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临床试验/NCT05664841
NCT05664841招募中2 期

The Impact of a Virtual Magic Trick Training Program on Social Emotional Functioning in Adolescents With Autism

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月27日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Stanford Social Dimensions Scale

研究概览

简要总结

The proposed project will attempt to confirm the benefits of a structured magic trick training program (MTTP) experience in adolescents with autism. Benefits of participating in a 6-week virtual MTTP will be evaluated using validated assessments to measure social-emotional competencies.

详细描述

The proposed study will employ a RCT to test the two hypotheses. The design of the MTTP is based on the SEL framework. The study will incorporate a 2 x 3 two-way factorial design with repeated measures at three time points. The two between-subject factor conditions will be participation in a MTTP versus a waitlist control condition that will be evaluated at baseline, immediately post-program, and at 6-week follow-up (within-subject factor conditions). Sixty adolescents with autism will be recruited for this study.

Aim 1. Evaluate the therapeutic benefits of a 6-week virtual MTTP on social-emotional functioning, and emotional stress among adolescents with autism.

Hypothesis #1: Adolescents with autism who participate in a virtual MTTP will demonstrate better social-emotional functioning, and a reduction in emotional stress compared to waitlist controls at the conclusion of a 6-week MTTP.

Hypothesis #2: The positive impact of the virtual MTTP on the participants' improved social-emotional functioning, and reduction in emotional stress will be maintained at 6-week follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
11 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis (with proof of evidence) of autism;
  • Aged between 11 and 18 years (younger children may lack the inductive reasoning skills to learn magic tricks);
  • Have functional hand dexterity to do magic tricks
  • Intact cognition as indicated by a score above the corresponding cut-off point of the child's age on the Mini-Mental Examination for Children; and
  • Access to internet and a computer or smartphone that can perform videoconferencing.

排除标准

  • Severe hearing or visual impairments that prevent online learning;
  • Previous participation in organized magic learning program or camp;
  • Current or planned participation in psychological therapy or a clinical trial during the study period that could affect the outcomes of the study.

研究组 & 干预措施

magic trick training

Experimental

Participation in a 6 weekly virtual magic trick training camp with three lessons per week.

干预措施: magic trick training (Behavioral)

waitlist control

No Intervention

Participation in usual daily activities.

结局指标

主要结局

Stanford Social Dimensions Scale

时间窗: at 12 week

The SSDS is more comprehensive, sensitive and specific compared to other instruments in terms of capturing key social processes that are necessary for understanding of social deficits in conditions. The 71 items are rated on a 5-point Likert scale with 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always.

Test of Adolescents Social Skills Knowledge (TASSK)

时间窗: at 12 week

The TASSK is a self-report 30-item questionnaire that measures knowledge of specific social skills. Scores range between 0 to 26 with higher score reflecting greater knowledge of adolescent social skills.

Rosenberg Self Esteem Scale (RSES)

时间窗: at 12 week

RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem.

Self-efficacy Questionnaire for Children

时间窗: at 12 week

It consists of 16 items rated on a 5-point Likert-type scale (not at all=1 to very well=5) with higher scores indicating higher self-efficacy.

Strengths and Difficulties Questionnaire (SDQ)

时间窗: at 12 week

SDQ (peer problem scale and prosocial scale) consists of 10 items rated on a 3-point Likert-type scale (not true=1 to certainly true=3), with higher scores indicating higher psychological problems. Some items require reverse scoring.

UCLA Loneliness Scale Version 3

时间窗: at 12 week

The UCLA Loneliness Scale (Version 3) is a 20-item measure that assesses how often a person feels disconnected from others. Using a 4-point rating scale (1= never; 4 = always), participants answer 20 questions, such as "How often do you feel left out?" and "How often do you feel part of a group of friends?" Researchers later reverse-code the positively worded items so that high values mean more loneliness, and then calculate a score for each respondent by averaging their ratings.

Best Friend Index

时间窗: at 12 week

The Best Friend Index is a scale for the measurement of the features of positive and negative friendship consisting of 18 items. Each item is answered on a 5-point scale (from 1= Never to 5=Very often).

Quality of Socialization Questionnaire

时间窗: at 12 week

It is a 12-item self-report and parent-report measure to assess the frequency of adolescents get-together, number of friends involved and the level of conflict during get-togethers over the previous month.

Autism Social Skills Profile

时间窗: at 12 week

It is a checklist that provides a comprehensive measure of social functioning of children and adolescents who are on the Autism Spectrum. The 49 items are rated on a 4-point Likert scale with 1=never, 2=sometimes, 3=often, and 4=very often. The test yields three subscale scores: Social/Emotional Reciprocity (SER), Social Participation/Avoidance (SPA), and Detrimental Social Behaviors (DSB), as well as a total score.

Test of Adolescents Social Skills Knowledge (TASSK)

时间窗: baseline

The TASSK is a self-report 30-item questionnaire that measures knowledge of specific social skills. Scores range between 0 to 26 with higher score reflecting greater knowledge of adolescent social skills.

Test of Adolescents Social Skills Knowledge (TASSK)

时间窗: at 6 week

The TASSK is a self-report 30-item questionnaire that measures knowledge of specific social skills. Scores range between 0 to 26 with higher score reflecting greater knowledge of adolescent social skills.

Strengths and Difficulties Questionnaire (SDQ)

时间窗: baseline

SDQ (peer problem scale and prosocial scale) consists of 10 items rated on a 3-point Likert-type scale (not true=1 to certainly true=3), with higher scores indicating higher psychological problems. Some items require reverse scoring.

Strengths and Difficulties Questionnaire (SDQ)

时间窗: at 6 week

SDQ (peer problem scale and prosocial scale) consists of 10 items rated on a 3-point Likert-type scale (not true=1 to certainly true=3), with higher scores indicating higher psychological problems. Some items require reverse scoring.

Rosenberg Self Esteem Scale (RSES)

时间窗: baseline

RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem.

Rosenberg Self Esteem Scale (RSES)

时间窗: at 6 week

RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem.

UCLA Loneliness Scale Version 3

时间窗: baseline

The UCLA Loneliness Scale (Version 3) is a 20-item measure that assesses how often a person feels disconnected from others. Using a 4-point rating scale (1= never; 4 = always), participants answer 20 questions, such as "How often do you feel left out?" and "How often do you feel part of a group of friends?" Researchers later reverse-code the positively worded items so that high values mean more loneliness, and then calculate a score for each respondent by averaging their ratings.

UCLA Loneliness Scale Version 3

时间窗: at 6 week

The UCLA Loneliness Scale (Version 3) is a 20-item measure that assesses how often a person feels disconnected from others. Using a 4-point rating scale (1= never; 4 = always), participants answer 20 questions, such as "How often do you feel left out?" and "How often do you feel part of a group of friends?" Researchers later reverse-code the positively worded items so that high values mean more loneliness, and then calculate a score for each respondent by averaging their ratings.

Self-efficacy Questionnaire for Children

时间窗: baseline

It consists of 16 items rated on a 5-point Likert-type scale (not at all=1 to very well=5) with higher scores indicating higher self-efficacy.

Self-efficacy Questionnaire for Children

时间窗: at 6 week

It consists of 16 items rated on a 5-point Likert-type scale (not at all=1 to very well=5) with higher scores indicating higher self-efficacy.

Best Friend Index

时间窗: baseline

The Best Friend Index is a scale for the measurement of the features of positive and negative friendship consisting of 18 items. Each item is answered on a 5-point scale (from 1= Never to 5=Very often).

Best Friend Index

时间窗: at 6 week

The Best Friend Index is a scale for the measurement of the features of positive and negative friendship consisting of 18 items. Each item is answered on a 5-point scale (from 1= Never to 5=Very often).

Quality of Socialization Questionnaire

时间窗: baseline

It is a 12-item self-report and parent-report measure to assess the frequency of adolescents get-together, number of friends involved and the level of conflict during get-togethers over the previous month.

Quality of Socialization Questionnaire

时间窗: at 6 week

It is a 12-item self-report and parent-report measure to assess the frequency of adolescents get-together, number of friends involved and the level of conflict during get-togethers over the previous month.

Autism Social Skills Profile

时间窗: baseline

It is a checklist that provides a comprehensive measure of social functioning of children and adolescents who are on the Autism Spectrum. The 49 items are rated on a 4-point Likert scale with 1=never, 2=sometimes, 3=often, and 4=very often. The test yields three subscale scores: Social/Emotional Reciprocity (SER), Social Participation/Avoidance (SPA), and Detrimental Social Behaviors (DSB), as well as a total score.

Autism Social Skills Profile

时间窗: at 6 week

It is a checklist that provides a comprehensive measure of social functioning of children and adolescents who are on the Autism Spectrum. The 49 items are rated on a 4-point Likert scale with 1=never, 2=sometimes, 3=often, and 4=very often. The test yields three subscale scores: Social/Emotional Reciprocity (SER), Social Participation/Avoidance (SPA), and Detrimental Social Behaviors (DSB), as well as a total score.

Stanford Social Dimensions Scale

时间窗: baseline

The SSDS is more comprehensive, sensitive and specific compared to other instruments in terms of capturing key social processes that are necessary for understanding of social deficits in conditions. The 71 items are rated on a 5-point Likert scale with 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always.

Stanford Social Dimensions Scale

时间窗: at 6 week

IThe SSDS is more comprehensive, sensitive and specific compared to other instruments in terms of capturing key social processes that are necessary for understanding of social deficits in conditions. The 71 items are rated on a 5-point Likert scale with 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always.

次要结局

  • Emotional stress(at 12 week)
  • Emotional stress(baseline)
  • Emotional stress(at 6 week)

研究者

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

Hon K. Yuen, PhD

Professor

University of Alabama at Birmingham

研究点 (1)

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