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

Sleep Clinical Trial

— OASIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05683756
• Other study ID #: STUDY22070096
• Secondary ID: R34MH131993
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: September 2026

Study information

• Verified date: December 2023
• Source: University of Pittsburgh
• Contact: Heather M Joseph, DO
• Phone: 4122465338
• Email: liebherrh[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Child, Preschool
• Dyssomnias
• Hyperkinesis
• Mental Disorders
• Parasomnias
• Problem Behavior
• Sleep
• Sleep Disturbance

Intervention

Behavioral:
• Brief Parent Behavioral Intervention
PBI administered in pediatric primary care by an embedded therapist.
• Sleep-Focused Parent Behavioral Intervention
SF-PBI administered in pediatric primary care by an embedded therapist.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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