parents who met the study criteria were ranked in consecutive order by the researcher
The sample group which was determined in consecutive order was randomly divided into two groups with odd numbers being the intervention group and even numbers being the control group and the participants who volunteered to participate in the study were informed about the study and verbal consent was obtained
A pre-test was administered to the control group when the first interview was conducted When they came to the hospital for a follow-up visit 30-40 days later a post-test was administered The intervention group was contacted by phone beforehand and the purpose and method of the study was explained again and the date and time for the first interview was determined A total of 8 sessions were held with the childadolescent and hisher parent with the individual face-to-face interview technique during the appointment hours determined on weekdays one session per week After each session the date and time of the next session was determined with the parents in the intervention group Each session lasted 40-45 minutes on average With the intervention group a pre-test was administered in the first session and a post-test was administered in the last session In both groups data collection tools were filled in by the researcher This process took 20-25 minutes except for the session time Anxiety and Depression Scale-Parent Form was filled out based on the mother when both parents were present with the child during the session
10 Investigative Nursing Initiative
Before starting the study the researcher completed the training program called CBT Practitioner Training in Children and Adolescents Certificate No UN_041054323475554869027 from Fatih Sultan Mehmet University Continuing Education Center Appendix CBT-based psychoeducation booklet prepared by the researcher was used in the sessions
In the first interview with the children and parents who participated in the study and who were in the intervention group the first test application Personal Information Form Revised Anxiety and Depression Scale-ChildParent Form and Quality of Life Scale data were collected At the doctors visit 30-40 days later the post-test was administered No nursing intervention was applied to the control group other than the pre-test post-test application
After the first test was performed in the first session with the patients in the intervention group information about ADHD was given by giving a booklet prepared for parents in the first session dheb book appendix Parents were given homework assignments in the psychoeducation booklet prepared for children and adolescents to be included in the sessions themselves and their applications within the session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None