The Impact of a Virtual Magic Trick Training Program

Study Overview
=================
Brief Summary
-----------------
The proposed project will attempt to confirm the benefits of a structured magic trick training program (MTTP) experience in adolescents with unilateral cerebral palsy. Benefits of participating in a 6-week virtual MTTP will be evaluated using validated assessments to measure the extent to which adolescents use two hands in activities and improve in social-emotional competencies.

Detailed Description
-----------------
The proposed study will employ a RCT to test the two hypotheses. The design of the MTTP is based on the SELframework. 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 willbe evaluated at baseline, immediately post-program, and at 6-week follow-up (within-subject factor conditions). Sixty adolescents with UCP will be recruited for this study. Aim 1. Evaluate the therapeutic benefits of a 6-week virtual MTTP on the extent of two-handed use tocomplete daily activities, social-emotional functioning, and emotional stress among adolescents with UCP. Hypothesis #1: Adolescents with UCP who participate in a virtual MTTP will demonstrate increased use of two handsto perform daily activities, better social-emotional functioning, and a reduction in emotional stress compared to waitlistcontrols at the conclusion of a 6-week MTTP. Hypothesis #2: The positive impact of the virtual MTTP on the participants' improved number of activities performedusing two hands, social-emotional functioning, and reduction in emotional stress will be maintained at 6-week follow-up.

Official Title
-----------------
The Impact of a Virtual Magic Trick Training Program on Social Emotional Functioning in Adolescents With Hemiparesis

Conditions
-----------------
Cerebral Palsy, Hemiplegic Cerebral Palsy

Intervention / Treatment
-----------------
* Behavioral: magic trick training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis (with proof of evidence) of UCP; Aged between 12 and 18 years (younger children may lack the inductive reasoning skills to learn magic tricks); Functional ability of the affected hand between levels I and III of the Manual Activity Classification System; 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 an intensive upper limb intervention and/or new spasticity management (e.g., starting/increasing muscle relaxants, Botox injections) during the study period; or Current or planned participation in psychological therapy or a clinical trial during the study period that could affect the outcomes of the study.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: magic trick training<br>Participation in a 6 weekly virtual magic trick training camp with three lessons per week. | Behavioral: magic trick training<br>* 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.<br>|
| No Intervention: waitlist control<br>Participation in usual daily activities. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's HandExperience Questionnaire (CHEQ) | The CHEQ 2.0 evaluates the extent of participants in using their affected hand. Participants are asked to indicate how they normally perform 27 daily activities where two hands are usually required, i.e. did they typically use one hand, use two hands, or with help. Participants respond verbally to each of the 27 activity statements. The number of activities in which the participant used two hands is the outcome. | baseline | 
| Children's HandExperience Questionnaire (CHEQ) | The CHEQ 2.0 evaluates the extent of participants in using their affected hand. Participants are asked to indicate how they normally perform 27 daily activities where two hands are usually required, i.e. did they typically use one hand, use two hands, or with help. Participants respond verbally to each of the 27 activity statements. The number of activities in which the participant used two hands is the outcome. | at 6 week | 
| Children's HandExperience Questionnaire (CHEQ) | The CHEQ 2.0 evaluates the extent of participants in using their affected hand. Participants are asked to indicate how they normally perform 27 daily activities where two hands are usually required, i.e. did they typically use one hand, use two hands, or with help. Participants respond verbally to each of the 27 activity statements. The number of activities in which the participant used two hands is the outcome. | at 12 week | 
| Social Skills Improvement System (SSIS) | The Social Skills scale of the SSIS consists of seven subscales: Communication, Cooperation, Assertion, Responsibility, Empathy, Engagement, and Self-control. The social skills scale has 46 items rated on a 4-point Likert-type scale (0 = not true, 3 = very true) with higher scores representing better social skills. | baseline | 
| Social Skills Improvement System (SSIS) | The Social Skills scale of the SSIS consists of seven subscales: Communication, Cooperation, Assertion, Responsibility, Empathy, Engagement, and Self-control. The social skills scale has 46 items rated on a 4-point Likert-type scale (0 = not true, 3 = very true) with higher scores representing better social skills. | at 6 week | 
| Social Skills Improvement System (SSIS) | The Social Skills scale of the SSIS consists of seven subscales: Communication, Cooperation, Assertion, Responsibility, Empathy, Engagement, and Self-control. The social skills scale has 46 items rated on a 4-point Likert-type scale (0 = not true, 3 = very true) with higher scores representing better social skills. | at 12 week | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Dimensional Mastery Questionnaire (DMQ) | DMS consists of 41 items rated on a 5-point Likert-type scale (not like me/my child=1 to exactly like me/my child=5) with higher scores representing strong mastery motivation. | baseline | 
| Dimensional Mastery Questionnaire (DMQ) | DMS consists of 41 items rated on a 5-point Likert-type scale (not like me/my child=1 to exactly like me/my child=5) with higher scores representing strong mastery motivation. | at 6 week | 
| Dimensional Mastery Questionnaire (DMQ) | DMS consists of 41 items rated on a 5-point Likert-type scale (not like me/my child=1 to exactly like me/my child=5) with higher scores representing strong mastery motivation. | at 12 week | 
| 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 | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional stress | the amount of cortisol in participants' hair. | baseline | 
| Emotional stress | the amount of cortisol in participants' hair. | at 6 week | 
| Emotional stress | the amount of cortisol in participants' hair. | at 12 week |