Preschool Attention and Sleep Support (PASS)

ADHD Clinical Trial

— PASS  

Official title:

Preschool Attention and Sleep Support (PASS): A Telehealth Intervention for Children at Risk for ADHD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862727
• Other study ID #: Pro00111845
• Secondary ID: R34MH131994-01
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: May 10, 2025

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: Matt Gibson
• Phone: 919-681-2521
• Email: matthew.gibson646[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

During Aim 2, caregivers of preschool children with ADHD symptoms will be randomly assigned to participate in one of two 8-week telehealth interventions. Both interventions will teach evidence-based skills and provide practice opportunities to manage their children's ADHD-related behaviors. Caregivers and their children will also attend three study visits (one before the intervention, and two following the intervention) where they will be asked to complete questionnaires and assessments related to the child's ADHD symptoms, psychiatric health, and sleep habits. Following each study visit, participating children will be asked to wear an ActiGraph device on their nondominant wrist for 24 hours/day for a 7-day period. During this time, the caregivers will be asked to complete an electronic daily diary about their child's sleep.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 10, 2025
• Est. primary completion date: May 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

Inclusion Criteria:

• child must be ages 3-5 years at intake

• child with score of 30 on the Child Sleep Habits Survey-Short Form and a caregiver rating of child's sleep problems as moderate/severe

• child with =80th percentile on the clinician-rated ADHD-RS based on age and sex norms, with at least 4 symptoms in the clinically significant range (scores of 2-3) in either the inattention or hyperactive/impulsive domains

• parent/caregiver must have ability to speak, read, and write in English

• parent/caregiver must have access to a device with internet and/or smartphone to access telehealth visits

• parent/caregiver must have ability to follow written and verbal instructions

• parent/caregiver must have ability and willingness to comply with study procedures.

Exclusion Criteria:

• child with suspected obstructive sleep apnea or restless legs syndrome (via screening questionnaires)

• child with current use of stimulant medication, other psychotropics, or medications for sleep (prescription or over-the-counter, including melatonin)

• child with caregiver report of psychiatric disorder other than ADHD requiring treatment (medication and/or therapy), Autism Spectrum Disorder, or intellectual disability

• parent/caregiver is currently participating in another parent training intervention and have previously participated in another parent training intervention in the past 6 months.

• Severe and/or uncontrolled medical condition (e.g., pulmonary and neurological conditions such as cystic fibrosis and seizure disorder) that would interfere with sleep and/or study participation according to the study team

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• Telehealth Intervention
Telehealth intervention that teaches caregivers evidence-based skills and provides practice opportunities to manage their children's ADHD-related behaviors according to their assigned intervention.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Fidelity	The percentage of content and practices of the PASS protocol that were delivered (yes/no) across providers as determined by rater's assessment of recorded sessions.	During the 8-week treatment
Other	Feasibility of Recruitment	The percentage of enrolled participants who attend a screening visit.	Baseline
Other	Feasibility of Randomization	The percent of randomized participants who meet study eligibility after attending the screening visit.	Baseline
Other	Integrity of the control condition as measured by the PASS Fidelity Checklist.	The incidence of administration of core PASS elements in each session of the control group determined by rater.	During the 8-week treatment
Other	Integrity of the control condition as measured by the Integrity of the Blind questionnaire.	Asking all blinded informant (parents, assessors) to guess whether the child was in the control or experimental group and to state their confidence in this guess on a 1 to 10 scale. Higher scores indicate higher confidence in guess.	immediately post-treatment
Other	Index of treatment engagement as measured by attendance.	Average number PASS groups sessions attended by participants.	During the 8-week treatment
Other	Adherence to between-session practice.	Assessed via a therapist-completed item assessing the degree to which the caregiver was adherent overall with homework immediately after each session on a scale of 1 (not at all) to 5 (extremely strong).	During the 8-week treatment
Other	Retention	Measured by the number of families who complete post-treatment and follow-up assessments.	Immediately post-treatment, 3 months post-treatment
Other	Acceptability as measured by the Satisfaction with Therapy and Therapist Scale (STTS-R).	A 13-item questionnaire with a 5-point Likert Scale ranging from Strongly Disagree (1) to Strongly Agree (5). Higher scores indicate better outcomes.	Immediately post-treatment
Primary	Change in clinician-rated ADHD-RS	A clinician-rated, 18-item assessment with a 4-point Likert scale ranging from Rarely or never to Very Often.; Lower scores indicate better outcomes.	Baseline, immediately post-treatment, 3 months post-treatment
Primary	Change in caregiver-reported sleep habits as measured by the Short-Form Child Sleep Habits Questionnaire (SF-CSHQ).	A 23-item questionnaire with a 3-point Likert scale ranging from Rarely to Usually. Lower scores indicate better outcomes.	Baseline, immediately post-treatment, 3 months post-treatment
Primary	Change in Sleep Regularity Index (SRI)	A measure of sleep regularity collected continuously over 7 days via Actigraphy. The SRI is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status	Baseline, immediately post-treatment, 3 months post-treatment
Secondary	Change in psychosocial function as measured by Impairment Rating Scale	A clinician rated, 8-item assessment with a 7-point Likert scale ranging from No problem; definitely does not need treatment/special services to Extreme Problem; definitely needs treatment/special services. Lower scores indicate better outcomes.	Baseline, immediately post-treatment, 3 months post-treatment
Secondary	Change in parenting stress as measured by the Parenting Stress Scale	An 18-item questionnaire with a 5-point Likert Scale ranging from Strongly disagree to Strongly Agree. Lower scores indicate better outcomes.	Baseline, immediately post-treatment, 3 months post-treatment
Secondary	Change in comorbid symptoms as measured by Child Behavioral Checklist for Ages 1½ to 5(CBCL)	A widely-used 99-item parent report questionnaire with a 3-point Likert Scale ranging from Not True to Very True or Often True. Lower scores indicate better outcomes.	Baseline, immediately post-treatment, 3 months post-treatment
Secondary	Change in sleep midpoint, TST (minutes from sleep start to sleep end), SOL (minutes to first sleep epoch), WASO (minutes awake between sleep start and sleep end), and SE (TST/time in bed).	As measured via actigraphy collected continuously over 7 days.	Baseline, immediately post-treatment, 3 months post-treatment
Secondary	Change in parenting style as measured by the Alabama Parenting Questionnaire	A 33-item questionnaire with a 5-point Likert Scale ranging from Never to Always.	Baseline, immediately post-treatment, 3 months post-treatment
Secondary	Change in severity of behavior problems in the home setting as measured by the Home Situations Questionnaires.	A 16-item questionnaire with a 9-point Likert Scale. Lower scores indicate better outcomes.	Baseline, immediately post-treatment, 3 months post-treatment