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dHealth Solution for Improving Parent Adherence to Behavioral Treatment for ADHD (dHealth)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CaregiverAssist
Behavioral Parent Training (CLS Parent Group)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

6 Years - 85 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Child aged 6-11 (grades 1-5)
  • Identification by school mental health professionals as experiencing challenges with inattention and/or hyperactivity/impulsivity
  • Attending a participating SFUSD elementary school full time in a mainstream classroom
  • Living with a caretaker who is available to participate in treatment
  • Absence of significant visual/hearing impairment, severe language delay, psychosis, pervasive developmental disorder, or global intellectual impairment per school records
  • Significant ADHD symptoms as evidenced by having (i) six or more symptoms of inattention and/or hyperactivity/impulsivity rated as occurring "often" or "very often" by parents, (ii) at least one area of functioning rated as -≥ 3 on the Impairment Rating Scale by parent

Exclusion Criteria:

  • No presence of conditions that are incompatible with this study's treatment including: severe visual or hearing impairment, severe language delay or intellectual impairment, psychosis, pervasive developmental disorder,
  • Child is in an all-day special education classroom (children in these classrooms are frequently receiving intensive behavior modification programs such that the intervention would be expected to require modification for use in these settings)
  • Children planning to change (start or stop) psychotropic medication Note: Children taking medication will be required to meet all entry criteria, including impairment criteria, thus indicating a need for the intervention. Children taking medication for attention or behavior are eligible as long as their medication regimens are stable.

Sites / Locations

  • HALP Clinic, Children's Center at Langley Porter, UCSF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

dHealth tool and BPT Group

BPT Group

Arm Description

Parents and School Mental Health Providers (SMHPs) will participate in a 2-month trial during which they will use a digital Health (dHealth) tool in daily life contexts while receiving BPT, aimed to improve parent adherence sustained use of evidence-based parenting strategies. They will also participate in focus groups and discussions to facilitate the build, design, and use of the dHealth.

Parents and School Mental Health Providers (SMHPs) will participate in a 2-month trial during which they will be receiving BPT without the use of a digital Health (dHealth) tool.

Outcomes

Primary Outcome Measures

System Usability Scale
10-item sale for assessing technology product usability
Feasibility Rating Scale
1-5 Likert scale rating of amount of time and level of effort needed to use the tool regularly
Parent Acceptability and Satisfaction Questionnaire
1-5 Likert scale rating level of engagement, usefulness, and acceptability
Parent adherence/implementation
5-point Likert scale rating daily use of skills and behavior plans (tracked on application)

Secondary Outcome Measures

Parent Confidence and Motivation to Use Evidence Based Parenting Skills
5-point Likert scale of parent rated confidence and motivation
Parent Knowledge of Evidence Based Parenting Skills
Assessed via content question, vignettes, and behavior plans to rate parent knowledge of EBT skills
Alabama Parenting Questionnaire
Assessment of parenting skills
Parenting Stress Index
Assessment of parent stress
Barkley Deficit in Executive Functions Scale
We will use the Barkley Deficits in Executive Functioning Scale for Adults (BDEFS; Barkley, 2011) which is an empirically based tool for evaluating dimensions of adult executive functioning in daily life. We will use the Overall Executive Functioning Total Score which is a sum of all 89 items (each rated on a likert scale from 1 "never or rarely" to 4 "very often" such that higher scores represent greater degrees of executive functioning impairments) and possible values on the Total Score range from 89 to 356.
Child and Adolescent Symptom Inventory (CASI-V)
Assessment of ADHD and oppositional behaviors
Strengths and Difficulties Questionnaire
Assessment of child impairments

Full Information

First Posted
July 17, 2019
Last Updated
October 31, 2022
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04025814
Brief Title
dHealth Solution for Improving Parent Adherence to Behavioral Treatment for ADHD
Acronym
dHealth
Official Title
A Digital Health Solution for Improving Parent Adherence to Behavioral Treatment for ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to develop, refine and preliminarily test a novel and scalable digital health solution designed to address parent adherence barriers in daily life contexts and increase parent's sustained use of evidence-based parenting strategies.
Detailed Description
The study includes the following 3 phases: Discovery phase: During the Discovery phase, we will conduct 1-hour focus groups at school sites with parents (N=8) and school mental health providers (N=4), who are considered major stakeholders and potential users of the dHealth tool. The purpose of these groups is to obtain feedback and guidance on features and procedures in order to maximize the usability and feasibility of the dHealth tool. This design includes participants who have completed a parenting skills treatment (CLS) and thus would be better informed to comment on needs for the augmented treatment. Stakeholders will be queried about their preferences regarding the application layout, tools, content, and features (e.g., reminders, badges). Recorded focus group sessions will be transcribed and coded for themes related to usability and feasibility. Design and Build phases: Feedback from the discovery phase will be incorporated into the design and build phases, during which time prototypes will be put through proof of concept testing with parents and school clinicians who had participated in the discovery phase. Qualitative data will be collected at 2 time points during the design and build phases. Quantitative data will be gathered using the System Usability Scale (SUS) for each component prototype (e.g., description of skill, video examples, interactive activities). A fully functioning application will be completed at the end of the build phase and ready for the test phase. Test Phase: The test phase is a 2-month pilot open trial of the dHealth tool with parents. We will provide the dHealth tool to parents who participated in the prior phases (N=5) as well as a new sample of parents (N=12) who will test the tool with their children in conjunction with the parent's participation in BPT at their school (to test tool utility during the course of treatment). Parents will be advised to use the tool daily to record parenting strategy use and to access information/training as needed. Qualitative semi-structured interviews during and after the trial will assess reactions to the platform (usability, feasibility, acceptability) to inform refinements and identify barriers and facilitators relating to use. Primary outcomes focus on usage metrics with the tool (e.g., frequency of use, module and activity completion, time, repeat activity), reported daily parenting skills use on the tool, and measures of feasibility and acceptability. Application usage analytics will be collected by the mobile application, providing objective descriptives including how often and for how long individuals access the application and each component, as well as how users navigate through the application. This data will be analyzed for patterns associated with tool satisfaction ratings, feasibility, and acceptability ratings and reported skill utilization. Secondary outcomes of parent knowledge, motivation and confidence in using EBT skills; parenting practices, ADHD symptoms and functional outcomes will be assessed before and after tool usage. Randomized Controlled Trial (RCT) Phase: The RCT phase is a 20-month pilot randomized controlled trial of the refined dHealth tool with parents. We will randomly assign groups to receive either the parenting skills training plus the tool (N=5 groups, 30 parents) or parenting skills training without the tool (N=5 groups, 30 parents). Exploratory analyses will examine the potential mediating mechanism of skill utilization (immediate and sustained) for optimizing the association between the dHealth intervention and improved child and parenting outcomes and the potential moderating effect of parent ADHD/EF functioning and internalizing mental health dimensions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dHealth tool and BPT Group
Arm Type
Experimental
Arm Description
Parents and School Mental Health Providers (SMHPs) will participate in a 2-month trial during which they will use a digital Health (dHealth) tool in daily life contexts while receiving BPT, aimed to improve parent adherence sustained use of evidence-based parenting strategies. They will also participate in focus groups and discussions to facilitate the build, design, and use of the dHealth.
Arm Title
BPT Group
Arm Type
Experimental
Arm Description
Parents and School Mental Health Providers (SMHPs) will participate in a 2-month trial during which they will be receiving BPT without the use of a digital Health (dHealth) tool.
Intervention Type
Device
Intervention Name(s)
CaregiverAssist
Intervention Description
CaregiverAssist is a proposed dHealth tool to promote parent adherence and sustained strategy use of evidence-based parenting strategies.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Parent Training (CLS Parent Group)
Intervention Description
Collaborative Life Skills (CLS) program is implemented at school sites by school mental health providers who are trained by University of California San Francisco (UCSF) project staff
Primary Outcome Measure Information:
Title
System Usability Scale
Description
10-item sale for assessing technology product usability
Time Frame
Change from baseline on technology usability at 6 months
Title
Feasibility Rating Scale
Description
1-5 Likert scale rating of amount of time and level of effort needed to use the tool regularly
Time Frame
Change from baseline on technology use at 6 months
Title
Parent Acceptability and Satisfaction Questionnaire
Description
1-5 Likert scale rating level of engagement, usefulness, and acceptability
Time Frame
Change from baseline on technology use at 6 months
Title
Parent adherence/implementation
Description
5-point Likert scale rating daily use of skills and behavior plans (tracked on application)
Time Frame
Change from baseline on application use at 2 months
Secondary Outcome Measure Information:
Title
Parent Confidence and Motivation to Use Evidence Based Parenting Skills
Description
5-point Likert scale of parent rated confidence and motivation
Time Frame
Change from baseline on confidence and motivation at 2 months
Title
Parent Knowledge of Evidence Based Parenting Skills
Description
Assessed via content question, vignettes, and behavior plans to rate parent knowledge of EBT skills
Time Frame
Change from baseline on knowledge of EBT at 2 months
Title
Alabama Parenting Questionnaire
Description
Assessment of parenting skills
Time Frame
Change from baseline on parenting skills at 2 months
Title
Parenting Stress Index
Description
Assessment of parent stress
Time Frame
Change from baseline on parent stress at 2 months
Title
Barkley Deficit in Executive Functions Scale
Description
We will use the Barkley Deficits in Executive Functioning Scale for Adults (BDEFS; Barkley, 2011) which is an empirically based tool for evaluating dimensions of adult executive functioning in daily life. We will use the Overall Executive Functioning Total Score which is a sum of all 89 items (each rated on a likert scale from 1 "never or rarely" to 4 "very often" such that higher scores represent greater degrees of executive functioning impairments) and possible values on the Total Score range from 89 to 356.
Time Frame
Change from baseline on parent executive functioning at 2 months
Title
Child and Adolescent Symptom Inventory (CASI-V)
Description
Assessment of ADHD and oppositional behaviors
Time Frame
Change from baseline on ADHD and oppositional behaviors at 2 months
Title
Strengths and Difficulties Questionnaire
Description
Assessment of child impairments
Time Frame
Change from baseline on child impairments at 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Child aged 6-11 (grades 1-5) Identification by school mental health professionals as experiencing challenges with inattention and/or hyperactivity/impulsivity Attending a participating SFUSD elementary school full time in a mainstream classroom Living with a caretaker who is available to participate in treatment Absence of significant visual/hearing impairment, severe language delay, psychosis, pervasive developmental disorder, or global intellectual impairment per school records Significant ADHD symptoms as evidenced by having (i) six or more symptoms of inattention and/or hyperactivity/impulsivity rated as occurring "often" or "very often" by parents, (ii) at least one area of functioning rated as -≥ 3 on the Impairment Rating Scale by parent Exclusion Criteria: No presence of conditions that are incompatible with this study's treatment including: severe visual or hearing impairment, severe language delay or intellectual impairment, psychosis, pervasive developmental disorder, Child is in an all-day special education classroom (children in these classrooms are frequently receiving intensive behavior modification programs such that the intervention would be expected to require modification for use in these settings) Children planning to change (start or stop) psychotropic medication Note: Children taking medication will be required to meet all entry criteria, including impairment criteria, thus indicating a need for the intervention. Children taking medication for attention or behavior are eligible as long as their medication regimens are stable.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Pfiffner, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
HALP Clinic, Children's Center at Langley Porter, UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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dHealth Solution for Improving Parent Adherence to Behavioral Treatment for ADHD

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