Ignite Creation Date:
2024-05-06 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03665415
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2018-09-05
Brief Title:
Expanded Game Squad for Neurodiverse Youth
Sponsor:
Merrimack College
Organization:
Merrimack College
Study Overview
Official Title:
Engaging Children With Mental Health and Developmental Disabilities and Their Parents to Adopt a Healthy Lifestyle Piloting the Game Squad Home Exergaming Virtual Health Coaching Intervention
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NDGameSquad
Brief Summary:
The proposed study will pilot the use of an adapted Game Squad intervention aimed at improving physical activity and other important health behaviors nutrition sleep hygiene screen time habits for children and adolescents receiving special education supports for behavioral health challenges or who are served by the Boston Medical Center Developmental and Behavioral Pediatrics BMC-DBP clinic
Detailed Description:
The significant health disparities that exist among people with mental health conditions MH and developmental disabilities DD including autism spectrum disorder ASD have been documented through research and clinical practice The majority of studies have focused on adults with these conditions but due to the efforts of agencies such as the Maternal Child Health Bureau the health disparities experienced by youth with MH and DD are increasingly recognized These youth are more likely to be overweight and obese than their typically developing TD counterparts have higher cardio-metabolic risk factors and have lower levels of health-related fitness These conditions can be partly attributed to the low physical activity levels and poor diet quality that have been observed in these populations Multiple barriers that operate at the individual community and societal levels limit opportunities for these youth to achieve good health and thus there is an urgent need for health promotion interventions to address these disparities One novel way to address these barriers is to explore the use of virtual methods adapted specifically for this population to reach these children and families in their homes while also investigating viable venues through which such interventions can be delivered and supported if necessary
This study seeks to pilot a virtual health coaching and exercise program aimed at addressing modifiable lifestyle factors that can lead to improved health and well-being for youth with MH and DD The Game Squad Home Exergaming program originally developed by the Pennington Biomedical Research Center is a theoretically-guided and evidence-based intervention that has shown effectiveness at engaging parents and children with overweightobesity in regular physical activity and virtual health counseling Game Squad utilizes home exergaming consoles ie Kinect for Xbox video games that require physical activity for gameplay for both caregiver and child exercise sessions as well as to deliver virtual health counseling sessions to participants These virtual health counseling sessions were aimed at improving non-exergame related physical activity Importantly during a recent RCT involving a socio-economically and racially diverse population over a six-month period the intervention yielded clinically significant reductions in BMI z-score and cardiovascular disease risk factors as well as increased moderate to vigorous physical activity MVPA
The proposed project seeks to determine whether the Game Squad intervention is acceptable and engaging to children and adolescents with MH and DD adapt the health counseling sessions to encompass additional health behaviors and meet the needs of this population as well as to assess feasibility of implementation through both a school-based program and a specialized clinic for children with MHDD This is achieved through innovative partnerships with several key collaborators Merrimack College the Pennington Biomedical Research Center the Therapeutic Intervention Designed for Educational Success Program TIDES program a public school special education collaborative in several north shore communities in Massachusetts and the developmental-behavioral pediatrics clinic at Boston Medical Center BMC-DBP a clinical site associated with the MCHB-funded Developmental Pediatrics Research Network DBP-NET
This study seeks to pilot a virtual health coaching and exercise program aimed at addressing modifiable lifestyle factors that can lead to improved health and well-being for youth with MH and DD The Game Squad Home Exergaming program originally developed by the Pennington Biomedical Research Center is a theoretically-guided and evidence-based intervention that has shown effectiveness at engaging parents and children with overweightobesity in regular physical activity and virtual health counseling Game Squad utilizes home exergaming consoles ie Kinect for Xbox video games that require physical activity for gameplay for both caregiver and child exercise sessions as well as to deliver virtual health counseling sessions to participants These virtual health counseling sessions were aimed at improving non-exergame related physical activity Importantly during a recent RCT involving a socio-economically and racially diverse population over a six-month period the intervention yielded clinically significant reductions in BMI z-score and cardiovascular disease risk factors as well as increased moderate to vigorous physical activity MVPA
The proposed project seeks to determine whether the Game Squad intervention is acceptable and engaging to children and adolescents with MH and DD adapt the health counseling sessions to encompass additional health behaviors and meet the needs of this population as well as to assess feasibility of implementation through both a school-based program and a specialized clinic for children with MHDD This is achieved through innovative partnerships with several key collaborators Merrimack College the Pennington Biomedical Research Center the Therapeutic Intervention Designed for Educational Success Program TIDES program a public school special education collaborative in several north shore communities in Massachusetts and the developmental-behavioral pediatrics clinic at Boston Medical Center BMC-DBP a clinical site associated with the MCHB-funded Developmental Pediatrics Research Network DBP-NET
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None