Telehealth Intervention for Preschool ADHD

(PASS Trial)

Overseen By Matt Gibson

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Stimulants, Psychotropics, Sleep medications

Disqualifiers: Sleep apnea, Autism, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two telehealth programs designed to support caregivers of preschool children with ADHD. The goal is to test methods that improve children's behaviors and routines through positive parenting techniques. Participants will include caregivers of children aged 3-5 with attention issues and notable sleep problems. Those currently using medication for ADHD or sleep issues are not suitable for this study. As an unphased trial, this study offers caregivers a unique opportunity to contribute to innovative strategies that could enhance their child's development and daily life.

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.

What prior data suggests that these telehealth interventions are safe for preschoolers with ADHD?

Research shows that telehealth services can safely and effectively manage ADHD symptoms in children. Studies indicate these services reduce caregiver stress and improve children's behavior. One study examined online programs that teach parents behavior management and found improvements in ADHD symptoms and children's mental health.

In this trial, both groups will focus on teaching parents positive parenting skills to manage their child's behavior. These methods are generally easy to follow and aim to enhance positive interactions.

Overall, the telehealth approach is considered safe and promising for helping kids with ADHD, with no significant reports of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Intervention for preschool ADHD because it offers a fresh approach compared to traditional methods like medication and in-person behavioral therapy. This intervention focuses on evidence-based behavioral parent training delivered through telehealth, making it more accessible for busy families. The training centers on enhancing positive parenting skills, such as establishing routines and using positive attention, which can seamlessly fit into daily life at home and in public settings. By utilizing telehealth, this method potentially reaches more families, providing flexibility and convenience that current options may lack.

What evidence suggests that this trial's telehealth interventions could be effective for preschool ADHD?

Research shows that telehealth services can effectively manage ADHD symptoms in children. In this trial, caregivers will engage in telehealth sessions that focus on evidence-based behavioral parent training. Studies have found that digital mental health programs reduce stress for caregivers and improve children's behavior. Telehealth treatments for ADHD have proven more effective than waiting for treatment, benefiting both adults and children with attention and social skills. These sessions aim to enhance parenting skills and routines, leading to behavioral changes at home and in public. This evidence supports telehealth as a promising method for managing ADHD in preschoolers. ^{1 2 3 6 7}

Who Is on the Research Team?

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.

Exclusion Criteria

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.

My child is currently taking medication for attention, mood, or sleep.

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?

Group I: PASS Arm1 Experimental Treatment 1 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 Arm2 Active Control 1 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

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

The Children's ADHD Telemental Health Treatment Study (CATTS) involved 223 children and showed that a telehealth service model providing pharmacological treatment and caregiver training was significantly more effective than traditional primary care for improving ADHD symptoms and related impairments.

Children receiving telehealth treatment demonstrated greater improvements in attention, hyperactivity, and overall role performance compared to those receiving augmented primary care, highlighting the potential of telehealth to enhance access to effective ADHD care in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a telehealth service delivery model for treating attention-deficit/hyperactivity disorder: a community-based randomized controlled trial. Myers, K., Vander Stoep, A., Zhou, C., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a pilot study involving 21 children with ADHD, blended parent training (online program with therapist support) was not as effective as traditional face-to-face parent training in reducing behavioral problems.

Parents using the blended approach had higher dropout rates and lower satisfaction compared to those in the face-to-face group, and therapists spent significantly less time with parents in the blended condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-directed or therapist-led parent training for children with attention deficit hyperactivity disorder? A randomized controlled non-inferiority pilot trial. Breider, S., de Bildt, A., Nauta, MH., et al.[2022]

The digital therapeutic AKL-T01, designed as a video game-like intervention, significantly improved attentional performance in children with ADHD, showing a mean change in attention scores of 0.93 compared to only 0.03 in the control group, based on a study of 348 participants.

The treatment was well-tolerated with no serious adverse events reported, and only mild side effects such as frustration and headache were noted, indicating that AKL-T01 is a safe alternative to traditional ADHD therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Kollins, SH., DeLoss, DJ., Cañadas, E., et al.[2021]

In a study involving 223 children with ADHD and their caregivers, the hybrid telehealth service delivery model (CATTS) led to significantly greater improvements in caregiver distress compared to a standard care model, as measured by various assessment tools over 25 weeks.

The improvements in caregiver outcomes were linked to reductions in child ADHD symptoms and oppositional defiant disorder (ODD) behaviors, indicating that addressing the child's condition can positively impact caregiver well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Children's Attention-Deficit Hyperactivity Disorder Telemental Health Treatment Study: Caregiver Outcomes. Vander Stoep, A., McCarty, CA., Zhou, C., et al.[2022]

An Internet-delivered intervention for parents of children with ADHD, based on Behavioral Parent Training and Rational Emotive Behavior Therapy, showed high usability and satisfaction among participants, including 24 parents and 16 mental health specialists.

This promising approach suggests that online programs could help increase access to effective ADHD treatments for parents, but further research is needed to evaluate its efficacy in a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ADHDCoach-a virtual clinic for parents of children with ADHD: Development and usability study. Păsărelu, CR., David, D., Dobrean, A., et al.[2023]

In a study of 56 preschool children with ADHD, those receiving a combination of medication and behavioral interventions showed significant improvement in symptoms after 12 weeks, highlighting the efficacy of these treatments.

Clonidine was the most commonly prescribed medication, but it caused sedation in 24% of children, while methylphenidate was well tolerated, indicating the need for careful medication selection based on safety and tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-school attention deficit hyperactivity disorder: 12 weeks prospective study. Vaidyanathan, S., Rajan, TM., Chandrasekaran, V., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of virtual synchronous intervention studies in preschool rehabilitation. Hatherly, K., Glista, D., Testani, D., et al.[2022]

Citations

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Telehealth implementation for children with attention deficit ... The objective of this research was to examine current telehealth practices in managing children with attention deficit hyperactivity disorder (ADHD)

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05862727

Preschool Attention and Sleep Support (PASS) This study will be investigating two telehealth interventions for preschoolers with ADHD. The study is divided into two Aims.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2451958825001186

Efficacy of digital mental health interventions for attention- ... The current meta-analysis investigates the effectiveness of digital mental health interventions for ADHD synthesising data across 23 randomised controlled ...

4. withpower.com withpower.com/trial/phase-psychiatric-health-7-2023-790c6

Telehealth Intervention for Preschool ADHD (PASS Trial) Research shows that telehealth services can effectively manage ADHD symptoms in children, with studies indicating improvements in caregiver stress and child ...

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2022.854810/full

Efficacy of Online Intervention for ADHD: A Meta-Analysis ... These studies showed that online interventions was more effective than waiting list in improving attention deficit and social function of adults and children ...

6. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7340a1.htm

Attention-Deficit/Hyperactivity Disorder Diagnosis, ... Telehealth might have benefits for persons with ADHD, including helping them access behavioral treatment or medication prescriptions for ADHD.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876201825001029

Internet-based behavioural parent training intervention for ... This study evaluates the efficacy of an 8-session internet-based BPT (I-BPT) program in improving ADHD symptoms and mental health outcomes for children and ...