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

Primary Purpose

Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Hyperactivity Disorder, Child, Preschool

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Parent Behavioral Intervention
Sleep-Focused Parent Behavioral Intervention
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit and Disruptive Behavior Disorders

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Brief Parent Behavioral Intervention

Sleep-Focused Parent Behavioral Intervention

Arm Description

A brief parent behavioral intervention with evidenced based strategies for treatment of ADHD.

A modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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).

Secondary Outcome Measures

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

Full Information

First Posted
November 24, 2022
Last Updated
October 16, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05683756
Brief Title
A Sleep Focused Parenting Intervention for Preschool Aged Children at Risk for ADHD
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Hyperactivity Disorder, Child, Preschool, Sleep, Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief Parent Behavioral Intervention
Arm Type
Active Comparator
Arm Description
A brief parent behavioral intervention with evidenced based strategies for treatment of ADHD.
Arm Title
Sleep-Focused Parent Behavioral Intervention
Arm Type
Experimental
Arm Description
A modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Brief Parent Behavioral Intervention
Intervention Description
PBI administered in pediatric primary care by an embedded therapist.
Intervention Type
Behavioral
Intervention Name(s)
Sleep-Focused Parent Behavioral Intervention
Intervention Description
SF-PBI administered in pediatric primary care by an embedded therapist.
Primary Outcome Measure Information:
Title
Intervention Acceptability
Description
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.
Time Frame
Post Intervention at approximately 4 months
Title
Intervention Appropriateness
Description
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.
Time Frame
Post Intervention at approximately 4 months
Title
Intervention Feasibility
Description
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.
Time Frame
Post Intervention at approximately 4 months
Title
Problematic Sleep
Description
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).
Time Frame
Change from baseline up to 8 months
Title
ADHD Symptoms
Description
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).
Time Frame
Change from baseline up to 8 months
Secondary Outcome Measure Information:
Title
Nighttime Awakenings
Description
Caregivers will report how many times their child typically wakes during the night, using the Brief Child Sleep Questionnaire.
Time Frame
Change from baseline up to 8 months
Title
Sleep Latency
Description
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.
Time Frame
Change from baseline up to 8 months
Title
Consistency of Bedtime Routine
Description
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.
Time Frame
Change from baseline up to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather M Joseph, DO
Phone
4122465338
Email
liebherrh@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather M Joseph, DO
Organizational Affiliation
Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://nda.nih.gov
Citations:
PubMed Identifier
8847377
Citation
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.
Results Reference
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A Sleep Focused Parenting Intervention for Preschool Aged Children at Risk for ADHD

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