Social functioning in children and adolescents with ADHD traits: the role of Emotional Regulation, Executive functions and Social cognition as mediators: An observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- ADHD traits will be identified using DSM-5 criteria (more than 4 symptoms in either inattention or hyperactivity/impulsivity)
研究概览
简要总结
- Approval will be obtained from the Department of Scientific Committee and Institutional Ethics Committee of KMC, and the study will be registered at the Clinical Trial Registry of India.
2. Participants will be recruited after IEC clearance based on predefined inclusion and exclusion criteria, with informed consent from parents and assent from adolescents.
3. Participants meeting criteria for significant ADHD traits will undergo assessment of key study variables.
4. Parents will provide sociodemographic information and complete the SWAN ADHD and Strengths and difficulties questionnaire, and participate in an interview to assess the child’s social functioning.
5. Children and adolescents will complete the DERS-16, PEBL tests, and the Faux Pas Recognition Test to assess emotional regulation, executive function, and social cognition.
6. Data collection will follow strict ethical guidelines, with all information kept confidential.
7. Statistical analyses will be performed to explore relationships between study variables and test hypotheses.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 11.00 Day(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •ADHD traits present as measured by DSM 5 criteria, more than 4 symptoms in inattention domain and or more than 4 symptoms in hyperactivity or impulsivity domain.
- •Age of participants between 11 and 17 years and of any gender.
- •Seeking consultation under the Department of Psychiatry, KMC, Manipal.
- •Informed consent taken from parents.
- •Informed assent taken from adolescents, verbal assent from 11 to 12 years old and written assent from above 12 years old.
- •Minimum education of parents to be till primary school.
排除标准
- •Clinically diagnosed with moderate to severe mood disorders, anxiety disorders, personality disorders and psychotic spectrum disorders (as per DSM 5 TR level 1 cross cutting symptom measure for 11-17 years)
- •Clinically diagnosed with syndromal ASD, IDD using behavioural indicators of ICD
- •(all levels of severity).
- •Any acute/ chronic medical condition that will impact their current emotional state like chronic pain conditions, endocrine disorders, neurological conditions such as uncontrolled seizure disorder.
- •Refusal to assent/consent for the study.
结局指标
主要结局
ADHD traits will be identified using DSM-5 criteria (more than 4 symptoms in either inattention or hyperactivity/impulsivity)
时间窗: 18 months
次要结局
- Parents’ interview: SWAN ADHD, SDQ, and ICF Core Sets Interview
研究者
Dr Insiya Patanwala
Kasturba Medical College, MAHE, Manipal