This study will be investigating two telehealth interventions for preschoolers with ADHD. The study is divided into two Aims. During Aim 1, caregivers of preschoolers with attention concerns, pediatric behavioral health professionals, and pediatric primary care providers will take part in two virtual focus groups to provide their perspective on ways to improve the telehealth intervention being evaluated.
During Aim 2, caregivers of preschool children with ADHD symptoms will be randomly assigned to participate in one of two 9-week telehealth interventions. Both interventions will teach evidence-based skills and provide practice opportunities to manage their children's ADHD-related behaviors. Caregivers and their children will also attend three study visits (one before the intervention, and two following the intervention) where they will be asked to complete questionnaires and assessments related to the child's ADHD symptoms, psychiatric health, and sleep habits. Following each study visit, participating children will be asked to wear an ActiGraph device on their nondominant wrist for 24 hours/day for a 7-day period. During this time, the caregivers will be asked to complete an electronic daily diary about their child's sleep.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
Telehealth intervention that teaches caregivers evidence-based skills and provides practice opportunities to manage their children's ADHD-related behaviors according to their assigned intervention.
Duke University Medical Center
Durham, North Carolina, United States
Change in clinician-rated ADHD-RS
A clinician-rated, 18-item assessment with a 4-point Likert scale ranging from Rarely or never to Very Often. Lower scores indicate better outcomes.
Time frame: Baseline, immediately post-treatment, 3 months post-treatment
Change in caregiver-reported sleep habits as measured by the Short-Form Child Sleep Habits Questionnaire (SF-CSHQ).
A 23-item questionnaire with a 3-point Likert scale ranging from Rarely to Usually. Lower scores indicate better outcomes.
Time frame: Baseline, immediately post-treatment, 3 months post-treatment
Change in Sleep Regularity Index (SRI)
A measure of sleep regularity collected continuously over 7 days via Actigraphy. The SRI is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status
Time frame: Baseline, immediately post-treatment, 3 months post-treatment
Change in psychosocial function as measured by Impairment Rating Scale
A clinician rated, 8-item assessment with a 7-point Likert scale ranging from No problem; definitely does not need treatment/special services to Extreme Problem; definitely needs treatment/special services. Lower scores indicate better outcomes.
Time frame: Baseline, immediately post-treatment, 3 months post-treatment
Change in parenting stress as measured by the Parenting Stress Scale
An 18-item questionnaire with a 5-point Likert Scale ranging from Strongly disagree to Strongly Agree. Lower scores indicate better outcomes.
Time frame: Baseline, immediately post-treatment, 3 months post-treatment
Change in comorbid symptoms as measured by Child Behavioral Checklist for Ages 1½ to 5(CBCL)
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A widely-used 99-item parent report questionnaire with a 3-point Likert Scale ranging from Not True to Very True or Often True. Lower scores indicate better outcomes.
Time frame: Baseline, immediately post-treatment, 3 months post-treatment
Change in sleep midpoint, TST (minutes from sleep start to sleep end), SOL (minutes to first sleep epoch), WASO (minutes awake between sleep start and sleep end), and SE (TST/time in bed).
As measured via actigraphy collected continuously over 7 days.
Time frame: Baseline, immediately post-treatment, 3 months post-treatment
Change in parenting style as measured by the Alabama Parenting Questionnaire
A 33-item questionnaire with a 5-point Likert Scale ranging from Never to Always.
Time frame: Baseline, immediately post-treatment, 3 months post-treatment
Change in severity of behavior problems in the home setting as measured by the Home Situations Questionnaires.
A 16-item questionnaire with a 9-point Likert Scale. Lower scores indicate better outcomes.
Time frame: Baseline, immediately post-treatment, 3 months post-treatment