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Mobile Health Solutions for Behavioral Skill Implementation Through Homework

Primary Purpose

Oppositional Defiant, Conduct Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health Applictaion
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oppositional Defiant

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • youth between the ages of 7 to 11 years and an accompanying adult primary caregiver available to participate in the research and intervention activities
  • English speaking youth and adult caregiver and
  • the child should meet criteria for a primary diagnosis of Oppositional Defiant or Conduct Disorder.

Exclusion Criteria:

  • a significant cognitive impairment or emergent psychiatric needs of the caregiver or child that interferes with understanding of program content or informed consent process or requires a higher level of care.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobile Health Application Group

Arm Description

emobile health application will enhance the existing evidence informed curriculum of a Multiple Family Group model (called 4 Rs and 2 Ss for Strengthening Families Model) for families with children who have disruptive behavior disorders. This mobile application consists of two primary components that will support engagement and integration of the model's core concepts in family life. The first component focuses on delivering HW via a highly engaging, multiplayer, interactive, cooperative, and skill-building game platform aimed at improving the "Design" and "Do" process of HW. The second component focuses on targeting factors putatively related to poor HW implementation within the "Do" process.

Outcomes

Primary Outcome Measures

Demographics
Demographics Interview
Measure of Disruptive Behavior Disorder (DBD) Symptoms using DBD Rating Scale
Measure of Child's Impairment using the Impairment Rating Scale
Change in quantity and quality of homework measured using the Homework Rating Scale -II
Change in Homework Adherence and Competence Scales
Change in Attendance to sessions
Change in Consumer Satisfaction and Feedback Measured by Weekly Interviews
Change in behavior measured by the IOWA Conners Oppositional/Defiant Scale

Secondary Outcome Measures

Full Information

First Posted
January 8, 2016
Last Updated
December 28, 2016
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02662140
Brief Title
Mobile Health Solutions for Behavioral Skill Implementation Through Homework
Official Title
Mobile Health Solutions for Behavioral Skill Implementation Through Homework
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to develop a mobile health (mHealth) application that will both advance theory in and clinical practice of homework (HW) implementation. The mobile health application will enhance the existing evidence informed curriculum of a Multiple Family Group model (called 4 Rs and 2 Ss for Strengthening Families Model) for families with children who have disruptive behavior disorders. This mobile application consists of two primary components that will support engagement and integration of the model's core concepts in family life. The first component focuses on delivering homework via a highly engaging, multiplayer, interactive, cooperative, and skill-building game platform aimed at improving the "Design" and "Do" process of homework.The second component focuses on targeting factors putatively related to poor HW implementation within the "Do" process.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oppositional Defiant, Conduct Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Health Application Group
Arm Type
Experimental
Arm Description
emobile health application will enhance the existing evidence informed curriculum of a Multiple Family Group model (called 4 Rs and 2 Ss for Strengthening Families Model) for families with children who have disruptive behavior disorders. This mobile application consists of two primary components that will support engagement and integration of the model's core concepts in family life. The first component focuses on delivering HW via a highly engaging, multiplayer, interactive, cooperative, and skill-building game platform aimed at improving the "Design" and "Do" process of HW. The second component focuses on targeting factors putatively related to poor HW implementation within the "Do" process.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Health Applictaion
Intervention Description
Component 1: Delivering homework via a highly engaging, multiplayer, interactive, cooperative, and skill-building game platform aimed at improving the "Design" and "Do" process of HW. Component 2: Focuses on targeting factors putative related to poor HW implementation within the "Do" process
Primary Outcome Measure Information:
Title
Demographics
Description
Demographics Interview
Time Frame
4 Months
Title
Measure of Disruptive Behavior Disorder (DBD) Symptoms using DBD Rating Scale
Time Frame
4 Months
Title
Measure of Child's Impairment using the Impairment Rating Scale
Time Frame
4 Months
Title
Change in quantity and quality of homework measured using the Homework Rating Scale -II
Time Frame
4 Months
Title
Change in Homework Adherence and Competence Scales
Time Frame
4 Months
Title
Change in Attendance to sessions
Time Frame
4 Months
Title
Change in Consumer Satisfaction and Feedback Measured by Weekly Interviews
Time Frame
4 Months
Title
Change in behavior measured by the IOWA Conners Oppositional/Defiant Scale
Time Frame
4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: youth between the ages of 7 to 11 years and an accompanying adult primary caregiver available to participate in the research and intervention activities English speaking youth and adult caregiver and the child should meet criteria for a primary diagnosis of Oppositional Defiant or Conduct Disorder. Exclusion Criteria: a significant cognitive impairment or emergent psychiatric needs of the caregiver or child that interferes with understanding of program content or informed consent process or requires a higher level of care.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary McKay, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Mobile Health Solutions for Behavioral Skill Implementation Through Homework

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