Treatment of Emotional Disorders in Spanish Children: Efficacy of Super Skills for Life Transdiagnostic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Diagnosis based on DSM-5 criteria at 1 year
研究概览
简要总结
Super Skills for Life (SSL) is a transdiagnostic cognitive-behavioral protocol developed for children aged 6 to 12 with anxiety and comorbid problems (e.g., depression, low self-esteem, and lack of social skills).
SSL consists of eight sessions targeting common risk factors for internalizing disorders such as cognitive distortions, avoidance, emotional management, low self-esteem, social skills deficits and coping strategies.
The aim of the study is to investigate the short- and long-term effects of SSL on internalizing and externalizing symptoms in Spanish children attending the Child and Adolescent Mental Health Services.
详细描述
To validate eligibility children and their parents will complete several psychometrically robust and developmentally appropriate measures. Participants meeting inclusion criteria will be randomly allocated to the conditions of the intervention group and the wait-list control group.
Parents and children from both groups will complete the same measures at baseline and post-treatment.
Parents and children from SSL will also complete these measures at 3 months follow-up, 6 months follow-up and 12 months follow-up.
The investigators will assess the benefits from pre-test to post-test in children participating in SSL compared to those in a wait-list control group on DSM-5 diagnostic remission, anxiety symptoms, anxiety impairment, depressive symptoms, self-esteem, behavioral problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.
The investigators will also assess these variables in the intervention group at 3 months, 6 months, and 12 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 8 -
- •Primary diagnosis of an anxiety disorder, a depressive disorder, and/or trauma- or stress-related disorder with anxiety and/or depressive symptoms.
- •Speaking, reading, writing and understanding Spanish.
- •Caregivers agree to attend all sessions and to receive feedback and suggestions.
排除标准
- •Intellectual disability, behavioral symptoms, or autism spectrum symptoms whose severity precluded continued treatment.
- •The child is at the same time in psychological treatment.
- •The child is not on a stable dose of medication for at least 1 month prior to baseline assessment.
结局指标
主要结局
Diagnosis based on DSM-5 criteria at 1 year
时间窗: 1 year after the intervention
Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification.
Change from baseline depression symptoms to immediately after the intervention
时间窗: baseline and immediately after the intervention
Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms.
Depression symptoms at 1 year
时间窗: 1 year after the intervention
Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms.
Change from baseline parent-reported anxiety symptoms to immediately after the intervention
时间窗: baseline and immediately after the intervention
Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.
Change from baseline children's reported anxiety symptoms to immediately after the intervention
时间窗: baseline and immediately after the intervention
Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.
Parent-reported anxiety symptoms at 3 months
时间窗: 3 months after the intervention
Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.
Children's reported anxiety symptoms at 3 months
时间窗: 3 months after the intervention
Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.
Parent-reported anxiety symptoms at 6 months
时间窗: 6 months after the intervention
Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.
Children's reported anxiety symptoms at 1 year
时间窗: 1 year after the intervention
Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.
Change from baseline parent-reported anxiety-related interference to immediately after the intervention
时间窗: baseline and immediately after the intervention
Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference.
Children's reported anxiety-related interference at 3 months
时间窗: 3 months after the intervention
Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference.
Children's reported anxiety symptoms at 6 months
时间窗: 6 months after the intervention
Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.
Parent-reported anxiety symptoms at 1 year
时间窗: 1 year after the intervention
Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.
Change from baseline children's reported anxiety-related interference to immediately after the intervention
时间窗: baseline and immediately after the intervention
Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference.
Parent-reported anxiety-related interference at 3 months
时间窗: 3 months after the intervention
Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference.
Parent-reported anxiety-related interference at 1 year
时间窗: 1 year after the intervention
Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference.
Children's reported anxiety-related interference at 1 year
时间窗: 1 year after the intervention
Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference.
Parent-reported anxiety-related interference at 6 months
时间窗: 6 months after the intervention
Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference.
Children's reported anxiety-related interference at 6 months
时间窗: 6 months after the intervention
Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference.
Diagnosis based on DSM-5 criteria at 3 months
时间窗: 3 months after the intervention
Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification.
Change from baseline diagnosis based on DSM-5 criteria to immediately after the intervention
时间窗: baseline and immediately after the intervention
Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification.
Diagnosis based on DSM-5 criteria at 6 months
时间窗: 6 months after the intervention
Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification.
Depression symptoms at 3 months
时间窗: 3 months after the intervention
Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms.
Depression symptoms at 6 months
时间窗: 6 months after the intervention
Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms.
次要结局
- Perfectionism(pre-intervention)
- Changes from baseline health-related quality of life to immediately after the intervention(baseline and immediately after the intervention)
- Health-related quality of life at 3 months(3 months after the intervention)
- Health-related quality of life at 1 year(1 year after the intervention)
- Health-related quality of life at 6 months(6 months after the intervention)
- Children's reported global mental health symptoms at 3 months(3 months after the intervention)
- Parent's reported global mental health symptoms at 1 year(1 year after the intervention)
- Change from baseline self-esteem to immediately after the intervention(baseline and immediately after the intervention)
- Self-esteem at 3 months(3 months after the intervention)
- Self-esteem at 6 months(6 months after the intervention)
- Self-esteem at 1 year(1 year after the intervention)
- Change from baseline children's reported global mental health symptoms to immediately after the intervention(baseline and immediately after the intervention)
- Change from baseline parent's reported global mental health symptoms to immediately after the intervention(baseline and immediately after the intervention)
- Parent's reported global mental health symptoms at 3 months(3 months after the intervention)
- Children's reported global mental health symptoms at 6 months(6 months after the intervention)
- Parent's reported global mental health symptoms at 6 months(6 months after the intervention)
- Children's reported global mental health symptoms at 1 year(1 year after the intervention)
研究者
Mireia Orgilés Amorós
Director
Universidad Miguel Hernandez de Elche