Clinical trial NCT03665415: Expanded Game Squad for Neurodiverse Youth
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Health Behavior
Developmental Disorder
Lead sponsor: Merrimack College
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
name: Pennington Biomedical Research Center
name: Boston Medical Center Developmental and Behavioral Pediatrics Clinic
name: Marblehead Public Schools
First posted: 2018-09-11
Enrollment: 23
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The project will be carried out in three phases: 1) Formative research to implement the intervention with n=6 youth in order to make any modifications necessary before embarking on the full pilot in both sites in the next phase; 2) The pilot intervention comprised of a randomized wait-list controlled pilot intervention at two sites (school and clinic) during the school year; 3) an unsupported follow up period where participants in the school-based intervention will be offered the intervention during the summer months without school staff support. Wait-listed school site participants will also receive the unsupported intervention in this phase.
Primary purpose: PREVENTION

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 overweight/obesity in regular physical activity and virtual health counseling. Game Squad utilizes home exergaming consoles (i.e., 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 MH/DD. 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).

Eligibility criteria: Inclusion Criteria:

* Receiving services either through the BMC-DBP or TIDES programs
* Wi-Fi and TV available in their home environment

Exclusion Criteria:

* Intellectual disability
* Chronic or physically disabling conditions for which strenuous physical activity is contra-indicated or not feasible

Primary outcomes:
measure: Change from baseline 7-day Actigraph MVPA after 10 weeks of intervention
timeFrame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Secondary outcomes:
measure: Change from baseline BMI after 10 weeks of intervention
timeFrame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
measure: Change from baseline blood pressure after 10 weeks of intervention
timeFrame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
measure: Change from baseline parent perceptions of child health habits after 10 weeks of intervention
timeFrame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
measure: Change from baseline child anxiety symptoms after 10 weeks of intervention
timeFrame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
measure: Change in child depression symptoms after 10 weeks of intervention
timeFrame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
measure: Change in child video game use habits
timeFrame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center Developmental and Behavioral Pediatrics Clinic
state: Massachusetts
city: Marblehead
country: United States
facility: Marblehead Public Schools
state: Massachusetts
Study officials:
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