NCT01917838

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 7, 2013

Completed
2.2 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

July 18, 2013

Last Update Submit

February 27, 2020

Conditions

Keywords

Mental Health Services

Outcome Measures

Primary Outcomes (2)

  • DADR Process- HW quantity and quality, Homework Rating Scale-II

    This assessment helps to understand the DADR process and to assess if homework was completed and how much.

    Weekly for 16 weeks; duration of group

  • DADR Proces- Homework Adherence and Competence Scales

    An independent observer will assess level of homework adherence and competence in every session.

    Participants will be tracked up to 16 weeks and feedback will be collected every week.

Secondary Outcomes (5)

  • DBD Symptoms -DBD Rating Scale

    Day 1- 1st contact

  • Children's Impairment Rating Scale

    Day 1- 1st Contact

  • Attendance

    Weekly- duration of the 16 week group

  • IOWA Conners Oppositional/Defiant Scale

    1st contact and at the end of the 16 week group

  • Consumer Satisfaction & Feedback- Treatment Attitude Inventory

    1st contact and at the end of the 16 week group

Study Arms (1)

MFG plus MyMFG

EXPERIMENTAL

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

Interventions

MFG plus MyMFGBEHAVIORAL

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.

MFG plus MyMFG

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \) youth between the ages of 7 to 13 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McSilver Institute for Poverty Policy and Research - New York University Silver School of Social Work

New York, New York, 10003, United States

Location

Related Publications (1)

  • Chacko A, Isham A, Cleek AF, McKay MM. Using mobile health technology to improve behavioral skill implementation through homework in evidence-based parenting intervention for disruptive behavior disorders in youth: study protocol for intervention development and evaluation. Pilot Feasibility Stud. 2016 Sep 20;2:57. doi: 10.1186/s40814-016-0097-4. eCollection 2016.

Study Officials

  • Mary M McKay, PhD

    New York University Silver School of Social Work

    PRINCIPAL INVESTIGATOR
  • Tyrone M Parchment, LMSW

    New York University Silver School of Social Work

    STUDY DIRECTOR
  • Ozge Sensoy-Bahar, PhD

    New York University Silver School of Social Work

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
McSilver Professor of Poverty Studies, Director, McSilver Institute for Poverty Policy and Research

Study Record Dates

First Submitted

July 18, 2013

First Posted

August 7, 2013

Study Start

November 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

March 2, 2020

Record last verified: 2020-02

Locations