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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05664841
Other study ID # 1909503-38
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 27, 2023
Est. completion date February 1, 2025

Study information

Verified date April 2024
Source University of Alabama at Birmingham
Contact Hon Yuen
Phone 205-934-6301
Email yuen@uab.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Behavioral:
magic trick training
A typical session will begin with the magician demonstrating a magic trick then revealing the secret move of the trick.The participants will learn and practice each trick. With assistance from the magician, participants will develop an oralstory presentation for the trick. After participants master one trick, the magician will demonstrate and teach the next.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (1)

Spencer K, Yuen HK, Jenkins GR, Kirklin K, Vogtle LK, Davis D. The 'magic' of magic camp from the perspective of children with hemiparesis. J Exerc Rehabil. 2021 Feb 23;17(1):15-20. doi: 10.12965/jer.2040802.401. eCollection 2021 Feb. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Test of Adolescents Social Skills Knowledge (TASSK) 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. baseline
Primary Test of Adolescents Social Skills Knowledge (TASSK) 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. at 6 week
Primary Test of Adolescents Social Skills Knowledge (TASSK) 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. at 12 week
Primary Strengths and Difficulties Questionnaire (SDQ) 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. baseline
Primary Strengths and Difficulties Questionnaire (SDQ) 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. at 6 week
Primary Strengths and Difficulties Questionnaire (SDQ) 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. at 12 week
Primary Rosenberg Self Esteem Scale (RSES) RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem. baseline
Primary Rosenberg Self Esteem Scale (RSES) RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem. at 6 week
Primary Rosenberg Self Esteem Scale (RSES) RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem. at 12 week
Primary UCLA Loneliness Scale Version 3 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. baseline
Primary UCLA Loneliness Scale Version 3 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. at 6 week
Primary UCLA Loneliness Scale Version 3 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. at 12 week
Primary Self-efficacy Questionnaire for Children 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. baseline
Primary Self-efficacy Questionnaire for Children 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. at 6 week
Primary Self-efficacy Questionnaire for Children 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. at 12 week
Primary Best Friend Index 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). baseline
Primary Best Friend Index 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). at 6 week
Primary Best Friend Index 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). at 12 week
Primary Quality of Socialization Questionnaire 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. baseline
Primary Quality of Socialization Questionnaire 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. at 6 week
Primary Quality of Socialization Questionnaire 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. at 12 week
Primary Autism Social Skills Profile 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. baseline
Primary Autism Social Skills Profile 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. at 6 week
Primary Autism Social Skills Profile 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. at 12 week
Primary Stanford Social Dimensions Scale 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. baseline
Primary Stanford Social Dimensions Scale 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. at 6 week
Primary Stanford Social Dimensions Scale 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. at 12 week
Secondary Emotional stress the amount of cortisol in participants' hair. baseline
Secondary Emotional stress the amount of cortisol in participants' hair. at 6 week
Secondary Emotional stress the amount of cortisol in participants' hair. at 12 week
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