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Trial record 36 of 137 for:    Mental Disorders | Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Expanded Game Squad for Neurodiverse Youth (NDGameSquad)

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ClinicalTrials.gov Identifier: NCT03665415
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
University of Massachusetts, Worcester
Pennington Biomedical Research Center
Boston Medical Center Developmental and Behavioral Pediatrics Clinic
Marblehead Public Schools
Information provided by (Responsible Party):
April Bowling, Merrimack College

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.

Condition or disease Intervention/treatment Phase
Physical Activity Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) Health Behavior Developmental Disorder Behavioral: NDGameSquad Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes 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.
Primary Purpose: Prevention
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
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Formative
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 each site (i.e., a total of n=6 in both sites) 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.
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.

Experimental: Pilot 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.
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.

Pilot Waitlist Control
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.
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.




Primary Outcome Measures :
  1. Change from baseline 7-day Actigraph MVPA after 10 weeks of intervention [ Time Frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention) ]
    Change in moderate to vigorous physical activity measured via hip-worn Actigraph accelerometer


Secondary Outcome Measures :
  1. Change from baseline BMI after 10 weeks of intervention [ Time Frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention) ]
    Child body mass index change

  2. Change from baseline blood pressure after 10 weeks of intervention [ Time Frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention) ]
    Child systolic and diastolic blood pressure change

  3. Change from baseline parent perceptions of child health habits after 10 weeks of intervention [ Time Frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention) ]
    Change in parent report of child sleep, meal-time, screen and physical activity behaviors

  4. Change from baseline child anxiety symptoms after 10 weeks of intervention [ Time Frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week 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.

  5. Change in child depression symptoms after 10 weeks of intervention [ Time Frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week 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.

  6. Change in child video game use habits [ Time Frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention) ]
    Change in child reported video game use questionnaire



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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665415


Contacts
Contact: April Bowling, ScD 978-837-5187 bowlinga@merrimack.edu
Contact: Jessica Molignano, JD 978-837-5000 molignanoj@merrimack.edu

Locations
United States, Massachusetts
Marblehead Public Schools Recruiting
Marblehead, Massachusetts, United States, 01945
Contact: April Bowling, ScD    978-837-5187    bowlinga@merrimack.edu   
Contact: James Slavet, PhD    781-639-3100    slavet.james@marbleheadschools.org   
Sponsors and Collaborators
Merrimack College
University of Massachusetts, Worcester
Pennington Biomedical Research Center
Boston Medical Center Developmental and Behavioral Pediatrics Clinic
Marblehead Public Schools

Publications:

Responsible Party: April Bowling, Assistant Professor, Merrimack College
ClinicalTrials.gov Identifier: NCT03665415     History of Changes
Other Study ID Numbers: IRB-FY18-19-1
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Personality Disorders
Developmental Disabilities
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Neurodevelopmental Disorders