Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05652127 |
Other study ID # |
NML-2109 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 9, 2023 |
Est. completion date |
June 30, 2025 |
Study information
Verified date |
March 2023 |
Source |
Neuromotion Labs |
Contact |
Alyssa Peechatka, PhD |
Phone |
8145743458 |
Email |
alyssa.peechatka[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The primary goal of this study is to demonstrate that digital mental health interventions for
children, such as Mightier, can have an impact on caregiver functioning, including parenting
stress, overall wellbeing, and work engagement.
Participants will be caregivers of children who are using Mightier, a video-game based heart
rate biofeedback intervention used to build emotion regulation. Caregivers will be asked to
complete a short survey prior to their child's first play and then complete that survey two
more times, at 8 weeks and 12 weeks post baseline.
The pre-post self report design will allow us to observe changes during Mightier use and
relate those changes to overall engagement with the intervention.
Description:
Providing care for children with mental illness is associated with significant caregiver
burden that manifests in physical, psychological, and social ways. Caregiver burden is
largely associated with child symptom severity. As such, reducing child symptom severity
should reduce caregiver burden. Yet, caregiver burden is not commonly assessed as an outcome
of mental health interventions and little is known about the impact of child-focused novel
digital mental health interventions on caregiver burden.
Mightier is an app-based biofeedback video game platform that utilizes heart rate (HR)
monitoring during game play to teach and facilitate practice of emotional regulation skills
in children. The effectiveness of Mightier has been supported through several studies in
children ages 8-18, specifically reducing symptoms of aggression, oppositional behavior, and
parental stress. While prior work has supported that Mightier as a child-based intervention
also decreases parent stress, we have not examined if child use of Mightier meaningfully
impacts caregiver wellbeing, or if these changes translate to changes in work engagement or
absenteeism. The proposed study will be a single arm trial where parents and caregivers who
have purchased Mightier will complete baseline and follow up self-report measures assessing
presenteeism, absenteeism, parenting stress, and overall wellbeing.
For this proposed study we hypothesize the following:
1. Participants will report significant reduction in parent stress and absenteeism and a
significant increase in overall wellbeing and presenteeism.
2. Changes in participant stress will be negatively associated with child minutes of
Mightier use and changes in participant wellbeing will be positively associated with
child minutes of Mightier use.
3. Children of participants who report positive change in work productivity (increases in
presenteeism or decreases in absenteeism) will have used Mightier significantly more
than those who do not report positive change.
For the duration of the 8-12 week intervention period, participants will play Mightier and
engage with Mightier parent content ad libitum. They will not receive any special
instructions or recommendations outside of those provided to all Mightier families.
Consistent with any other family using Mightier, participating families will be free to
engage with or deny all programming associated with Mightier (e.g. email updates and other
support). All individuals engaging with participating families to facilitate the standard
Mightier experience will be blinded to their participation in research.
Participating families will be contacted via email to complete follow-up measures. These
emails will be sent 1) 8 weeks after participants complete the first assessment and 2) 12
weeks after participants complete their first assessment. Participants will be sent the 12
week follow up email regardless of 8 week follow up assessment completion. Participants will
only be sent these emails if they are customers of Mightier at the time of follow up.