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Expanded Game Squad for Neurodiverse Youth (NDGameSquad)

Primary Purpose

Physical Activity, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Health Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NDGameSquad
Sponsored by
Merrimack College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Activity

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Boston Medical Center Developmental and Behavioral Pediatrics Clinic
  • Marblehead Public Schools

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Other

Arm Label

Formative

Pilot Intervention

Pilot Waitlist Control

Arm Description

This stage represents an initial formative phase to implement the NDGame Squad intervention with small samples of youth in order to make any modifications necessary before embarking on the full pilot in both sites in the next phase. Three (n=3) participants from the school site only will participate in an initial 4-week Game Squad intervention in the first formative phase. Participant feedback including barriers to engagement and suggestions for improvements will be obtained via parent/caregiver and child interviews post-intervention.

Participants in the pilot intervention arm will receive either 10 or 14 weeks of the NDGameSquad intervention. School site participants will receive 10 weeks during the school year, followed by another 4 weeks during summer vacation. Clinic site participants will receive 10 weeks only.

Participants at both sites randomized to the waitlist control arm will be asked to maintain current physical activity levels during the first 10-week period. They will then be provided the intervention equipment and training. School site control arm participants will then participate in a 4-week, unsupported summer NDGame Squad intervention. Clinic site control arm participants will not be required to participate in the NDGameSquad intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline BMI after 10 weeks of intervention
Child body mass index change
Change from baseline blood pressure after 10 weeks of intervention
Child systolic and diastolic blood pressure change
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
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.
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.
Change in child video game use habits
Change in child reported video game use questionnaire

Full Information

First Posted
September 5, 2018
Last Updated
February 18, 2020
Sponsor
Merrimack College
Collaborators
University of Massachusetts, Worcester, Pennington Biomedical Research Center, Boston Medical Center Developmental and Behavioral Pediatrics Clinic, Marblehead Public Schools
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1. Study Identification

Unique Protocol Identification Number
NCT03665415
Brief Title
Expanded Game Squad for Neurodiverse Youth
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Merrimack College
Collaborators
University of Massachusetts, Worcester, Pennington Biomedical Research Center, Boston Medical Center Developmental and Behavioral Pediatrics Clinic, Marblehead Public Schools

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Health Behavior, Developmental Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants cannot be blinded to assignment. Objective outcomes (physical activity, height, weight, blood pressure) will be collected by masked assessors. The primary investigator and all data analysts will be blinded to participant assignment.
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Formative
Arm Type
Other
Arm Description
This stage represents an initial formative phase to implement the NDGame Squad intervention with small samples of youth in order to make any modifications necessary before embarking on the full pilot in both sites in the next phase. Three (n=3) participants from the school site only will participate in an initial 4-week Game Squad intervention in the first formative phase. Participant feedback including barriers to engagement and suggestions for improvements will be obtained via parent/caregiver and child interviews post-intervention.
Arm Title
Pilot Intervention
Arm Type
Experimental
Arm Description
Participants in the pilot intervention arm will receive either 10 or 14 weeks of the NDGameSquad intervention. School site participants will receive 10 weeks during the school year, followed by another 4 weeks during summer vacation. Clinic site participants will receive 10 weeks only.
Arm Title
Pilot Waitlist Control
Arm Type
Other
Arm Description
Participants at both sites randomized to the waitlist control arm will be asked to maintain current physical activity levels during the first 10-week period. They will then be provided the intervention equipment and training. School site control arm participants will then participate in a 4-week, unsupported summer NDGame Squad intervention. Clinic site control arm participants will not be required to participate in the NDGameSquad intervention.
Intervention Type
Behavioral
Intervention Name(s)
NDGameSquad
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline 7-day Actigraph MVPA after 10 weeks of intervention
Description
Change in moderate to vigorous physical activity measured via hip-worn Actigraph accelerometer
Time Frame
Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Secondary Outcome Measure Information:
Title
Change from baseline BMI after 10 weeks of intervention
Description
Child body mass index change
Time Frame
Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Title
Change from baseline blood pressure after 10 weeks of intervention
Description
Child systolic and diastolic blood pressure change
Time Frame
Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Title
Change from baseline parent perceptions of child health habits after 10 weeks of intervention
Description
Change in parent report of child sleep, meal-time, screen and physical activity behaviors
Time Frame
Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Title
Change from baseline child anxiety symptoms after 10 weeks of intervention
Description
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.
Time Frame
Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Title
Change in child depression symptoms after 10 weeks of intervention
Description
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.
Time Frame
Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Title
Change in child video game use habits
Description
Change in child reported video game use questionnaire
Time Frame
Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Boston Medical Center Developmental and Behavioral Pediatrics Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Marblehead Public Schools
City
Marblehead
State/Province
Massachusetts
ZIP/Postal Code
01945
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared.
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