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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
PBI administered in pediatric primary care by an embedded therapist.
SF-PBI administered in pediatric primary care by an embedded therapist.
Children's Community Pediatrics Bass Wolfson, Cranberry
Cranberry Township, Pennsylvania, United States
RECRUITINGChildren's Community Pediatrics GIL Murrysville
Monroeville, Pennsylvania, United States
RECRUITINGChildren's Community Pediatrics Shenango
New Castle, Pennsylvania, United States
RECRUITINGChildren's Community Pediatrics Neshannock
New Castle, Pennsylvania, United States
NOT_YET_RECRUITINGChildren's Community Pediatrics GIL East Liberty
Pittsburgh, Pennsylvania, United States
RECRUITINGUniversity of Pittsburgh
Pittsburgh, Pennsylvania, United States
RECRUITINGChildren's Community Pediatrics Bass Wolfson, Squirrel Hill
Pittsburgh, Pennsylvania, United States
RECRUITINGIntervention 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Change from baseline up to 8 months
Nighttime Awakenings
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
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.
Time frame: 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.
Time frame: Change from baseline up to 8 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.