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

27 lutego 2020 zaktualizowane przez: Mary M. McKay, NYU Silver School of Social Work

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.

Przegląd badań

Status

Zakończony

Interwencja / Leczenie

Szczegółowy opis

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:

    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 as a function of improved HW quantity and quality
    4. 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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

96

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • New York
      • New York, New York, Stany Zjednoczone, 10003
        • McSilver Institute for Poverty Policy and Research - New York University Silver School of Social Work

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

7 lat do 13 lat (Dziecko)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

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.

-

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.

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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
DADR Process- HW quantity and quality, Homework Rating Scale-II
Ramy czasowe: Weekly for 16 weeks; duration of group
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
Ramy czasowe: Participants will be tracked up to 16 weeks and feedback will be collected every week.
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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
DBD Symptoms -DBD Rating Scale
Ramy czasowe: Day 1- 1st contact
To assess the severity of behavior problems.
Day 1- 1st contact
Children's Impairment Rating Scale
Ramy czasowe: Day 1- 1st Contact
To assess level of behavioral impairment for child- caregiver reports.
Day 1- 1st Contact
Attendance
Ramy czasowe: Weekly- duration of the 16 week group
Attendance will be measured for each participant at every session.
Weekly- duration of the 16 week group
IOWA Conners Oppositional/Defiant Scale
Ramy czasowe: 1st contact and at the end of the 16 week group
Caregiver assesses child's oppostitional and defiant behaviors at pre and post treatment.
1st contact and at the end of the 16 week group
Consumer Satisfaction & Feedback- Treatment Attitude Inventory
Ramy czasowe: 1st contact and at the end of the 16 week group
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.
1st contact and at the end of the 16 week group

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Mary M McKay, PhD, New York University Silver School of Social Work
  • Dyrektor Studium: Tyrone M Parchment, LMSW, New York University Silver School of Social Work
  • Dyrektor Studium: Ozge Sensoy-Bahar, PhD, New York University Silver School of Social Work

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 listopada 2015

Zakończenie podstawowe (Rzeczywisty)

1 maja 2016

Ukończenie studiów (Rzeczywisty)

1 czerwca 2016

Daty rejestracji na studia

Pierwszy przesłany

18 lipca 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 sierpnia 2013

Pierwszy wysłany (Oszacować)

7 sierpnia 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 marca 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 lutego 2020

Ostatnia weryfikacja

1 lutego 2020

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • R34MH100407-01 (Grant/umowa NIH USA)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Zdrowie psychiczne Wellness 1

Badania kliniczne na MFG plus MyMFG

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