跳至主要内容
临床试验/NCT05589090
NCT05589090已完成不适用

Adaptación y evaluación Del Programa transdiagnóstico Super Skills for Life Aplicado Online Para niños Con Problemas Interiorizados

Universidad Miguel Hernandez de Elche2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Depression symptoms at 1 year

研究概览

简要总结

The study aims to evaluate the effectiveness of the transdiagnostic program Super Skills for Life (SSL). This protocol targets children aged 8 to 12 with emotional problems (anxiety, 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 present research focuses on assessing the effectiveness of SSL applied online (through a virtual platform).

详细描述

After selecting the children based on the online questionnaires completed by the parents (preintervention assessment) and inclusion/exclusion criteria, they were randomly allocated to the conditions of the intervention group and the wait-list control group. Parents and children from both groups completed the same measures at baseline, post-treatment, and 12 months follow-up. Children in the experimental group received the SSL program by the virtual platform.

The objective of the study is to evaluate the benefits of the Super Skills for Life protocol applied online. For this purpose, the researchers will test to what extent the experimental group decreases its anxiety symptoms, anxiety impairment, depressive symptoms, behavioral problems, hyperactivity/inattention, and peer relationship problems, and increase its self-esteem and prosocial behaviors, compared to the control group.

In conclusion, the purpose of the study is to explore whether SSL implemented online can be a cost-effective psychological intervention to prevent emotional problems in Spanish children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
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

入选标准

  • Children aged 8-12
  • Presenting subclinical symptoms of emotional problems (anxiety, depression)
  • Speaking, reading, writing, and understanding Spanish.
  • Not receiving psychological or pharmacological treatment for emotional and/or behavioral problems

排除标准

  • Had a psychiatric diagnosis already established
  • Presenting a severe developmental disorder (intellectual disability, autism spectrum disorder, etc).

结局指标

主要结局

Depression symptoms at 1 year

时间窗: 1 year after the intervention

Measured by the Mood and Feelings Questionnaire (MFQ-C; short version), a screening tool for depression in children aged 6-17 years. Children must report their feelings and behaviors over the previous 2 weeks. The sum of all items provides a total measure of depression (score range: 0-26), and the higher this score is, the more severe the symptoms are.

Parent-reported depression at 1 year

时间窗: 1 year after the intervention

Measured by the Mood and Feelings Questionnaire (MFQ-P; short version), a screening tool for depression in children aged 6-17 years. Parents must inform about their children's feelings and behaviors over the previous 2 weeks. The sum of all items provides a total measure of depression (score range: 0-26), and the higher this score is, the more severe the symptoms are.

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; short version). 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). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicate greater severity of symptoms

Change from baseline parent-reported psychological adjustment to immediately after the intervention

时间窗: baseline and immediately after the intervention

Measured by Strengths and Difficulties Questionnaire Parental Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute.

Parent-reported anxiety at 1 year

时间窗: 1 year after the intervention

Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P; short version). 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). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicate greater severity of symptoms.

Change from baseline depression symptoms to immediately after the intervention

时间窗: 1 year after the intervention

Measured by the Mood and Feelings Questionnaire (MFQ-C; short version), a screening tool for depression in children aged 6-17 years. Children must report their feelings and behaviors over the previous 2 weeks. The sum of all items provides a total measure of depression (score range: 0-26), and the higher this score is, the more severe the symptoms are.

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; short version). 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). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicate greater severity of symptoms.

Parent-reported psychological adjustment at 1 year

时间窗: 1 year after the intervention

Measured by Strengths and Difficulties Questionnaire Parental Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute.

Change from baseline parent-reported depression to immediately after the intervention

时间窗: baseline and immediately after the intervention

Measured by the Mood and Feelings Questionnaire (MFQ-P; short version), a screening tool for depression in children aged 6-17 years. Parents must inform about their children's feelings and behaviors over the previous 2 weeks. The sum of all items provides a total measure of depression (score range: 0-26), and the higher this score is, the more severe the symptoms are.

Change from baseline children's reported psychological adjustment to immediately after the intervention

时间窗: baseline and immediately after the intervention

Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute.

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; short version). 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). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicate greater severity of symptoms

Children's reported psychological adjustment at 1 year

时间窗: 1 year after the intervention

Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute.

次要结局

  • Change from baseline self-concept to immediately after the intervention(baseline and immediately after the intervention)
  • Change from baseline social worries to immediately after the intervention(baseline and immediately after the intervention)
  • Children's social worries at 1 year(1 year after the intervention)
  • Children's self-concept at 1 year(1 year after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mireia Orgilés Amorós

Director

Universidad Miguel Hernandez de Elche

研究点 (2)

Loading locations...

相似试验

Super Skills for Life Effectiveness in the Online... | 临床试验