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Behavioral Intervention
Telehealth Intervention for Preschool ADHD (PASS Trial)
N/A
Recruiting
Led By Jessica Lunsford-Avery, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post-treatment, 3 months post-treatment
Awards & highlights
PASS Trial Summary
This trial will investigate telehealth for preschoolers with ADHD. Caregivers, pediatric professionals and primary care providers will give insight to improve the intervention. #telehealth #preschoolers #ADHD
Who is the study for?
The PASS trial is for preschoolers aged 3-5 with ADHD and sleep problems, as reported by their caregivers. The child must have certain scores on ADHD and sleep assessments. Caregivers need to speak English, follow instructions, and have internet access for telehealth visits. Children on certain medications or with other psychiatric disorders are excluded.Check my eligibility
What is being tested?
This study tests two telehealth interventions designed to help manage attention issues in preschoolers with ADHD. It includes virtual focus groups of caregivers and professionals to refine the intervention approach during its initial phase.See study design
What are the potential side effects?
Since this trial involves non-medical interventions through telehealth services, traditional medication side effects are not a concern; however, there may be indirect effects related to changes in routine or behavior management strategies.
PASS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately post-treatment, 3 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post-treatment, 3 months post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Sleep Regularity Index (SRI)
Change in caregiver-reported sleep habits as measured by the Short-Form Child Sleep Habits Questionnaire (SF-CSHQ).
Change in clinician-rated ADHD-RS
Secondary outcome measures
Change in comorbid symptoms as measured by Child Behavioral Checklist for Ages 1½ to 5(CBCL)
Change in parenting stress as measured by the Parenting Stress Scale
Change in parenting style as measured by the Alabama Parenting Questionnaire
+3 moreOther outcome measures
Acceptability as measured by the Satisfaction with Therapy and Therapist Scale (STTS-R).
Adherence to between-session practice.
Feasibility of Randomization
+6 morePASS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PASS Arm1Experimental Treatment1 Intervention
Caregivers will receive sessions of evidence-based behavioral parent training which focuses on improving behaviors, such as establishing daytime and bedtime routines, through enhancement of positive parenting skills, including modifying antecedents, applying/withdrawing positive attention as a consequence, and shaping behavior using salient rewards.
Group II: PASS Arm2Active Control1 Intervention
Caregivers will receive sessions of evidence-based behavioral parent training which focuses on improving behaviors, including in home and public settings, through enhancement of positive parenting skills, including modifying antecedents, applying/withdrawing positive attention as a consequence, and shaping behavior using salient rewards.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telehealth Intervention
2006
N/A
~450
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,472 Total Patients Enrolled
3 Trials studying Mental Health
272 Patients Enrolled for Mental Health
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,655 Total Patients Enrolled
17 Trials studying Mental Health
4,573 Patients Enrolled for Mental Health
Jessica Lunsford-Avery, PhDPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is between 3 to 5 years old.My child has moderate to severe sleep problems and scored 30 on a sleep survey.My child is currently taking medication for attention, mood, or sleep.My child has a psychiatric condition other than ADHD, autism, or intellectual disability and is receiving treatment.My caregiver is willing and able to follow the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: PASS Arm2
- Group 2: PASS Arm1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research study accept adults as participants?
"The study is open to those between the age of 3 and 5 years old."
Answered by AI
Is this clinical trial actively searching for participants?
"This clinical study is not presently enrolling any participants; this was last confirmed by an update on May 8th, 2023. Despite its current status, there are currently 151 other trials actively recruiting patients."
Answered by AI
Are there any specific criteria for becoming a participant in this clinical trial?
"Eligibility for this clinical trial necessitates that participants have good mental health and be between the ages of 3 to 5 years old. The team needs approximately 44 volunteers in total."
Answered by AI
What is the overarching purpose of this research endeavor?
"This trial aims to observe changes in sleep habits, parenting stress, comorbid symptoms, and midpoint of slumber as evaluated by the Short-Form Child Sleep Habits Questionnaire (SF-CSHQ), Parenting Stress Scale (PSS) with a 5-point Likert Scale from Strongly disagree to Strongly Agree, Child Behavioral Checklist for Ages 1½ to 5(CBCL) via 3-point Likert Scale Not True - Very True or Often True., and actigraphy collected over 7 days. These metrics will be measured at Baseline, immediately post treatment period and three months after the"
Answered by AI
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