Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Hyperactivity Disorder, Child, Preschool, Sleep, Sleep Disturbance
Conditions
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: 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.
Interventions
BEHAVIORALBrief Parent Behavioral Intervention
PBI administered in pediatric primary care by an embedded therapist.
BEHAVIORALSleep-Focused Parent Behavioral Intervention
SF-PBI administered in pediatric primary care by an embedded therapist.
Sponsors
University of Pittsburgh
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
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 * (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
Exclusion criteria
* (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea) * (2) Severe neurodevelopmental disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHeather M Joseph, DO
Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh
Outcome results
None listed