NCT02662140

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

January 8, 2016

Last Update Submit

December 28, 2016

Conditions

Outcome Measures

Primary Outcomes (8)

  • Demographics

    Demographics Interview

    4 Months

  • Measure of Disruptive Behavior Disorder (DBD) Symptoms using DBD Rating Scale

    4 Months

  • Measure of Child's Impairment using the Impairment Rating Scale

    4 Months

  • Change in quantity and quality of homework measured using the Homework Rating Scale -II

    4 Months

  • Change in Homework Adherence and Competence Scales

    4 Months

  • Change in Attendance to sessions

    4 Months

  • Change in Consumer Satisfaction and Feedback Measured by Weekly Interviews

    4 Months

  • Change in behavior measured by the IOWA Conners Oppositional/Defiant Scale

    4 Months

Study Arms (1)

Mobile Health Application Group

EXPERIMENTAL

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.

Behavioral: Mobile Health Applictaion

Interventions

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

Mobile Health Application Group

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Conduct Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Mary McKay, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 25, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 29, 2016

Record last verified: 2016-12

Locations