Clinical trial NCT05862727: Preschool Attention and Sleep Support (PASS)
Official title: Preschool Attention and Sleep Support (PASS): A Telehealth Intervention for Children at Risk for ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Psychiatric Health
Keywords: Psychiatric Health
Children
Preschool
ADHD
Telehealth Intervention
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-05-17
Enrollment: 44
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral Telehealth Intervention
Primary purpose: TREATMENT

Brief 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.

Detailed description: During Aim 2, caregivers of preschool children with ADHD symptoms will be randomly assigned to participate in one of two 9-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.

Eligibility criteria: 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 or 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

Primary outcomes:
measure: Change in clinician-rated ADHD-RS
timeFrame: Baseline, immediately post-treatment, 3 months post-treatment
measure: Change in caregiver-reported sleep habits as measured by the Short-Form Child Sleep Habits Questionnaire (SF-CSHQ).
timeFrame: Baseline, immediately post-treatment, 3 months post-treatment
measure: Change in Sleep Regularity Index (SRI)
timeFrame: Baseline, immediately post-treatment, 3 months post-treatment
Secondary outcomes:
measure: Change in psychosocial function as measured by Impairment Rating Scale
timeFrame: Baseline, immediately post-treatment, 3 months post-treatment
measure: Change in parenting stress as measured by the Parenting Stress Scale
timeFrame: Baseline, immediately post-treatment, 3 months post-treatment
measure: Change in comorbid symptoms as measured by Child Behavioral Checklist for Ages 1½ to 5(CBCL)
timeFrame: Baseline, immediately post-treatment, 3 months post-treatment
measure: 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).
timeFrame: Baseline, immediately post-treatment, 3 months post-treatment
measure: Change in parenting style as measured by the Alabama Parenting Questionnaire
timeFrame: Baseline, immediately post-treatment, 3 months post-treatment
measure: Change in severity of behavior problems in the home setting as measured by the Home Situations Questionnaires.
timeFrame: Baseline, immediately post-treatment, 3 months post-treatment
Other outcomes:
measure: Treatment Fidelity
timeFrame: During the 9-week treatment
measure: Feasibility of Recruitment
timeFrame: Baseline
measure: Feasibility of Randomization
timeFrame: Baseline
measure: Integrity of the control condition as measured by the PASS Fidelity Checklist.
timeFrame: During the 9-week treatment
measure: Integrity of the control condition as measured by the Integrity of the Blind questionnaire.
timeFrame: immediately post-treatment
measure: Index of treatment engagement as measured by attendance.
timeFrame: During the 9-week treatment
measure: Adherence to between-session practice.
timeFrame: During the 9-week treatment
measure: Retention
timeFrame: Immediately post-treatment, 3 months post-treatment
measure: Acceptability as measured by the Satisfaction with Therapy and Therapist Scale (STTS-R).
timeFrame: Immediately post-treatment
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jessica Lunsford-Avery, PhD
role: PRINCIPAL_INVESTIGATOR
References: