Expanded Game Squad for Neurodiverse Youth

Physical Activity Clinical Trial

— NDGameSquad  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665415
• Other study ID #: IRB-FY18-19-1
• Status: Completed
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Merrimack College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 31, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Developmental Disabilities
• Developmental Disorder
• Disease
• Health Behavior
• Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
• Personality Disorders
• Physical Activity
• Substance-Related Disorders

Intervention

Behavioral:
• NDGameSquad
The intervention will be delivered within participants' homes. Participants will be provided a gaming console and exergames. Participants will be encouraged to meet a goal of 60 minutes/day of MVPA for the duration of the intervention by playing the exergames at least three times per week and engaging in non-screen based physical activity on other days. Participants will receive a booklet that includes a curriculum for playing weekly challenges. Participants will wear a FitBit during their exergaming sessions. Participants and parents meet bi-weekly with a health coach via video-chat using the exergame console. Sessions will identify and encourage specific physical activity, healthy eating, and healthy sleep habits. At the school site, participants will receive additional check-ins, engagement support, and health curricula from classroom teachers during the first 10 weeks of the intervention.

Locations

Country	Name	City	State
United States	Boston Medical Center Developmental and Behavioral Pediatrics Clinic	Boston	Massachusetts
United States	Marblehead Public Schools	Marblehead	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Merrimack College	Boston Medical Center Developmental and Behavioral Pediatrics Clinic, Marblehead Public Schools, Pennington Biomedical Research Center, University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline 7-day Actigraph MVPA after 10 weeks of intervention	Change in moderate to vigorous physical activity measured via hip-worn Actigraph accelerometer	Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Secondary	Change from baseline BMI after 10 weeks of intervention	Child body mass index change	Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Secondary	Change from baseline blood pressure after 10 weeks of intervention	Child systolic and diastolic blood pressure change	Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Secondary	Change from baseline parent perceptions of child health habits after 10 weeks of intervention	Change in parent report of child sleep, meal-time, screen and physical activity behaviors	Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Secondary	Change from baseline child anxiety symptoms after 10 weeks of intervention	Change in parent and child reported Screen for Childhood Anxiety Related Emotional Disorder (SCARED) questionnaire. The full scale range is 0-82, with five sub-scales (panic disorder range 0-26; generalized anxiety disorder range 0-18; separation anxiety disorder range 0-16; social anxiety disorder range 0-14; school avoidance range 0-8). Higher score values indicate greater experience of symptoms. Total score is the sum of all sub-scores.	Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Secondary	Change in child depression symptoms after 10 weeks of intervention	Change in child reported modified Patient Health Questionnaire for Adolescents (PHQ-A) questionnaire, which assesses symptoms of depression. The scale has a total score range of 0-27 and there are no sub-scales. Greater values indicate greater experience of symptoms.	Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Secondary	Change in child video game use habits	Change in child reported video game use questionnaire	Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)