Oppositional DefiantNCT02662140
Mobile Health Solutions for Behavioral Skill Implementation Through Homework
A study testing Mobile Health Applictaion in people with Oppositional Defiant and Conduct Disorder, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Oppositional Defiant, Conduct Disorder
- What is being tested?
- Mobile Health Applictaion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Conditions
- Oppositional Defiant, Conduct Disorder
- Being tested
- Mobile Health Applictaion
- Medical subject headings
- Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health ApplictaionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobile Health Applictaion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
Demographics Interview
Measured: 4 Months
Measure of Disruptive Behavior Disorder (DBD) Symptoms using DBD Rating Scale
Measured: 4 Months
Measure of Child's Impairment using the Impairment Rating Scale
Measured: 4 Months
Change in quantity and quality of homework measured using the Homework Rating Scale -II
Measured: 4 Months
Change in Homework Adherence and Competence Scales
Measured: 4 Months
Change in Attendance to sessions
Measured: 4 Months
Change in Consumer Satisfaction and Feedback Measured by Weekly Interviews
Measured: 4 Months
Change in behavior measured by the IOWA Conners Oppositional/Defiant Scale
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oppositional DefiantStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary McKay, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662140
- Sponsor's protocol ID
- 14-01854
- Status last verified
- Dec 2016
- First submitted
- 8 Jan 2016
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Solutions for Behavioral Skill Implementation Through Homework
- ClinicalTrials.gov ID
- NCT02662140
- Acronym / sponsor ID
- 14-01854
- Conditions
- Oppositional Defiant, Conduct Disorder
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Health Application Group | Experimental | Behavioral: Mobile Health Applictaionemobile 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health ApplictaionComponent 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 | Behavioural | Mobile Health Application Group |
Primary outcome
Demographics
Time frame: 4 Months
Demographics Interview
Measure of Disruptive Behavior Disorder (DBD) Symptoms using DBD Rating Scale
Time frame: 4 Months
Measure of Child's Impairment using the Impairment Rating Scale
Time frame: 4 Months
Change in quantity and quality of homework measured using the Homework Rating Scale -II
Time frame: 4 Months
Change in Homework Adherence and Competence Scales
Time frame: 4 Months
Change in Attendance to sessions
Time frame: 4 Months
Change in Consumer Satisfaction and Feedback Measured by Weekly Interviews
Time frame: 4 Months
Change in behavior measured by the IOWA Conners Oppositional/Defiant Scale
Time frame: 4 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
Related trials for Oppositional Defiant
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Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
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Digital Therapeutics for Behavior Problems
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Recruiting
Testing a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health
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RecruitingPhase 1/2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary McKay, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Applictaion in people with Oppositional Defiant and Conduct Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics (time frame: 4 Months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.