Expanded Game Squad for Neurodiverse Youth

NCT03665415 | Completed

• 1 other identifier: IRB-FY18-19-1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from baseline BMI after 10 weeks of intervention

  Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)

• Change from baseline blood pressure after 10 weeks of intervention

  Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)

• Change from baseline parent perceptions of child health habits after 10 weeks of intervention

  Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)

• Change from baseline child anxiety symptoms after 10 weeks of intervention

  Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)

• Change in child depression symptoms after 10 weeks of intervention

  Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)

Study Arms (3)

Formative

OTHER

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.

Behavioral: NDGameSquad

Pilot Intervention

EXPERIMENTAL

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

Pilot Waitlist Control

OTHER

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

Interventions

NDGameSquad BEHAVIORAL

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.

Formative; Pilot Intervention; Pilot Waitlist Control

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Merrimack College: lead
• University of Massachusetts, Worcester: collaborator
• Pennington Biomedical Research Center: collaborator
• Boston Medical Center Developmental and Behavioral Pediatrics Clinic: collaborator
• Marblehead Public Schools: collaborator

Study Sites (2)

Boston Medical Center Developmental and Behavioral Pediatrics Clinic

Boston, Massachusetts, 02118, United States

Location

Marblehead Public Schools

Marblehead, Massachusetts, 01945, United States

Location

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MeSH Terms

Conditions

Motor Activity; Depression; Psychotic Disorders; Personality Disorders; Substance-Related Disorders; Health Behavior; Developmental Disabilities

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders; Neurodevelopmental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 11, 2018
• Study Start: November 6, 2018
• Primary Completion: August 15, 2019
• Study Completion: December 31, 2019
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)