StressNCT05652127
Mightier Play and Caregiver Stress and Wellbeing
A study testing Mightier in people with Stress, run by Neuromotion Labs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Mightier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 19 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent or caregivers have a child engaging with the heart rate biofeedback intervention Mightier
- Parent or caregivers reside in the United States
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Impact of Child Mightier Play on Caregiver Stress and Wellbeing
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.
Read the 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:
- Participants will report significant reduction in parent stress and absenteeism and a significant increase in overall wellbeing and presenteeism.
- 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.
- 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.
- Conditions
- Stress
- Being tested
- Mightier
- Keywords
- Parent, Stress, Wellbeing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MightierOther
Mightier is an app-based biofeedback video game that utilizes heart rate (HR) monitoring during game play to teach and facilitate practice of emotional regulation skills in children ages 6-14
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Child play of Mightier | Experimental | Ad lib child biofeedback video game play in home Receives: Other: Mightier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Stress Scale
The Parental Stress Scale is an 18-item questionnaire assessing parents' feelings about their parenting role, including both positive and negative aspects of parenthood. Scores range from 18 (lower stress) to 90 (higher stress).
Measured: 12 weeks
Secondary outcomes (2)
The Flourishing Scale
The Flourishing Scale is a brief 8-item measure of self-perceived success in important areas of functioning such as relationships, self-esteem, purpose, and optimism. Scores range from 8 to 56, where high scores represent greater levels of self-perceived success.
Measured: 12 weeks
Caregiver work and valued activities engagement
1-5 items (depending on current employment status) measuring work absenteeism, work engagement, and valued activities engagement. The first question is an open ended numerical input of workdays missed to provide behavioral or mental health support to their child. The 4 following questions are Leikert-type questions ranging from strongly agree to strongly disagree, with strongly agree representing greater impairment of function. These questions have not been independently validated and are not a part of a formalized scale.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start9 Jan 2023
- Primary completion19 Nov 2023
- Study completion19 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromotion Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Alyssa Peechatka, Neuromotion Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652127
- Sponsor's protocol ID
- NML-2109
- Status last verified
- Jul 2024
- First submitted
- 7 Dec 2022
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Child Mightier Play on Caregiver Stress and Wellbeing
- ClinicalTrials.gov ID
- NCT05652127
- Acronym / sponsor ID
- NML-2109
- Conditions
- Stress
- Keywords
- Parent, Stress, Wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Neuromotion LabsIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 19 Nov 2023 (actual)
- Study completion
- 19 Nov 2023 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Participants will report significant reduction in parent stress and absenteeism and a significant increase in overall wellbeing and presenteeism.
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Child play of Mightier | Experimental | Other: MightierAd lib child biofeedback video game play in home |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parent or caregivers have a child engaging with the heart rate biofeedback intervention Mightier
- Parent or caregivers reside in the United States
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MightierMightier is an app-based biofeedback video game that utilizes heart rate (HR) monitoring during game play to teach and facilitate practice of emotional regulation skills in children ages 6-14 | Other | Intervention: Child play of Mightier |
Primary outcome
Parental Stress Scale
Time frame: 12 weeks
The Parental Stress Scale is an 18-item questionnaire assessing parents' feelings about their parenting role, including both positive and negative aspects of parenthood. Scores range from 18 (lower stress) to 90 (higher stress).
2 secondary outcomes
The Flourishing Scale
Time frame: 12 weeks
Caregiver work and valued activities engagement
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mightier in people with Stress, run by Neuromotion Labs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Stress Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.