44 Participants Needed

Telehealth Intervention for Preschool ADHD

(PASS Trial)

CS
JL
MG
Overseen ByMatt Gibson
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will be investigating two telehealth interventions for preschoolers with ADHD. The study is divided into two Aims. During Aim 1, caregivers of preschoolers with attention concerns, pediatric behavioral health professionals, and pediatric primary care providers will take part in two virtual focus groups to provide their perspective on ways to improve the telehealth intervention being evaluated.

Will I have to stop taking my current medications?

Yes, children currently using stimulant medication, other psychotropics, or medications for sleep cannot participate in the trial.

Is telehealth intervention for preschool ADHD safe for humans?

The research indicates that telehealth interventions, including online programs and virtual clinics for ADHD, have shown high usability and parental satisfaction, suggesting they are generally safe for use in humans.12345

How is the Telehealth Intervention for Preschool ADHD different from other treatments?

The Telehealth Intervention for Preschool ADHD is unique because it uses virtual platforms to deliver behavioral therapy and caregiver training, making it more accessible and convenient compared to traditional in-person treatments. This approach can help overcome barriers such as geographical limitations and scheduling conflicts, providing a flexible option for families.12467

What data supports the effectiveness of the treatment Telehealth Intervention for Preschool ADHD?

Research shows that telehealth services can effectively manage ADHD symptoms in children, with studies indicating improvements in caregiver stress and child behavior when using telehealth models. Additionally, transitioning to teletherapy during the COVID-19 pandemic maintained or improved progress in early intervention services, suggesting telehealth is a viable option for delivering therapy.14689

Who Is on the Research Team?

JL

Jessica Lunsford-Avery, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child is between 3 to 5 years old.
Parent/caregiver must have ability to speak, read, and write in English
My child has moderate to severe sleep problems and scored 30 on a sleep survey.
See 4 more

Exclusion Criteria

My child is currently taking medication for attention, mood, or sleep.
Child with suspected obstructive sleep apnea or restless legs syndrome (via screening questionnaires)
Parent/caregiver are not currently participating in another parent training intervention and have not previously participated in another parent training intervention in the past 6 months.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Baseline
1 visit (virtual)

Treatment

Caregivers participate in one of two 9-week telehealth interventions focusing on behavioral parent training

9 weeks
3 visits (virtual)

Follow-up

Participants are monitored for changes in ADHD symptoms, sleep habits, and psychosocial function post-treatment

3 months
2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Telehealth Intervention
Trial Overview 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.
How Is the Trial Designed?
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.

Telehealth Intervention is already approved in United States for the following indications:

🇺🇸
Approved in United States as Telehealth Intervention for:
  • Attention Deficit Hyperactivity Disorder (ADHD) in preschoolers

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

A study of 93 children showed that transitioning from in-person to virtual therapeutic services during the COVID-19 pandemic maintained progress in early intervention (EI) services, indicating that telehealth can be effective.
Specifically, children receiving speech therapy demonstrated significant improvement in goal achievement scores when comparing in-person (3.00) to virtual sessions (3.33), suggesting that teletherapy can be a viable alternative to traditional methods.
Comparison of Goal Achievement When Transitioning from In-Person Therapy to Teletherapy in Westchester County Early Intervention Program Due to the COVID-19 Pandemic.De Leon, IC., Philipps, J., Yoegel, M., et al.[2022]
Telemedicine interventions for pediatric ADHD, involving methods like computerized training and videoconferencing, showed significant improvements in inattention/cognitive function (SMD = 0.26), hyperactivity/impulsivity (SMD = 0.29), and oppositional behaviors (SMD = 0.72) based on a systematic review of 12 studies with 708 participants.
Overall, while telemedicine treatments demonstrated small to moderate efficacy in managing ADHD symptoms, the satisfaction with these treatments was generally higher among parents compared to teachers, indicating a potential difference in perception of treatment effectiveness.
A meta-analysis on the effect of telemedicine on the management of attention deficit and hyperactivity disorder in children and adolescents.Bemanalizadeh, M., Yazdi, M., Yaghini, O., et al.[2021]
A scoping review of 16 studies found that virtual rehabilitation interventions for preschoolers, mainly targeting language difficulties, are primarily delivered by speech-language pathologists and audiologists using platforms like Skype or Zoom on a weekly basis.
The review highlights the importance of various technological features and engaging activities in these virtual sessions, suggesting that these factors are crucial for effective intervention delivery and engagement in young children.
A scoping review of virtual synchronous intervention studies in preschool rehabilitation.Hatherly, K., Glista, D., Testani, D., et al.[2022]

Citations

Comparison of Goal Achievement When Transitioning from In-Person Therapy to Teletherapy in Westchester County Early Intervention Program Due to the COVID-19 Pandemic. [2022]
A meta-analysis on the effect of telemedicine on the management of attention deficit and hyperactivity disorder in children and adolescents. [2021]
A scoping review of virtual synchronous intervention studies in preschool rehabilitation. [2022]
Effectiveness of a telehealth service delivery model for treating attention-deficit/hyperactivity disorder: a community-based randomized controlled trial. [2018]
The Children's Attention-Deficit Hyperactivity Disorder Telemental Health Treatment Study: Caregiver Outcomes. [2022]
Self-directed or therapist-led parent training for children with attention deficit hyperactivity disorder? A randomized controlled non-inferiority pilot trial. [2022]
ADHDCoach-a virtual clinic for parents of children with ADHD: Development and usability study. [2023]
Pre-school attention deficit hyperactivity disorder: 12 weeks prospective study. [2021]
A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. [2021]
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