Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580496
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Adding Printed CBT Materials to a Pediatric Digital Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Examining the Impact of Adding Printed CBT Materials to a Pediatric Digital Emotional Regulation Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal of this study is to demonstrate that engaging with offscreen physical materials that focus on teaching and practicing Cognitive Behavioral Therapy-based skills alongside a digital emotional regulation intervention results in greater symptom improvement in kids than engaging with the digital intervention alone
Participants are 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 childs first play and then complete that survey at 12 weeks post baseline
The pre-post self-report design combined with analyses accounting for engagement with offscreen materials will allow the investigators to observe changes during Mightier use and relate those changes to type of program engagement edited
Participants are 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 childs first play and then complete that survey at 12 weeks post baseline
The pre-post self-report design combined with analyses accounting for engagement with offscreen materials will allow the investigators to observe changes during Mightier use and relate those changes to type of program engagement edited
Detailed Description:
Mightier is an app-based biofeedback videogame platform that utilizes heart rate HR monitoring during gameplay to teach and facilitate practice of emotional regulation skills in children ages 6-14 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 The developers of Mightier have recently created offscreen physical materials that focus on teaching additional Cognitive Behavioral Therapy CBT-based skills and concepts While these materials are based on empirically supported principles it remains unclear whether they impart additional clinical benefit when used in conjunction with the validated video game Investigators seek 1 a better understanding of how offscreen materials may support digital experiences and 2 to provide preliminary evidence that these specific offscreen experiences provide clinical benefit to families rather than solely entertainment benefit
For this proposed study investigators hypothesize the following
1 Caregivers will report family engagement with CBT printed materials
2 Caregivers who indicated high family engagement with printed CBT materials will report larger gains in emotional awareness and emotional regulation than those who did not engage or engaged minimally with CBT printed materials
3 Caregivers will report significantly greater feelings of self-efficacy after using the Mightier program
4 Those who reported high family engagement with printed CBT materials will report higher increases in parenting self-efficacy
For the duration of the 12 week intervention period participants will play Mightier and engage with CBT-based printed materials 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 eg 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 at 12 weeks Participants will only be sent these emails if they are customers of Mightier at the time of follow up
For this proposed study investigators hypothesize the following
1 Caregivers will report family engagement with CBT printed materials
2 Caregivers who indicated high family engagement with printed CBT materials will report larger gains in emotional awareness and emotional regulation than those who did not engage or engaged minimally with CBT printed materials
3 Caregivers will report significantly greater feelings of self-efficacy after using the Mightier program
4 Those who reported high family engagement with printed CBT materials will report higher increases in parenting self-efficacy
For the duration of the 12 week intervention period participants will play Mightier and engage with CBT-based printed materials 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 eg 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 at 12 weeks Participants will only be sent these emails if they are customers of Mightier at the time of follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None