- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05664841
The Impact of a Virtual Magic Trick Training Program
The Impact of a Virtual Magic Trick Training Program on Social Emotional Functioning in Adolescents With Autism
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Hon Yuen
- Phone Number: 205-934-6301
- Email: yuen@uab.edu
Study Contact Backup
- Name: Kimberly Kirklin
- Phone Number: 205-934-0862
- Email: kkirklin@uab.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama at Birmingham
-
Contact:
- Hon K Yuen, PhD
-
Principal Investigator:
- Hon K Yuen, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: magic trick training
Participation in a 6 weekly virtual magic trick training camp with three lessons per week.
|
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.
|
|
No Intervention: waitlist control
Participation in usual daily activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: 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.
|
baseline
|
|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: 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.
|
at 6 week
|
|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: 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.
|
at 12 week
|
|
Rosenberg Self Esteem Scale (RSES)
Time Frame: baseline
|
RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem.
|
baseline
|
|
Rosenberg Self Esteem Scale (RSES)
Time Frame: at 6 week
|
RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem.
|
at 6 week
|
|
Rosenberg Self Esteem Scale (RSES)
Time Frame: at 12 week
|
RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem.
|
at 12 week
|
|
Self-efficacy Questionnaire for Children
Time Frame: 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.
|
baseline
|
|
Self-efficacy Questionnaire for Children
Time Frame: 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.
|
at 6 week
|
|
Self-efficacy Questionnaire for Children
Time Frame: 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.
|
at 12 week
|
|
Test of Adolescents Social Skills Knowledge (TASSK)
Time Frame: 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.
|
baseline
|
|
Test of Adolescents Social Skills Knowledge (TASSK)
Time Frame: 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.
|
at 6 week
|
|
Test of Adolescents Social Skills Knowledge (TASSK)
Time Frame: 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.
|
at 12 week
|
|
UCLA Loneliness Scale Version 3
Time Frame: 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.
|
baseline
|
|
UCLA Loneliness Scale Version 3
Time Frame: 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.
|
at 6 week
|
|
UCLA Loneliness Scale Version 3
Time Frame: 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.
|
at 12 week
|
|
Best Friend Index
Time Frame: 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).
|
baseline
|
|
Best Friend Index
Time Frame: 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).
|
at 6 week
|
|
Best Friend Index
Time Frame: 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).
|
at 12 week
|
|
Quality of Socialization Questionnaire
Time Frame: 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.
|
baseline
|
|
Quality of Socialization Questionnaire
Time Frame: 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.
|
at 6 week
|
|
Quality of Socialization Questionnaire
Time Frame: 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.
|
at 12 week
|
|
Autism Social Skills Profile
Time Frame: 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.
|
baseline
|
|
Autism Social Skills Profile
Time Frame: 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.
|
at 6 week
|
|
Autism Social Skills Profile
Time Frame: 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.
|
at 12 week
|
|
Stanford Social Dimensions Scale
Time Frame: 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.
|
baseline
|
|
Stanford Social Dimensions Scale
Time Frame: 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.
|
at 6 week
|
|
Stanford Social Dimensions Scale
Time Frame: 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.
|
at 12 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional stress
Time Frame: baseline
|
the amount of cortisol in participants' hair.
|
baseline
|
|
Emotional stress
Time Frame: at 6 week
|
the amount of cortisol in participants' hair.
|
at 6 week
|
|
Emotional stress
Time Frame: at 12 week
|
the amount of cortisol in participants' hair.
|
at 12 week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hon Yuen, PhD, University of Alabama at Birmingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1909503-38
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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