Attention Deficit and Disruptive Behavior DisordersOASISNCT05683756
Optimizing Attention and Sleep Intervention Study
A study testing Brief Parent Behavioral Intervention and Sleep-Focused Parent Behavioral Intervention in people with Attention Deficit and Disruptive Behavior Disorders and Attention Deficit Hyperactivity Disorder, run by University of Pittsburgh at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Hyperactivity Disorder, Child, Preschool
- What is being tested?
- Brief Parent Behavioral Intervention and Sleep-Focused Parent Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Dec 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- (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
Who cannot join
- (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea)
- (2) Severe neurodevelopmental disorder
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Children's Community Pediatrics Bass Wolfson, Cranberry
Cranberry Township, Pennsylvania, 16066
Children's Community Pediatrics GIL Murrysville
Monroeville, Pennsylvania, 15146
Children's Community Pediatrics Shenango
New Castle, Pennsylvania, 16101
Children's Community Pediatrics Neshannock
New Castle, Pennsylvania, 16105
Children's Community Pediatrics GIL East Liberty
Pittsburgh, Pennsylvania, 15206
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Children's Community Pediatrics Bass Wolfson, Squirrel Hill
Pittsburgh, Pennsylvania, 15217
About this study
Official 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
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.
Read the 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.
- Conditions
- Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Hyperactivity Disorder, Child, Preschool, Sleep, Sleep Disturbance
- Being tested
- Brief Parent Behavioral Intervention, Sleep-Focused Parent Behavioral Intervention
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder with Hyperactivity, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Parent Behavioral InterventionBehavioural
PBI administered in pediatric primary care by an embedded therapist.
Sleep-Focused Parent Behavioral InterventionBehavioural
SF-PBI administered in pediatric primary care by an embedded therapist.
| Study group | Role | What they receive |
|---|---|---|
| Brief Parent Behavioral Intervention | Active comparator | A brief parent behavioral intervention with evidenced based strategies for treatment of ADHD. Receives: Behavioral: Brief Parent Behavioral Intervention |
| Sleep-Focused Parent Behavioral Intervention | Experimental | A modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors. Receives: Behavioral: Sleep-Focused Parent Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Change from baseline up to 8 months
Secondary outcomes (3)
Nighttime Awakenings
Caregivers will report how many times their child typically wakes during the night, using the Brief Child Sleep Questionnaire.
Measured: 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.
Measured: 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.
Measured: Change from baseline up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit and Disruptive Behavior DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Heather Joseph, University of Pittsburgh
- Investigators
- Heather M Joseph, DO, Principal investigator, Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683756
- Sponsor's protocol ID
- STUDY22070096
- Other IDs
- R34MH131993
- Acronym
- OASIS
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data collected during the trial will be shared, after deidentification, via the NIMH National Data Archive.
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.
PubMed 8847377Joseph HM, Levenson JC, Conlon RPK, Mannion K, Kipp HL, Gradian A, Wallace ML, Williamson AA. Optimizing Attention and Sleep Intervention Study (OASIS): a protocol for a pilot randomized controlled trial to compare parent behavioral interventions with and without sleep strategies delivered in pediatric primary care for preschool-aged children at risk of childhood ADHD. Pilot Feasibility Stud. 2025 Feb 25;11(1):22. doi: 10.1186/s40814-025-01600-0.
PubMed 40001155
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05683756
- Acronym / sponsor ID
- OASIS / STUDY22070096
- Conditions
- Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Hyperactivity Disorder, Child, Preschool, Sleep, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Parent Behavioral Intervention | Active comparator | Behavioral: Brief Parent Behavioral InterventionA brief parent behavioral intervention with evidenced based strategies for treatment of ADHD. |
| Sleep-Focused Parent Behavioral Intervention | Experimental | Behavioral: Sleep-Focused Parent Behavioral InterventionA modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- (1) Legal guardian is at least 18 years of age
- (2) Reads and speaks English
- (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"
Key exclusion criteria (2 listed)
- (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea)
- (2) Severe neurodevelopmental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Parent Behavioral InterventionPBI administered in pediatric primary care by an embedded therapist. | Behavioural | Brief Parent Behavioral Intervention |
| Sleep-Focused Parent Behavioral InterventionSF-PBI administered in pediatric primary care by an embedded therapist. | Behavioural | Sleep-Focused Parent Behavioral Intervention |
Primary outcome
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.
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.
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.
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).
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).
3 secondary outcomes
Nighttime Awakenings
Time frame: Change from baseline up to 8 months
Sleep Latency
Time frame: Change from baseline up to 8 months
Consistency of Bedtime Routine
Time frame: Change from baseline up to 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 8847377Cunningham 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 publication: PubMed 40001155Joseph HM, Levenson JC, Conlon RPK, Mannion K, Kipp HL, Gradian A, Wallace ML, Williamson AA. Optimizing Attention and Sleep Intervention Study (OASIS): a protocol for a pilot randomized controlled trial to compare parent behavioral interventions with and without sleep strategies delivered in pediatric primary care for preschool-aged children at risk of childhood ADHD. Pilot Feasibility Stud. 2025 Feb 25;11(1):22. doi: 10.1186/s40814-025-01600-0.
- Individual participant dataSharing planned: Yes. Individual participant data collected during the trial will be shared, after deidentification, via the NIMH National Data Archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather M Joseph, DO principal investigator
Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Parent Behavioral Intervention and Sleep-Focused Parent Behavioral Intervention in people with Attention Deficit and Disruptive Behavior Disorders and Attention Deficit Hyperactivity Disorder, run by University of Pittsburgh at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Acceptability (time frame: Post Intervention at approximately 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05683756, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.