Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05683756

Optimizing Attention and Sleep Intervention Study

The goal of this pilot clinical effectiveness trial is to compare a brief parent behavioral intervention (PBI) to a modified sleep focused PBI (SF-PBI) delivered by therapists in pediatric primary care for families of children 3-5 years old with sleep problems and early ADHD symptoms.

The main aims are to:

Aim 1: Demonstrate the acceptability, feasibility, and appropriateness of the sleep focused PBI (SF-PBI) delivered in pediatric primary care for preschool-aged children (3-5 years old) at elevated risk for ADHD.

Aim 2: Examine change in target engagement (sleep) and ADHD symptoms among preschool-aged children at elevated risk for ADHD receiving SF-PBI compared to standard PBI.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Attention Deficit and Disruptive Behavior Disorders Attention Deficit Disorder with Hyperactivity Attention Deficit Hyperactivity Disorder Child, Preschool Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Parasomnias Sleep Sleep Disturbance Sleep Wake Disorders

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Community Pediatrics Bass Wolfson, Cranberry, Cranberry Township, Pennsylvania, United States

Loading trial locations.

About this study

Sleep problems may be one mechanism through which young children may be at risk for developing ADHD, although first line ADHD interventions, including parent behavioral interventions (PBIs), do not address sleep. Investigators will test a modified version of a PBI to target sleep disrupting behaviors for children 3-5 years old at elevated risk for ADHD. The intervention will be delivered by behavioral health therapists embedded in pediatric primary care to increase families' access to intervention. This pilot effectiveness trial is the first step towards developing an early intervention targeting sleep as a mechanism to reduce the prevalence, symptoms, and impairments associated with childhood ADHD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Parent/Caregiver:

  • (1) Legal guardian is at least 18 years of age
  • (2) Reads and speaks English

Child:

  • (1) 3-5 years of age
  • (2) Caregiver report of 4 or more ADHD symptoms
  • (3) Caregiver reports child's sleep as a "moderate" or "serious problem"
  • (4) English speaking
  • (5) Child receives care from participating pediatric primary care office

Exclusion criteria

  • (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea)
  • (2) Severe neurodevelopmental disorder

Treatment and study plan

Brief Parent Behavioral Intervention

Behavioral

PBI administered in pediatric primary care by an embedded therapist.

Sleep-Focused Parent Behavioral Intervention

Behavioral

SF-PBI administered in pediatric primary care by an embedded therapist.

Primary outcomes

  1. Intervention Acceptability

    Time frame: Post Intervention at approximately 4 months

    Therapists and caregiver report of intervention acceptability will be assessed using the 4-item Acceptability of Intervention Measure (AIM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good acceptability.

  2. Intervention Appropriateness

    Time frame: Post Intervention at approximately 4 months

    Therapists and caregiver report of intervention appropriateness will be assessed using the 4-item Intervention Appropriateness Measure (IAM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good appropriateness.

  3. Intervention Feasibility

    Time frame: Post Intervention at approximately 4 months

    Therapists and caregiver report of intervention feasibility will be assessed using the 4-item Feasibility of Intervention Measure (FIM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good feasibility.

  4. Problematic Sleep

    Time frame: Change from baseline up to 8 months

    Using the Brief Child Sleep Questionnaire caregivers will report on their perception of child's sleep as problematic, rated 1 (Not at all) to 5 (A serious problem).

  5. ADHD Symptoms

    Time frame: Change from baseline up to 8 months

    Using the 18-item ADHD Rating Scale-IV-Preschool Version caregivers will report on the child's ADHD symptoms. Symptoms are rated from 0 (Rarely) to 3 (Very Often).

Secondary outcomes

  1. Nighttime Awakenings

    Time frame: Change from baseline up to 8 months

    Caregivers will report how many times their child typically wakes during the night, using the Brief Child Sleep Questionnaire.

  2. Sleep Latency

    Time frame: Change from baseline up to 8 months

    Sleep latency will be determined by using the caregiver report of how long it typically takes their child to fall asleep (number of minutes), using the Brief Child Sleep Questionnaire.

  3. Consistency of Bedtime Routine

    Time frame: Change from baseline up to 8 months

    Caregivers will report the number of days, in a typical week, they regularly put their child to bed at the same time (within 15 minutes), using the Brief Child Sleep Questionnaire.

Other outcomes

  1. Actigraphy

    Time frame: Change from baseline up to 8 months

    Actigraphy is collected for 10 days at each of the three study timepoints. These data are to assess feasibility of actigraphy data collection with this population and will be used in exploratory analyses.

  2. Sleep Diary

    Time frame: Change from baseline up to 8 months

    Sleep diary is collected for 10 days at each of the three study timepoints. These data are to assess feasibility of parent reported sleep diary data collection with this population and will be used in exploratory analyses.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Optimizing Attention and Sleep Intervention Study: A Pilot RCT to Compare Parent Behavioral Interventions With and Without Sleep Strategies Delivered in Pediatric Primary Care for Preschool-aged Children at Risk of Childhood ADHD

Acronym: OASIS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2023
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.