Attention-deficit hyperactivity disorder
Conditions
Interventions
Control (Study 1&2):None
ADHD with Emotional Dysregulation Group (Study 1&2):None
Control Group (Study 3):None
Treatment Group (Study 3):Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children
ADHD without Emotional Dysregulation Group (Study 1&2):None
Sponsors
Peking University Sixth Hospital ( Institute of Mental Health )
Eligibility
Sex/Gender
All
Age
8 Years to 16 Years
Inclusion criteria
Inclusion criteria: Study 1: ADHD with Emotional Dysregulation Group: 1. Children must meet the diagnostic criteria for Attention-Deficit/Hyperactivity Disorder (ADHD) as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). A preliminary clinical diagnosis is made based on unstructured clinical interviews conducted by attending psychiatrists or senior-level child psychiatrists with both the child and their parent(s). Subsequently, the Schedule for Affective Disorders and Schizophrenia for School-Age Children – Present and Lifetime Version (K-SADS-P/L) is administered to assess the presence of psychiatric disorders in the participants. 2. Children‘s age between 8 and 16 years old. 3. A Full-Scale IQ score of >=80 on the Chinese version of the Wechsler Intelligence Scale for Children (WISC). 4. No prior pharmacological treatment for ADHD, or discontinuation of medication for at least six months prior to participation. 5. A score of >=6 on the Emotional Lability (EL) subscale of the Conners' Parent Rating Scale (CPRS). ADHD without Emotional Dysregulation Group: The inclusion and exclusion criteria for this group are identical to those for the ADHD with emotional dysregulation group, except that participants must have a score of less than 6 on the Emotional Lability (EL) subscale of the Conners’ Parent Rating Scale (CPRS). Control Group: 1. Participants are diagnosed by attending psychiatrists or senior-level clinicians and do not meet the diagnostic criteria for ADHD. 2. Children‘s age between 8 and 16 years old. 3. No history of psychiatric medication use. 4. A Full-Scale IQ score of >=80 on the Chinese version of the Wechsler Intelligence Scale for Children (WISC). Study 2: For participants undergoing functional near-infrared spectroscopy (fNIRS) scanning, in addition to the aforementioned inclusion criteria, both the child and the parent must meet the following conditions: Right-handedness; No metallic implants within the cranial cavity. Study 3: 1.Children meeting the diagnostic criteria for Attention-Deficit/Hyperactivity Disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) are initially diagnosed through unstructured clinical interviews conducted by attending or senior child psychiatrists with both the child and their parents. The Schedule for Affective Disorders and Schizophrenia for School-Age Children – Present and Lifetime Version (K-SADS-P/L) is then administered to assess the presence of psychiatric comorbidities. Note: Participants may have current comorbid conditions such as anxiety disorders, depressive disorders, obsessive-compulsive disorder, trauma- and stressor-related disorders, eating disorders, somatic symptom and related disorders, oppositional defiant disorder, tic disorders, and others. The primary and comorbid diagnoses are determined based on a comprehensive evaluation of symptom severity and clinical presentation. 2. Children‘s age between 8 and 12 years old. 3. Diagnosis of emotional dysregulation, defined as a score of >=6 on the Emotional Lability (EL) subscale of the Conners’ Parent Rating Scale (CPRS). 4. A Full-Scale IQ score of >=80 on the Chinese version of the Wechsler Intelligence Scale for Children (WISC). 5. Patients are either medication-naïve or on a stable medication regimen, defined as maintaining the same dosage for at least one month prior to the study.
Exclusion criteria
Exclusion criteria: Study 1: ADHD with Emotional Dysregulation Group: 1. Exclusion criteria include diagnosis of bipolar disorder, psychotic disorders, organic brain diseases, autism spectrum disorder, intellectual disability, or substance dependence. 2. Exclusion criteria include severe physical illnesses such as neurological disorders, impaired consciousness, and current substance abuse or dependence. 3. Both parents are unable to participate in the study. Study 2: Exclusion criteria are the same as those in Study 1. Study 3: 1. Diagnoses of bipolar disorder, psychotic disorders, organic brain diseases, autism spectrum disorder, intellectual disability, and substance use disorders. 2. Individuals at high risk of suicide. 3. Having previously received systematic cognitive-behavioral therapy (CBT). 4. Participants with sensory impairments (e.g., hearing or vision loss) that prevent them from fully participating in the psychological treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Global Impressions – Severity of Illness scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Emotion Regulation Checklist;Difficulties in Emotion Regulation Scale;Depression Self-Rating Scale for Children;Screen for Child Anxiety Related Emotional Disorders;Parent-child inter-brain synchrony;Emotional Lability (EL) subscale of the Conners’ Parent Rating Scale (CPRS);Emotion Regulation Questionnaire for Children and Adolescents(ERQ-CA); | — |
Countries
China
Contacts
Public ContactQiujin Qian
Peking University Sixth Hospital ( Institute of Mental Health )
Outcome results
None listed