Rehabilitation of Executive Functions and Social Skills in Adolescents With Neurological Condition by Using the Italian Version of the Teen Online Problem-Solving (TOPS) Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - parent form - baseline
研究概览
简要总结
The study aims at evaluating the feasibility and the efficacy of the Teen On-line Problem Solving program (TOPS) in improving executive functioning and behavior problems in adolescents with neurological condition aged 11-19 years.
In order to control for placebo effects, participants are randomized into two intervention conditions. Group 1 performs the regular version of the TOPS, while Group 2 performs a modified version containing no activities on executive functions, behavioral strategies and social skills.
详细描述
Adolescents with neurological condition often present with executive dysfunction and behavioral and social problems. Ad hoc rehabilitation may significantly ameliorate such difficulties. With this aim, the Teen On-line Problem-Solving program (TOPS) could represent a suitable opportunity of intervention, as it aims at helping patients to improve executive and behavioral functioning. The program consists of a web-based platform composed of 10 core sessions and eventual supplementary sessions, providing information and activities on executive functioning, behavioral strategies, social skills. injury-related issues and health and wellness. The program is delivered remotely, with patients performing the intervention at home, together with their families. Biweekly Google Meet sessions with a cognitive-behavioral psychotherapist are scheduled along the entire duration of the intervention to monitor the activities related to the program and the real-life problem-solving process that patients are required to perform during the intervention.
Assessment of executive functions and behavioral problems is conducted before and after the training (immediate post training assessment and follow-up assessment 6 months after the end of the training), in order to investigate the presence of significant changes after the intervention. Both questionnaires and performance-based measures are used.
Participants are randomized into two groups: Group 1 performs the regular version of the TOPS, while Group 2 performs a modified version containing no activities on executive functions, behavioral strategies and social skills.
Based on the average effect of TOPS program reported by a meta-analysis available in the literature (Corti et al., 2019; Hedge's g = 0.39) we estimated a small-to-moderate effect size of f =0.2 (f was calculated based on Hedge's g value). Power analysis was conducted by using GPower3 software. Assuming a correlation of 0.50 between repeated measures and setting the alfa level at P < 0.05, a sample size of 21 subjects per group is required to obtain 80% of power with our 2 groups x 3 time points design.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Outcomes assessors and participants are blinded with respect to group assignment, as both Group 1 and Group 2 use the TOPS program platform, even though with different contents.
入排标准
- 年龄范围
- 11 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of neurological condition (non-progressive aquired brain injury, brain tumor, epilepsy etc.)
排除标准
- •history of abuse
- •familiarity for psychiatric hospitalization
研究组 & 干预措施
regular TOPS group
Patients are required to perform the regular TOPS program, composed of 10 core sessions and other eventual supplementary sessions. In addition, biweekly Google Meet sessions with a cognitive-behavioral psychotherapist are scheduled, with the aim to monitor patients' activities on problem-solving related to the TOPS program contents and the problem solving process in real life. The program has a specific focus on problem-solving, executive functions, behavioral strategies and social skills.
干预措施: Teen On-line Problem Solving (Device)
modified TOPS group
Patients are required to perform the modified TOPS program, composed of 10 sessions focused only on health and wellness contents. Thus, this program does not include contents on problem-solving, executive functions, behavioral strategies and social skills, representing a low cognitively simulating activity. Biweekly Google Meet sessions with a cognitive-behavioral psychotherapist are scheduled, with the aim of monitoring training adherence and discuss the program's contents.
干预措施: Teen On-line Problem Solving (Device)
结局指标
主要结局
Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - parent form - baseline
时间窗: baseline (immediately pre-training)
The BRIEF questionnaire is aimed at assessing executive functioning at home and school and contains 63 items in different clinical scales and validity scales. The questionnaire is administered to parents, which have to rate the frequency of dysexecutive problems of their children on a 3-point Likert Scale. Raw scores of the global scale range from 63 to 189. T scores (M = 50, SD = 10) are used to interpret the level of executive functioning. Higher scores mean a worse outcome.
Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - parent form - change at 6 months (immediately post-training)
时间窗: post-training (approximatively at month 6)
The BRIEF questionnaire is aimed at assessing executive functioning at home and school and contains 63 items in different clinical scales and validity scales. The questionnaire is administered to parents, which have to rate the frequency of dysexecutive problems of their children on a 3-point Likert Scale. Raw scores of the global scale range from 63 to 189. T scores (Mean-M = 50, Standard Deviation-SD = 10) are used to interpret the level of executive functioning. Higher scores mean a worse outcome.
Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - parent form - change at 12 months (follow-up at 6 months after the end of the training)
时间窗: follow-up (approximatively at month 12)
The BRIEF questionnaire is aimed at assessing executive functioning at home and school and contains 63 items in different clinical scales and validity scales. The questionnaire is administered to parents, which have to rate the frequency of dysexecutive problems of their children on a 3-point Likert Scale. Raw scores of the global scale range from 63 to 189. T scores (M = 50, SD = 10) are used to interpret the level of executive functioning. Higher scores mean a worse outcome.
次要结局
- Back Anxiety Inventory (BAI) - change at 12 months(post-training (approximatively at month 12))
- Symptom Checklist 90 (SCL-90) - change at 6 months(post-training (approximatively at month 6))
- Symptom Checklist 90 (SCL-90) - baseline(baseline (immediately pre-training))
- Symptom Checklist 90 (SCL-90) - change at 12 months(post-training (approximatively at month 12))
- A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - baseline(baseline (immediately pre-training))
- Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - change at 6 months(post-training (approximatively at month 6))
- Parenting Stress Index (PSI) - Short Form - change at 6 months(post-training (approximatively at month 6))
- Parenting Stress Index (PSI) - Short Form - change at 12 months(post-training (approximatively at month 12))
- Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - baseline(baseline (immediately pre-training))
- Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - change at 12 months(post-training (approximatively at month 12))
- A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - change at 6 months(post-training (approximatively at month 6))
- A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - change at 12 months(post-training (approximatively at month 12))
- Child Behavior Checklist 6-18 (CBCL 6-18) - baseline(baseline (immediately pre-training))
- Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - baseline(baseline (immediately pre-training))
- Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - change at 6 months(post-training (approximatively at month 6))
- Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - change at 12 months(post-training (approximatively at month 12))
- Child Behavior Checklist 6-18 (CBCL 6-18) - change at 6 months(post-training (approximatively at month 6))
- Child Behavior Checklist 6-18 (CBCL 6-18) - change at 12 months(post-training (approximatively at month 12))
- Youth Self-Report 11-18 (YSR 11-18) - change at 6 months(post-training (approximatively at month 6))
- Youth Self-Report 11-18 (YSR 11-18) - baseline(baseline (immediately pre-training))
- Back Anxiety Inventory (BAI) - baseline(baseline (immediately pre-training))
- Back Anxiety Inventory (BAI) - change at 6 months(post-training (approximatively at month 6))
- Youth Self-Report 11-18 (YSR 11-18) - change at 12 months(post-training (approximatively at month 12))
- Parenting Stress Index (PSI) - Short Form - baseline(baseline (immediately pre-training))