Examining the Impacts of Parent-Child Interactive Activities
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2021
CompletedFirst Posted
Study publicly available on registry
April 9, 2021
CompletedStudy Start
First participant enrolled
May 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2021
CompletedOctober 20, 2021
October 1, 2021
5 months
April 7, 2021
October 19, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (2)
Mightier Online Games
ACTIVE COMPARATOR6 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier online games at least 3 times a week for the 6 week duration.
Mightier Online Plus Offline Family Games
EXPERIMENTAL6 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier online games at least 3 times a week for the 6 week duration. Parents will be encouraged to play Mightier offline Family Games at least once a week for the 6 week duration.
Interventions
Mightier Family Games includes five offline card games that can be played by two or more people. During card game play, one player wears the Mightier heart rate monitor, and can see a representation of their heart rate on a separate screen within the Mightier app. Each game includes elements that are tied to heart rate.
Mightier is a video-game-based biofeedback intervention that capitalizes on children's love of video games to increase emotional awareness and facilitate emotion regulation practice through heart rate (HR) control. Each family receives a Mightier Kit (Mighty Band heart rate monitor, dedicated Mightier tablet unless the family prefers to use their own device) and the Mightier App. Children wear a "Mighty Band" heart rate monitor on their arm while they play any one of 26+ games. As their heart rate rises the games become more difficult. For example, during a cooking game, smoke may appear on the screen and obscure the player's view. Children can either opt into an explicit cool down activity (deep breathing, progressive muscle relaxation, crossing the midline, or visualization) or cool down on their own.
Eligibility Criteria
You may qualify if:
- Age 6-12 at the time of screening
- Regular access to WiFi (for Mightier gameplay device connection)
You may not qualify if:
- Prior Mightier use
- Diagnosed Intellectual Disability (by history)
- Planned medication changes during the 6-week study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuromotion Labslead
Study Sites (1)
Neuromotion Labs
Boston, Massachusetts, 02111, United States
Related Publications (2)
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.
PMID: 22574736BACKGROUNDRC Pianta - Unpublished measure, University of Virginia, 1992
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Kahn, PhD
Neuromotion Labs Inc
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2021
First Posted
April 9, 2021
Study Start
May 7, 2021
Primary Completion
October 13, 2021
Study Completion
October 13, 2021
Last Updated
October 20, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
Only Mightier research staff will have access to individual participant data, including family demographics data and data from parent self-report measures.