Clinical trial NCT04025814: dHealth Solution for Improving Parent Adherence to Behavioral Treatment for ADHD
Official title: A Digital Health Solution for Improving Parent Adherence to Behavioral Treatment for ADHD
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. 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.
2. 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.
3. 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.
4. 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.

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.

Primary outcomes:
measure: System Usability Scale
timeFrame: Change from baseline on technology usability at 6 months
measure: Feasibility Rating Scale
timeFrame: Change from baseline on technology use at 6 months
measure: Parent Acceptability and Satisfaction Questionnaire
timeFrame: Change from baseline on technology use at 6 months
measure: Parent adherence/implementation
timeFrame: Change from baseline on application use at 2 months
Secondary outcomes:
measure: Parent Confidence and Motivation to Use Evidence Based Parenting Skills
timeFrame: Change from baseline on confidence and motivation at 2 months
measure: Parent Knowledge of Evidence Based Parenting Skills
timeFrame: Change from baseline on knowledge of EBT at 2 months
measure: Alabama Parenting Questionnaire
timeFrame: Change from baseline on parenting skills at 2 months
measure: Parenting Stress Index
timeFrame: Change from baseline on parent stress at 2 months
measure: Barkley Deficit in Executive Functions Scale
timeFrame: Change from baseline on parent executive functioning at 2 months
measure: Child and Adolescent Symptom Inventory (CASI-V)
timeFrame: Change from baseline on ADHD and oppositional behaviors at 2 months
measure: Strengths and Difficulties Questionnaire
timeFrame: Change from baseline on child impairments at 2 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: HALP Clinic, Children's Center at Langley Porter, UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Linda Pfiffner, PhD
role: PRINCIPAL_INVESTIGATOR
References: