Emotional Regulation Clinical Trial
Official title:
Examining the Impacts of Parent-Child Interactive Activities as an Adjunct to Mightier Play
NCT number | NCT04839861 |
Other study ID # | 874MIGH21 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 7, 2021 |
Est. completion date | October 13, 2021 |
Verified date | October 2021 |
Source | Neuromotion Labs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to demonstrate the effects of online and offline play of games on the Mightier game platform, in comparison to the effects of Mightier online play alone.
Status | Completed |
Enrollment | 42 |
Est. completion date | October 13, 2021 |
Est. primary completion date | October 13, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: - Age 6-12 at the time of screening - Regular access to WiFi (for Mightier gameplay device connection) Exclusion Criteria: - Prior Mightier use - Diagnosed Intellectual Disability (by history) - Planned medication changes during the 6-week study period |
Country | Name | City | State |
---|---|---|---|
United States | Neuromotion Labs | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Neuromotion Labs |
United States,
RC Pianta - Unpublished measure, University of Virginia, 1992
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 child irritability from baseline measured on ARI-P at Week 7 | 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. | Baseline and Week 7 | |
Primary | Change in child-parent relationship from baseline measured on CPRS-SF at Week 7 | Child-Parent Relationship Scale (CPRS-SF): The CPRS-SF is a 15- item The CPRS (Pianta, 1992) is a self-report instrument completed by parents that assesses their perceptions of their relationship with their child. The 15 items are rated on 5-point Likert scales. It is applicable to children ages 3-12. The CPRS-SF is scored in two subscales: an 8-item Conflict subscale (minimum score = 8, maximum score = 40, higher score indicates greater conflict), and a 7-item Closeness subscale (minimum score = 7, maximum score = 35, with greater score indicating greater closeness). | Baseline and Week 7 | |
Primary | Parent perception of change in child emotion regulation from baseline measured on GIS at Week 7 | Global Improvement Scale (GIS): The GIS is a parent self-report question that asks parents if they have noticed any overall improvements in their child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. Minimum score = 1, Maximum score = 7, with higher numbers indicating less improvement, or worsening. The GIS has not been scientifically validated. | Week 7 |
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 |
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 | |
Enrolling by invitation |
NCT05859126 -
Maternal Choline Supplementation and Offspring Cognition in Adolescence
|
N/A |