Mobile Health Solutions for Behavioral Skill Implementation Through Homework

Conduct Disorder Clinical Trial

Official title:

Mobile Health Solutions for Behavioral Skill Implementation Through Homework

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02662140
• Other study ID #: 14-01854
• Status: Withdrawn
• Phase: N/A
• First received: January 8, 2016
• Last updated: December 28, 2016
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Conduct Disorder
• Oppositional Defiant

Intervention

Behavioral:
• Mobile Health Applictaion
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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics	Demographics Interview	4 Months	No
Primary	Measure of Disruptive Behavior Disorder (DBD) Symptoms using DBD Rating Scale		4 Months	No
Primary	Measure of Child's Impairment using the Impairment Rating Scale		4 Months	No
Primary	Change in quantity and quality of homework measured using the Homework Rating Scale -II		4 Months	No
Primary	Change in Homework Adherence and Competence Scales		4 Months	No
Primary	Change in Attendance to sessions		4 Months	No
Primary	Change in Consumer Satisfaction and Feedback Measured by Weekly Interviews		4 Months	No
Primary	Change in behavior measured by the IOWA Conners Oppositional/Defiant Scale		4 Months	No