dHealth Solution for Improving Parent Adherence to Behavioral Treatment for ADHD

NCT04025814 | Completed FDA Device

• 1 other identifier: 19-28558
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (4)

• System Usability Scale

  10-item sale for assessing technology product usability

  Change from baseline on technology usability at 6 months

• Feasibility Rating Scale

  1-5 Likert scale rating of amount of time and level of effort needed to use the tool regularly

  Change from baseline on technology use at 6 months

• Parent Acceptability and Satisfaction Questionnaire

  1-5 Likert scale rating level of engagement, usefulness, and acceptability

  Change from baseline on technology use at 6 months

• Parent adherence/implementation

  5-point Likert scale rating daily use of skills and behavior plans (tracked on application)

  Change from baseline on application use at 2 months

Secondary Outcomes (7)

• Parent Confidence and Motivation to Use Evidence Based Parenting Skills

  Change from baseline on confidence and motivation at 2 months

• Parent Knowledge of Evidence Based Parenting Skills

  Change from baseline on knowledge of EBT at 2 months

• Alabama Parenting Questionnaire

  Change from baseline on parenting skills at 2 months

• Parenting Stress Index

  Change from baseline on parent stress at 2 months

• Barkley Deficit in Executive Functions Scale

  Change from baseline on parent executive functioning at 2 months

Study Arms (2)

dHealth tool and BPT Group

EXPERIMENTAL

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.

Device: CaregiverAssist; Behavioral: Behavioral Parent Training (CLS Parent Group)

BPT Group

EXPERIMENTAL

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.

Behavioral: Behavioral Parent Training (CLS Parent Group)

Interventions

CaregiverAssist DEVICE

CaregiverAssist is a proposed dHealth tool to promote parent adherence and sustained strategy use of evidence-based parenting strategies.

dHealth tool and BPT Group

Behavioral Parent Training (CLS Parent Group) BEHAVIORAL

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

BPT Group; dHealth tool and BPT Group

Eligibility Criteria

• Age: 6 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

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

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Linda Pfiffner, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: August 1, 2020
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)