Clinical trial NCT05652127: Mightier Play and Caregiver Stress and Wellbeing
Official title: Examining the Impact of Child Mightier Play on Caregiver Stress and Wellbeing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Parent
Stress
Wellbeing
Lead sponsor: Neuromotion Labs
Sponsor class: INDUSTRY
First posted: 2022-12-15
Enrollment: 392
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: As a single arm study all participants' children will receive a game-based biofeedback intervention. They are encouraged to engage with the intervention in an entirely self-directed manner.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Parent or caregivers have a child engaging with the heart rate biofeedback intervention Mightier
* Parent or caregivers reside in the United States

Exclusion Criteria:

* None

Primary outcomes:
measure: Parental Stress Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: The Flourishing Scale
timeFrame: 12 weeks
measure: Caregiver work and valued activities engagement
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Neuromotion Inc
state: Massachusetts
Study officials:
References: