Attention Deficit Hyperactivity Disorder Clinical Trial
— dHealthOfficial title:
A Digital Health Solution for Improving Parent Adherence to Behavioral Treatment for ADHD
Verified date | November 2023 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 80 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | HALP Clinic, Children's Center at Langley Porter, UCSF | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | System Usability Scale | 10-item sale for assessing technology product usability | Change from baseline on technology usability at 6 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Parent Confidence and Motivation to Use Evidence Based Parenting Skills | 5-point Likert scale of parent rated confidence and motivation | Change from baseline on confidence and motivation at 2 months | |
Secondary | Parent Knowledge of Evidence Based Parenting Skills | Assessed via content question, vignettes, and behavior plans to rate parent knowledge of EBT skills | Change from baseline on knowledge of EBT at 2 months | |
Secondary | Alabama Parenting Questionnaire | Assessment of parenting skills | Change from baseline on parenting skills at 2 months | |
Secondary | Parenting Stress Index | Assessment of parent stress | Change from baseline on parent stress at 2 months | |
Secondary | 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. | Change from baseline on parent executive functioning at 2 months | |
Secondary | Child and Adolescent Symptom Inventory (CASI-V) | Assessment of ADHD and oppositional behaviors | Change from baseline on ADHD and oppositional behaviors at 2 months | |
Secondary | Strengths and Difficulties Questionnaire | Assessment of child impairments | Change from baseline on child impairments at 2 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06129396 -
Effects of Aerobic Exercise Intervention in Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
|
N/A | |
Completed |
NCT04779333 -
Lifestyle Enhancement for ADHD Program 2
|
N/A | |
Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
Completed |
NCT03148782 -
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
|
N/A | |
Completed |
NCT04832737 -
Strength-based Treatment Approach for Adults With ADHD
|
N/A | |
Recruiting |
NCT04631042 -
Developing Brain, Impulsivity and Compulsivity
|
||
Recruiting |
NCT05048043 -
Development of a Game-supported Intervention
|
N/A | |
Completed |
NCT03337646 -
Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism
|
Phase 4 | |
Not yet recruiting |
NCT06080373 -
Formulation-based CBT for Adult Inmates With ADHD: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT02911194 -
a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)
|
N/A | |
Completed |
NCT02477280 -
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance
|
Phase 4 | |
Completed |
NCT02780102 -
Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD
|
N/A | |
Completed |
NCT02390791 -
New Technologies to Help Manage ADHD
|
N/A | |
Completed |
NCT02829970 -
Helping College Students With ADHD Lead Healthier Lifestyles
|
N/A | |
Completed |
NCT02473185 -
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the QbTest
|
Phase 4 | |
Completed |
NCT02555150 -
A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD
|
Phase 3 | |
Recruiting |
NCT04175028 -
Neuromodulation of Executive Function in the ADHD Brain
|
N/A | |
Recruiting |
NCT04296604 -
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
|
N/A | |
Terminated |
NCT02259517 -
An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD
|
N/A | |
Completed |
NCT02580890 -
Role of Transcranial Direct Current Stimulation (tDCS) in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
|
N/A |