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

Sponsor

University of Pittsburgh (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05683756

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit and Disruptive Behavior Disorders Attention Deficit Hyperactivity Disorder Child, Preschool Sleep Sleep Disturbance	Behavioral: Brief Parent Behavioral Intervention Behavioral: Sleep-Focused Parent Behavioral Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Intervention Acceptability [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.
Intervention Appropriateness [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.
Intervention Feasibility [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.
Problematic Sleep [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).
ADHD Symptoms [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 Outcome Measures

Nighttime Awakenings [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.
Sleep Latency [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.
Consistency of Bedtime Routine [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.