Attention Deficit Hyperactivity DisorderNCT06624527
Cognitive Behavior Therapy for Children With Attention Deficit Hyperactivity Disorder
A study testing Psychoeducation based on Cognitive Behavioral Therapy in people with Attention Deficit Hyperactivity Disorder, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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 child's quality of life, anxiety and… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Psychoeducation based on Cognitive Behavioral Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2023to 3 Jan 2025
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who are diagnosed with ADHD according to DSM-V diagnostic criteria,
- Do not have another psychiatric disorder not specific to ADHD,
- Do not have a mental disability,
- Do not seek pharmacological treatment,
- Are between the ages of 8-16,
- Can read and write,
- Can communicate and cooperate,
- Agree to participate in the study (parents and/or themselves) are included in the study.
Who cannot join
- Those with another psychiatric disorder not specific to ADHD,
- Those with mental retardation,
- Those receiving pharmacological treatment,
- Those between the ages of 8-16,
- Those who cannot read or write,
- Those who request to withdraw from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital
Kahramanmaraş, OnikiŞubat, 46500
About this study
Official title: The Effect of Cognitive Behavior Therapy-Based Psychoeducation Given to Children With Attention Deficit Hyperactivity Disorder on Children's Quality of Life, Anxiety and Depression
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 child's 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.
Read the detailed description
- Research Model This study was planned as a pre-test/post-test, single blind randomized controlled experimental design.
- Hypotheses of the Study Hypothesis 1 (H1): Does cognitive behavior therapy-based psycho-education given to children with ADHD affect children's quality of life? Hypothesis 2 (H2): Does cognitive behavior therapy-based psycho-education given to children with ADHD affect children's anxiety and depression levels?
- 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.
- Ethical Aspects of the Study
- With the decision numbered 2022/29 of Hasan Kalyoncu University Health Sciences Institute Board of Directors, this research was accepted as a doctoral thesis subject on 19.12.2022.
- Ethics committee permission was obtained from Hasan Kalyoncu University Faculty of Health Sciences Non-Interventional Research Ethics Committee with the decision numbered 2023/31 dated 31.01.2023.
- 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 22.09.2023.
- 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.
- 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 3.1.9.7 program, alpha: 0.05, effect size 0.8, 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.
- Sample Inclusion Criteria Criteria for children's 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 and/or 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 child's 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.
- Data Collection Tools In the collection of data, the "Personal Information Form" created in line with the literature, the "Revised Children's 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. 7.1 Descriptive Characteristics Form The "Personal Information Form" prepared by the researcher included 6 questions for the child/adolescent 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. 7.2 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, Cronbach's alpha coefficient was found to be 0.93. 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 person's 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 Cronbach's alpha coefficient was found to be 0.93. Validity assessment was made by looking at construct validity and clinical validity. In this study, Cronbach's alpha coefficient was found to be 0.94. 7.3. Anxiety and Depression Scale in Children-Child/Parent 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 3,14,24,26,28,34,36,39,41. items), Generalized Anxiety Disorder (items 1,13,22,27,35,37) and Major Depressive Disorder (items 2,6,11,15,19,21,25,29,40,47). 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 Cronbach's alpha coefficients of the sub-dimensions in the original form of the scale are as follows: 0.82 for Social Phobia, 0.79 for Panic Disorder, 0.76 for Separation Anxiety Disorder, 0.76 for Major Depressive Disorder, 0.73 for Obsessive Compulsive Disorder and 0.77 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 (0=never, 1=sometimes, 2=often and 3=always). The six-factor sub-dimensions of the scale were confirmed by confirmatory factor analysis and the internal consistency of the Turkish form was strong/excellent 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, Cronbach's alpha coefficient was 0.92. After the child and parent scales are completed, the child's 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.
- 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.
- Data Collection The data were collected by face-to-face interviews with children/adolescents diagnosed with ADHD and their parents between September 25, 2023 and August 30, 2024 at Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital/Child 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 child/adolescent diagnosed with ADHD and the family were informed about the study by the specialist/assistant 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, children/adolescents 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 child/adolescent and his/her 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.
- 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-Child/Parent Form and Quality of Life Scale) data were collected. At the doctor's 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Psychoeducation based on Cognitive Behavioral Therapy
- Keywords
- Child,, Attention deficit Hyperactivity disorder, Cognitive Behavioral Therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation based on Cognitive Behavioral TherapyOther
A psycho-educational application based on Cognitive Behavior Therapy consisting of a total of 8 sessions prepared by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No intervention will be made to the control group. This group will be given a first test using the scales specified in the data collection, and a final test will be given 30 days later using the same scales. |
| Intervention group | Experimental | After the first test application with the scales specified in the data collection, 8 sessions of Cognitive Behavior Therapy-based psycho-education sessions will be applied to the intervention group. At the end of the 8 sessions (which will last 30 days on average), a final test will be applied. Receives: Other: Psychoeducation based on Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psycho-educational application based on Cognitive Behavioral Therapy
This study will investigate how cognitive behavior-based psychoeducation given to children diagnosed with Attention Deficit Hyperactivity Disorder will affect the child's quality of life, anxiety, and depression.
Two scales will be used to measure the results of the interventions made in the research. These scales are:
1-Child Anxiety and Depression Scale; consists of 47 items.
2.Quality of life scale for children consists of 23 items.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start25 Sep 2023
- Primary completion15 Dec 2024
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was planned as a pre-test/post-test, single blind randomized controlled experimental design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vedat ARGIN, Hasan Kalyoncu University
- Investigators
- vedat Argın, lecturer, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624527
- Sponsor's protocol ID
- VA_001
- Other IDs
- 323S282
- Status last verified
- Mar 2025
- First submitted
- 26 Sep 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Argin V, Cigdem Z, Altun H, Doganer A. The effects of cognitive behavioral therapy-based psychoeducation on quality of life, anxiety, and depression in children with attention deficit hyperactivity disorder. BMC Psychol. 2026 Feb 7;14(1):342. doi: 10.1186/s40359-026-04110-7.
PubMed 41652519
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Behavior Therapy-Based Psychoeducation Given to Children With Attention Deficit Hyperactivity Disorder on Children's Quality of Life, Anxiety and Depression
- ClinicalTrials.gov ID
- NCT06624527
- Acronym / sponsor ID
- VA_001
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Child,, Attention deficit Hyperactivity disorder, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 3 Oct 2024 (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.
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 child's 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.
Detailed description
- Research Model This study was planned as a pre-test/post-test, single blind randomized controlled experimental design.
- Hypotheses of the Study Hypothesis 1 (H1): Does cognitive behavior therapy-based psycho-education given to children with ADHD affect children's quality of life? Hypothesis 2 (H2): Does cognitive behavior therapy-based psycho-education given to children with ADHD affect children's anxiety and depression levels?
- 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.
- Ethical Aspects of the Study
- With the decision numbered 2022/29 of Hasan Kalyoncu University Health Sciences Institute Board of Directors, this research was accepted as a doctoral thesis subject on 19.12.2022.
- Ethics committee permission was obtained from Hasan Kalyoncu University Faculty of Health Sciences Non-Interventional Research Ethics Committee with the decision numbered 2023/31 dated 31.01.2023.
- 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 22.09.2023.
- 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.
- 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 3.1.9.7 program, alpha: 0.05, effect size 0.8, 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.
- Sample Inclusion Criteria Criteria for children's 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 and/or 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 child's 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.
- Data Collection Tools In the collection of data, the "Personal Information Form" created in line with the literature, the "Revised Children's 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. 7.1 Descriptive Characteristics Form The "Personal Information Form" prepared by the researcher included 6 questions for the child/adolescent 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. 7.2 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, Cronbach's alpha coefficient was found to be 0.93. 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 person's 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 Cronbach's alpha coefficient was found to be 0.93. Validity assessment was made by looking at construct validity and clinical validity. In this study, Cronbach's alpha coefficient was found to be 0.94. 7.3. Anxiety and Depression Scale in Children-Child/Parent 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 3,14,24,26,28,34,36,39,41. items), Generalized Anxiety Disorder (items 1,13,22,27,35,37) and Major Depressive Disorder (items 2,6,11,15,19,21,25,29,40,47). 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 Cronbach's alpha coefficients of the sub-dimensions in the original form of the scale are as follows: 0.82 for Social Phobia, 0.79 for Panic Disorder, 0.76 for Separation Anxiety Disorder, 0.76 for Major Depressive Disorder, 0.73 for Obsessive Compulsive Disorder and 0.77 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 (0=never, 1=sometimes, 2=often and 3=always). The six-factor sub-dimensions of the scale were confirmed by confirmatory factor analysis and the internal consistency of the Turkish form was strong/excellent 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, Cronbach's alpha coefficient was 0.92. After the child and parent scales are completed, the child's 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.
- 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.
- Data Collection The data were collected by face-to-face interviews with children/adolescents diagnosed with ADHD and their parents between September 25, 2023 and August 30, 2024 at Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital/Child 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 child/adolescent diagnosed with ADHD and the family were informed about the study by the specialist/assistant 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, children/adolescents 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 child/adolescent and his/her 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.
- 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-Child/Parent Form and Quality of Life Scale) data were collected. At the doctor's 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was planned as a pre-test/post-test, single blind randomized controlled experimental design
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention will be made to the control group. This group will be given a first test using the scales specified in the data collection, and a final test will be given 30 days later using the same scales. |
| Intervention group | Experimental | Other: Psychoeducation based on Cognitive Behavioral TherapyAfter the first test application with the scales specified in the data collection, 8 sessions of Cognitive Behavior Therapy-based psycho-education sessions will be applied to the intervention group. At the end of the 8 sessions (which will last 30 days on average), a final test will be applied. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children who are diagnosed with ADHD according to DSM-V diagnostic criteria,
- Do not have another psychiatric disorder not specific to ADHD,
- Do not have a mental disability,
- Do not seek pharmacological treatment,
- Are between the ages of 8-16,
Key exclusion criteria (6 listed)
- Those with another psychiatric disorder not specific to ADHD,
- Those with mental retardation,
- Those receiving pharmacological treatment,
- Those between the ages of 8-16,
- Those who cannot read or write,
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 |
|---|---|---|
| Psychoeducation based on Cognitive Behavioral TherapyA psycho-educational application based on Cognitive Behavior Therapy consisting of a total of 8 sessions prepared by the researcher. | Other | Intervention group |
Primary outcome
Psycho-educational application based on Cognitive Behavioral Therapy
Time frame: 4 weeks
This study will investigate how cognitive behavior-based psychoeducation given to children diagnosed with Attention Deficit Hyperactivity Disorder will affect the child's quality of life, anxiety, and depression. Two scales will be used to measure the results of the interventions made in the research. These scales are: 1-Child Anxiety and Depression Scale; consists of 47 items. 2.Quality of life scale for children consists of 23 items.
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 12 Mar 2025.
- Derived from this study: PubMed 41652519Argin V, Cigdem Z, Altun H, Doganer A. The effects of cognitive behavioral therapy-based psychoeducation on quality of life, anxiety, and depression in children with attention deficit hyperactivity disorder. BMC Psychol. 2026 Feb 7;14(1):342. doi: 10.1186/s40359-026-04110-7.
- Individual participant dataSharing planned: No
Related trials for Attention Deficit Hyperactivity Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
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.
vedat Argın, lecturer principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation based on Cognitive Behavioral Therapy in people with Attention Deficit Hyperactivity Disorder, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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 8 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Psycho-educational application based on Cognitive Behavioral Therapy (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06624527, which also lists 1 linked publication.
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 12 Mar 2025.