A Sleep Focused Parenting Intervention for Preschool Aged Children at Risk for ADHD (OASIS)

A Parent Behavioral Intervention Targeting Sleep Among Preschool Aged Children at Elevated Risk for Attention-Deficit/Hyperactivity Disorder (ADHD): A Pilot Effectiveness Trial in Pediatric Primary Care

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:

• Demonstrate acceptability, feasibility, and appropriateness of the SF-PBI.
• Examine change in sleep and ADHD symptoms among preschoolers with ADHD symptoms receiving SF-PBI compared to the brief PBI.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Sleep Disturbance; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Hyperactivity Disorder; Child, Preschool
• Intervention / Treatment: Behavioral: Brief Parent Behavioral Intervention; Behavioral: Sleep-Focused Parent Behavioral Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather M Joseph, DO; Phone Number: 4122465338; Email: liebherrh@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Parent/Caregiver:

• (1) Legal guardian is at least 18 years of age
• (2) English speaking

Child:

• (1) 3-5 years of age
• (2) Caregiver report of 4 or more ADHD symptoms
• (3) Caregiver report of one or more sleep problems
• (4) English speaking.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Brief Parent Behavioral Intervention; A brief parent behavioral intervention with evidenced based strategies for treatment of ADHD.	Behavioral: Brief Parent Behavioral Intervention; PBI administered in pediatric primary care by an embedded therapist.
Experimental: Sleep-Focused Parent Behavioral Intervention; A modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors.	Behavioral: Sleep-Focused Parent Behavioral Intervention; SF-PBI administered in pediatric primary care by an embedded therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability	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.	Post Intervention at approximately 4 months
Intervention Appropriateness	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.	Post Intervention at approximately 4 months
Intervention Feasibility	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.	Post Intervention at approximately 4 months
Problematic Sleep	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).	Change from baseline up to 8 months
ADHD Symptoms	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).	Change from baseline up to 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nighttime Awakenings	Caregivers will report how many times their child typically wakes during the night, using the Brief Child Sleep Questionnaire.	Change from baseline up to 8 months
Sleep Latency	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.	Change from baseline up to 8 months
Consistency of Bedtime Routine	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.	Change from baseline up to 8 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Heather M Joseph, DO, Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh

Publications and helpful links

General Publications

• Cunningham CE, Bremner R, Boyle M. Large group community-based parenting programs for families of preschoolers at risk for disruptive behaviour disorders: utilization, cost effectiveness, and outcome. J Child Psychol Psychiatry. 1995 Oct;36(7):1141-59. doi: 10.1111/j.1469-7610.1995.tb01362.x.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Nervous System Diseases; Sleep Wake Disorders; Neurologic Manifestations; Dyskinesias; Neurodevelopmental Disorders; Problem Behavior; Mental Disorders; Dyssomnias; Parasomnias; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Attention Deficit and Disruptive Behavior Disorders
• Other Study ID Numbers: STUDY22070096; R34MH131993 (U.S. NIH Grant/Contract: National Institute of Mental Health (NIMH))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data collected during the trial will be shared, after deidentification, via the NIMH National Data Archive.
• IPD Sharing Time Frame: Data will be shared upon publication or 1 year after the grant end date. Data will be available indefinitely.
• IPD Sharing Access Criteria: Any NIMH NDA authorized users may request the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No