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Behavioral Intervention

Digital Health Solution for ADHD Treatment Adherence (dHealth Trial)

N/A
Waitlist Available
Led By Linda Pfiffner, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child aged 6-11 (grades 1-5)
Child aged 7-11 (grades 2-5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline on child impairments at 2 months
Awards & highlights

dHealth Trial Summary

This trial will develop a new digital health solution to help parents better adhere to evidence-based parenting strategies.

Who is the study for?
This trial is for children aged 6-11 with significant ADHD symptoms, attending a participating SFUSD elementary school in a mainstream classroom. They must have challenges with attention or hyperactivity/impulsivity identified by school mental health professionals and live with a caretaker who can participate in treatment. Children cannot join if they have severe sensory impairments, language delays, psychosis, pervasive developmental disorders, or intellectual impairments.Check my eligibility
What is being tested?
The study tests a digital health solution aimed at helping parents adhere to behavioral treatments for their child's ADHD. It involves using the 'CaregiverAssist' program alongside traditional Behavioral Parent Training (CLS Parent Group) to see if it improves the use of parenting strategies.See study design
What are the potential side effects?
Since this trial focuses on behavioral training and digital solutions rather than medication, there are no direct medical side effects expected. However, participants may experience stress or frustration related to technology use or changes in routine.

dHealth Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is between 6 and 11 years old and in grades 1-5.
Select...
My child is between 7 and 11 years old.

dHealth Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline on adhd and oppositional behaviors at 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline on adhd and oppositional behaviors at 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility Rating Scale
Parent Acceptability and Satisfaction Questionnaire
Parent adherence/implementation
+1 more
Secondary outcome measures
Alabama Parenting Questionnaire
Barkley Deficit in Executive Functions Scale
Child and Adolescent Symptom Inventory (CASI-V)
+4 more

dHealth Trial Design

2Treatment groups
Experimental Treatment
Group I: dHealth tool and BPT GroupExperimental Treatment2 Interventions
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.
Group II: BPT GroupExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,391 Total Patients Enrolled
7 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
770 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Linda Pfiffner, PhDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
583 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
79 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the enrollment criteria for this experiment exclude individuals over 65 years of age?

"Those who plan to participate in this trial must fit within the age range of 6 and 85. Additionally, there are a total 108 trials available for those under 18 years old, while 35 clinical studies have been made accessible to individuals over 65."

Answered by AI

Are there any current vacancies in this research program?

"This trial, which was initially made known to the public on August 1st 2020 and last updated on October 31st 2022 does not seem to be admitting patients presently. Nevertheless, there are 152 additional trials that have open enrollment for human participants at this time."

Answered by AI

Would I be eligible to partake in this clinical experiment?

"This medical trial seeks to recruit 80 subjects between 6 and 85 years of age with Attention Deficit Hyperactivity Disorder (ADHD). To qualify, candidates must be children aged 7-11 attending a participating school in the San Francisco Unified School District full time, without visual/hearing impairments or severe language delays. Additionally, they will require parental support as well as evidence from both parent and teacher that there are at least six symptoms of inattention or hyperactivity/impulsivity rated "often"/"very often", plus one area of functioning rated -≥ 3 on an Impairment Rating Scale by each informant."

Answered by AI

What are the desired outcomes of this research endeavor?

"This research aims to measure the efficacy of implementation, as well as parent adherence. Additionally, upon completion of this trial there will be a determination made in regards to parental confidence and motivation for usage; stress levels experienced by parents; and knowledge pertaining to evidence-based parenting skills. These variables are assessed via a five-point Likert scale at 6 months post baseline evaluation."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Illinois
How old are they?
18 - 65
What site did they apply to?
HALP Clinic, Children's Center at Langley Porter, UCSF
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
dHealth Solution for Improving Parent Adherence to Behavioral Treatment for ADHD
2020. "dHealth Solution for Improving Parent Adherence to Behavioral Treatment for ADHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04025814.
All > Adhd
~3 spots leftby Jun 2024
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