Mobile Health Solutions for Behavioral Skill Implementation Through Homework (MHealth)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by NYU Silver School of Social Work
Sponsor:
Information provided by (Responsible Party):
Mary M. McKay, NYU Silver School of Social Work
ClinicalTrials.gov Identifier:
NCT01917838
First received: July 18, 2013
Last updated: August 23, 2013
Last verified: July 2013
  Purpose

The goal of this two-year R34 treatment development grant is to develop a mobile health (mHealth) application that will both advance theory in and clinical practice of homework (HW) implementation.

HW can be described as between-session exercises where the client practices specific skills learned within-session in order to promote skill acquisition, which ultimately leads to improved acute- as well as longer-term therapeutic benefits on targeted outcomes, generalization of treatment effects and maintenance of treatment gains. Despite data demonstrating that HW is critical to achieving maximal benefits from evidence-based treatments, very little theory-driven approaches have been conducted focusing on improving the HW process. Through utilizing self-determination theory as a guiding framework and integrating principles from the field of "gamification" and goal-setting, the aim is to develop a two-component mHealth HW application (My MFG).

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.

The process of the development of My MFG will be guided by the clinic and community development model and iterative software development process to maximize the feasibility and sustainability of My MFG within practice settings often characterized by limited resources. Findings from this study have broad implications for evidence-based treatments for youth and adult mental health disorders that emphasize HW as the link between treatment and improvements in targeted outcomes.


Condition Intervention
Mental Health Wellness 1
Behavioral: MFG plus MyMFG

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mobile Health Solutions for Behavioral Skill Implementation Through Homework

Resource links provided by NLM:


Further study details as provided by NYU Silver School of Social Work:

Primary Outcome Measures:
  • DADR Process- HW quantity and quality, Homework Rating Scale-II [ Time Frame: Weekly for 16 weeks; duration of group ] [ Designated as safety issue: No ]
    This assessment helps to understand the DADR process and to assess if homework was completed and how much.

  • DADR Proces- Homework Adherence and Competence Scales [ Time Frame: Participants will be tracked up to 16 weeks and feedback will be collected every week. ] [ Designated as safety issue: No ]
    An independent observer will assess level of homework adherence and competence in every session.


Secondary Outcome Measures:
  • DBD Symptoms -DBD Rating Scale [ Time Frame: Day 1- 1st contact ] [ Designated as safety issue: No ]
    To assess the severity of behavior problems.

  • Children's Impairment Rating Scale [ Time Frame: Day 1- 1st Contact ] [ Designated as safety issue: No ]
    To assess level of behavioral impairment for child- caregiver reports.

  • Attendance [ Time Frame: Weekly- duration of the 16 week group ] [ Designated as safety issue: No ]
    Attendance will be measured for each participant at every session.

  • IOWA Conners Oppositional/Defiant Scale [ Time Frame: 1st contact and at the end of the 16 week group ] [ Designated as safety issue: No ]
    Caregiver assesses child's oppostitional and defiant behaviors at pre and post treatment.

  • Consumer Satisfaction & Feedback- Treatment Attitude Inventory [ Time Frame: 1st contact and at the end of the 16 week group ] [ Designated as safety issue: No ]
    This is a feedback assesment that will happen at either group or individual consultancy meeting to assess feedback of the MHealth process by parent, target child, and therapist.


Estimated Enrollment: 96
Study Start Date: November 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MFG plus MyMFG

MFG plus MyMFG will be tested and the aim is:

  1. Greater quality of the "Design" and "Do" process rated by therapists, parents, and independent coders.
  2. Greater quantity and quality of HW assignments rated by therapists and parents.
  3. Greater quality of the "Review" process as rated by therapists, parents, and independent coders.
  4. Greater satisfaction with treatment as rated by the parent, target child, and therapists.
Behavioral: MFG plus MyMFG

Specific aim is to utilize mHealth to improve the "Design" and "Do" process of HW within the context of the Family Groups for Youth with Behavioral Difficulties (MFG) intervention, an EBT for DBDs in youth and their families who seek assistance at outpatient mental health clinics in urban communities.

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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1) youth between the ages of 7 to 11 years and an accompanying adult primary caregiver available to participate in the research and intervention activities 2) English speaking youth and adult caregiver and 3) youth meeting criteria for DBD via parent reports based on the Disruptive Behavior Disorder (DBD) rating scales of DSM symptoms and cross-situational impairment as assessed through parent ratings on the Impairment Rating Scale (IRS). Children will be diagnosed with DBD if they meet DSM symptom criteria for DBD by parent report (i.e., at least four symptoms of ODD or 3 symptoms of CD), and impairment ratings indicate at least one impairment domain.

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Exclusion Criteria:

Children will also be excluded if there is:

  • Evidence of psychosis
  • If the youth or adult caregiver presents with emergency psychiatric needs that require services beyond that which can be managed within an outpatient setting (e.g. hospitalization, specialized placement outside the home), active intervention by clinic and research staff to secure what is needed will be made
  • Children will not be excluded if they participate in other psychosocial or pharmacological interventions.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917838

Contacts
Contact: Andrew F. Cleek, PsyD 212-998-9093 andrew.cleek@nyu.edu
Contact: Anil Chacko, PhD 718-997-3237 anil.chacko@qc.cuny.edu

Locations
United States, New York
McSilver Institute of Poverty Policy and Research Not yet recruiting
New York, New York, United States, 10003
Contact: Andrew F Cleek, PsyD    212-998-9093    andrew.cleek@nyu.edu   
Contact: Ashley Fuss, LMSW    212-998-9097    ashley.fuss@nyu.edu   
Sub-Investigator: Andrew F. Cleek, PsyD         
Sponsors and Collaborators
NYU Silver School of Social Work
Investigators
Principal Investigator: Mary M McKay, PhD New York University Silver School of Social Work
  More Information

No publications provided

Responsible Party: Mary M. McKay, McSilver Professor of Poverty Studies, Director, McSilver Institute for Poverty Policy and Research, NYU Silver School of Social Work
ClinicalTrials.gov Identifier: NCT01917838     History of Changes
Other Study ID Numbers: R34MH100407-01
Study First Received: July 18, 2013
Last Updated: August 23, 2013
Health Authority: United States: Federal Government

Keywords provided by NYU Silver School of Social Work:
Mental Health Services

ClinicalTrials.gov processed this record on August 01, 2014