Emotional Regulation Clinical Trial
Official title:
Examining the Impacts on In-School Behaviors of In-Home Engagement With a Biofeedback-based Videogame Application
Verified date | June 2022 |
Source | Neuromotion Labs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The proposed study aims to investigate the effects of children's in-home engagement with a biofeedback video game-based intervention on children's in-school behaviors. For the proposed study, families with no prior Mightier exposure will engage in online gameplay for eight weeks. Mightier will recruit families through social media and clinical settings, then Mightier will randomly assign participants to one of two groups: a group in which the child participant is encouraged to play Mightier games with biofeedback elements 45 or more minutes a week, broken into 3 or more sessions a week soon after baseline data have been collected, and a group in which the child participant receives Mightier and is invited to play Mightier games with biofeedback elements after all study baseline and follow-up data have been collected. The investigators will aim to enroll 20 parent-child dyads in each group. Specific Aims and Hypotheses: 1. Demonstrate that child engagement in Mightier biofeedback video games is correlated to child improvement in school behaviors. The investigators hypothesize that teachers of child participants will report reductions in child school behavior challenges after 8 weeks of child Mightier gameplay. 2. Demonstrate that child engagement in Mightier biofeedback video games is correlated to child improvement in at-home behaviors and general improvement in emotion regulation. The investigators hypothesize that parents of child participants will report a reduction in child behavior challenges and improvements in child emotion regulation after 8 weeks of child Mightier gameplay.
Status | Active, not recruiting |
Enrollment | 43 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 11 Years |
Eligibility | Inclusion Criteria: - Age 6-11 at the time of screening - Attending school outside of the home and not planning to change schools or classrooms during the 8-week study period Exclusion Criteria: - Prior Mightier use - Out-of-home School Teacher unable to complete baseline and follow-up questionnaires - Planned medication changes during the 8-week study period - Parents encouraged to self-exclude if their children have severe skin sensitivities - Parents encouraged to self-exclude if their children are pre-readers |
Country | Name | City | State |
---|---|---|---|
United States | Neuromotion Labs | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Neuromotion Labs |
United States,
Achenbach, T. M., & Rescorla, L. A. (2001). Manual for the ASEBA School-Age Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
Ducharme P, Kahn J, Vaudreuil C, Gusman M, Waber D, Ross A, Rotenberg A, Rober A, Kimball K, Peechatka AL, Gonzalez-Heydrich J. A "Proof of Concept" Randomized Controlled Trial of a Video Game Requiring Emotional Regulation to Augment Anger Control Training. Front Psychiatry. 2021 Sep 1;12:591906. doi: 10.3389/fpsyt.2021.591906. eCollection 2021. — View Citation
Guy, WBRR (1976). CGI. Clinical global impressions. ECDEU assessment manual for psychopharmacology.
Stringaris A, Goodman R, Ferdinando S, Razdan V, Muhrer E, Leibenluft E, Brotman MA. The Affective Reactivity Index: a concise irritability scale for clinical and research settings. J Child Psychol Psychiatry. 2012 Nov;53(11):1109-17. doi: 10.1111/j.1469-7610.2012.02561.x. Epub 2012 May 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in in-school problem behaviors from baseline to follow-up | Child Behavior Checklist- Teacher Report Form (CBCL-TRF): The CBCL-TRF (Achenbach & Rescorla, 2001) assesses child adaptive behaviors and problem behaviors. There are 112 items that assess problem behaviors and 16 items that assess academic performance and adaptive behavior. School teachers of child participants will complete the CBCL-TRF at baseline and Week 8. | Baseline and Week 8 | |
Primary | Change in in-home problem behaviors from baseline to follow-up | Child Behavior Checklist (CBCL/6-18): The CBCL/6-18 (Achenbach & Rescorla, 2001) assesses child adaptive behaviors and problem behaviors. There are 112 items that assess problem behaviors and 20 items that assess adaptive behavior. Response format for problem behaviors is from 0 ("not true") to 2 ("very true"). Parent participants will complete the CBCL/6-18 at baseline and follow-up. | Baseline and Week 8 | |
Primary | Change in irritable mood from baseline to follow-up | Affective Reactivity Index- Parent Report (ARI-P): The ARI is a 7-item scale that consists of 6 symptom items and 1 impairment item. The scale was designed to determine irritable mood rather than behavioral consequences such as hostility and acts of aggression (Stringaris et al., 2012). The individual items are scored 0,1, 2, and only the first six items are summed to form the total score, with a minimum score of 0 and a maximum score of 18, and higher scores indicating greater severity of irritability symptoms. The seventh item is an impairment item and it is analysed separately, with a minimum score of 0 and a maximum score of 3, and higher scores indicating greater irritability symptom severity. Parent participants will complete the ARI-P at baseline and Week 8. | Baseline and Week 8 | |
Primary | Overall emotional regulation improvement as reported by teacher | Clinical Global Impressions Scale Improvement Question (CGI-I): The CGI is a self-report question that asks the respondent if they have noticed any overall improvements in the child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. The Teacher CGI-I has not been scientifically validated for use in research studies. Teachers of child participants will complete the CGI-I at follow-up. | Week 8 | |
Primary | Overall emotional regulation improvement as reported by parent | Clinical Global Impressions Scale Improvement Question (CGI-I): The CGI is a self-report question that asks the respondent if they have noticed any overall improvements in the child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. The Parent CGI-I has not been scientifically validated for use in research studies. Parents of child participants will complete the CGI-I at follow-up. | Week 8 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
Recruiting |
NCT05545241 -
Awareness of Emotional Feelings and Management of Risky Situations
|
N/A | |
Completed |
NCT05543811 -
The Influence of Food for Special Dietary Use - Spread Enriched With 5-hydroxytryptophan, Theanine and Gamma-aminobutyric Acid on Psychophysiological Functions of Subjects Without Meaningful Organic and Cognitive Pathology
|
N/A | |
Completed |
NCT04558411 -
Brief, Scaleable Intervention for Coronavirus (COVID-19) Mental Health Sequelae in College Students
|
N/A | |
Completed |
NCT03124446 -
Mindfulness-Based College: Stage 1
|
N/A | |
Recruiting |
NCT04733300 -
Online Mindfulness-Based College for Young Adults
|
N/A | |
Completed |
NCT06085391 -
Testing the Efficacy of the REThink Emotions Platform in a Full-scale SMART Study
|
N/A | |
Completed |
NCT05080647 -
Examining the Impacts of Parent Mightier Play
|
N/A | |
Completed |
NCT05027113 -
App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress
|
N/A | |
Completed |
NCT04536935 -
Mobile Mental Health Apps for Suicide Prevention
|
N/A | |
Completed |
NCT05607784 -
Education Program to Reduce Risky Behavior in Adolescents Ph I
|
||
Completed |
NCT04839861 -
Examining the Impacts of Parent-Child Interactive Activities
|
N/A | |
Completed |
NCT04942678 -
The Impact of Therapy Dogs on Anxiety and Emotional Management in the Pediatric Emergency Department
|
||
Completed |
NCT02661880 -
The Role of Music in Palliative Care: A Proposal for a Rural Based Initiative in Music Based Interventions
|
N/A | |
Recruiting |
NCT06267521 -
The STRENGTHEN Study
|
N/A | |
Recruiting |
NCT06054412 -
An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers
|
N/A | |
Recruiting |
NCT05718427 -
Effect of ASI on Sensory, Motor, Cognitive, Behavioral Skills and Social Participation in Children With ADHD
|
N/A | |
Not yet recruiting |
NCT05531318 -
Emotional Regulation in People With Co-occurring Posttraumatic Stress Disorder and Substance Use Disorder
|
||
Recruiting |
NCT05472545 -
Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth
|
N/A | |
Recruiting |
NCT05022550 -
Virtual-reality and Emotion Regulation in Violence-Exposed Youth
|
N/A |