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Mental Health Wellness 1MHealthNCT01917838

Mobile Health Solutions for Behavioral Skill Implementation Through Homework

A study testing MFG plus MyMFG in people with Mental Health Wellness 1, run by NYU Silver School of Social Work at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 13 yearsHealthy volunteers can take part
Conditions the study is for
Mental Health Wellness 1
What is being tested?
MFG plus MyMFG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteUnited States
Study dates
Nov 2015to Jun 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 13 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 1) 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.
  • -

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • McSilver Institute for Poverty Policy and Research - New York University Silver School of Social Work

    New York, New York, 10003

Other trials in United States

About this study

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).

Read more

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.

Read the detailed description

The aim of the proposed study is to develop a theory-informed mobile health (mHealth) application for urban caregivers attempting to improve their children's oppositional and conduct related difficulties (i.e., disruptive behavior disorders; DBDs). The majority of evidence-based treatments (EBTs) targeting youth DBDs emphasize change in specific parenting/family-level processes empirically linked to the maintenance of DBDs. Existing EBTs frequently include at-home-practice-exercises (i.e., homework; HW) to reinforce parent skill acquisition and maximize use of new skills with children at home. Poor quantity and quality of HW completed by parents significantly attenuates the effect of EBTs. This is a significant limiting-factor in many EBTs attaining full public health impact. Given the robust effect of HW on outcomes from EBTs across a range of behavioral health difficulties and populations, there is a call for moving beyond the question of whether HW is important to questions such as what processes are involved in HW implementation and how best to support these processes. Minimal investigation has been focused on these critical questions.

A model of HW has recently been proposed to better understand the process of HW implementation, as well as guide critically needed supports for at-home practice exercises.

This model proposes four HW processes:

  1. Designing;
  2. Assigning;
  3. Doing, and;
  4. Reviewing.

The DADR model proposes that specific social, cognitive and behavioral factors related to the HW task, as well as to the provider and the adult caregiver may affect the quality of each phase and ultimately to the quantity and quality of HW completed. Methods to better understand, support, and impact these processes are essential to advancing theory and offering solutions to HW completion.

Through features available on smartphones (e.g., camera/video/voice recording; simple message service; internet-access; global positioning system), there are novel methods to interface with and support clients outside of defined treatment sessions. Through the use of these features, mHealth applications can be used to engage, educate, connect, track, and remind clients. These applications can use push (send communications) or pull (client's access tools on their own) mechanisms to engage the client in behavioral change activity. mHealth applications that integrate push and pull methods offer a significant opportunity to enhance outcomes across a range of health and behavioral health challenges and populations.

The goal of this two-year R34 treatment development grant is in response to RFA-MH-13-061 (Harnessing advanced health technologies to drive mental health improvement) to develop a mHealth application that will both advance theory in and clinical practice guided by the DADR model of HW implementation. Specifically we aim 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. To date, efforts at utilizing mHealth within the context of HW have been minimal and have not taken a systematic, theory-driven approach, thereby limiting the advance of knowledge and clinical application. 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 MFG mHealth HW application (My MFG). The first component focuses on delivering MFG HW via a highly engaging, multiplayer, interactive, cooperative, and skill-building game platform aimed at improving the "Design" and "Do" process. 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. The specific aims of this project are to:

  1. Develop My MFG through an iterative process informed by the perspectives of key stakeholders
  2. Determine the impact of MFG plus My MFG relative to MFG-alone on the DADR process and HW quantity and quality. It is hypothesized that the MFG plus My MFG will result in:
  3. Greater quality of the "Design" and "Do" process rated by therapists, parents, and independent coders
  4. Greater quantity and quality of HW assignments rated by therapists and parents
  5. Greater quality of the "Review" process as rated by therapists, parents, and independent coders as a function of improved HW quantity and quality
  6. Greater satisfaction with treatment as rated by the parent, target child, and therapists NIMH has specifically called for acceleration of research to maximize the ability of current treatments to reduce symptoms, improve adherence and functioning while improving quality of and lowering the cost of care. The mHealth application and methods proposed herein serve as systematic, theory-driven approaches to significantly advance understanding of how best to support the HW process-a common element of many EBTs across various disorders and populations-ultimately resulting in greater effectiveness of EBTs, maintenance and generalization of behavioral skills learned during EBTs.
Being tested
MFG plus MyMFG
Keywords
Mental Health Services

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MFG plus MyMFGBehavioural

    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.

Study groups in NCT01917838
Study groupRoleWhat they receive
MFG plus MyMFGExperimentalMFG 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.
Receives: Behavioral: MFG plus MyMFG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Weekly for 16 weeks; duration of group

  2. DADR Proces- Homework Adherence and Competence Scales

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

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

Secondary outcomes (5)
  1. DBD Symptoms -DBD Rating Scale

    To assess the severity of behavior problems.

    Measured: Day 1- 1st contact

  2. Children's Impairment Rating Scale

    To assess level of behavioral impairment for child- caregiver reports.

    Measured: Day 1- 1st Contact

  3. Attendance

    Attendance will be measured for each participant at every session.

    Measured: Weekly- duration of the 16 week group

  4. IOWA Conners Oppositional/Defiant Scale

    Caregiver assesses child's oppostitional and defiant behaviors at pre and post treatment.

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

  5. Consumer Satisfaction & Feedback- Treatment Attitude Inventory

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2013 (estimated)
  2. Study startNov 2015
  3. Primary completionMay 2016
  4. Study completionJun 2016

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01917838
Sponsor's protocol ID
R34MH100407-01
Acronym
MHealth
Status last verified
Feb 2020
First submitted
18 Jul 2013
Last updated
2 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27965873

Questions about this trial

What is this clinical trial studying?

A study testing MFG plus MyMFG in people with Mental Health Wellness 1, run by NYU Silver School of Social Work 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 2 Mar 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

DADR Process- HW quantity and quality, Homework Rating Scale-II (time frame: Weekly for 16 weeks; duration of group). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01917838, which also lists 1 linked publication.

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 2 Mar 2020.

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