An interventional study of Telehealth Intervention in ADHD and Psychiatric Health, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 3 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 46 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Caregivers will receive sessions of evidence-based behavioral parent training which focuses on improving behaviors, such as establishing daytime and bedtime routines, through enhancement of positive parenting skills, including modifying antecedents, applying/withdrawing positive attention as a consequence, and shaping behavior using salient rewards.
Behavioral: Telehealth Intervention
Caregivers will receive sessions of evidence-based behavioral parent training which focuses on improving behaviors, including in home and public settings, through enhancement of positive parenting skills, including modifying antecedents, applying/withdrawing positive attention as a consequence, and shaping behavior using salient rewards.
Behavioral: Telehealth Intervention
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.
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)
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
Treatment Fidelity
The percentage of content and practices of the PASS protocol that were delivered (yes/no) across providers as determined by rater's assessment of recorded sessions.
Time frame: During the 9-week treatment
Feasibility of Recruitment
The percentage of enrolled participants who attend a screening visit.
Time frame: Baseline
Feasibility of Randomization
The percent of randomized participants who meet study eligibility after attending the screening visit.
Time frame: Baseline
Integrity of the control condition as measured by the PASS Fidelity Checklist.
The incidence of administration of core PASS elements in each session of the control group determined by rater.
Time frame: During the 9-week treatment
Integrity of the control condition as measured by the Integrity of the Blind questionnaire.
Asking all blinded informant (parents, assessors) to guess whether the child was in the control or experimental group and to state their confidence in this guess on a 1 to 10 scale. Higher scores indicate higher confidence in guess.
Time frame: immediately post-treatment
Index of treatment engagement as measured by attendance.
Average number PASS groups sessions attended by participants.
Time frame: During the 9-week treatment
Adherence to between-session practice.
Assessed via a therapist-completed item assessing the degree to which the caregiver was adherent overall with homework immediately after each session on a scale of 1 (not at all) to 5 (extremely strong).
Time frame: During the 9-week treatment
Retention
Measured by the number of families who complete post-treatment and follow-up assessments.
Time frame: Immediately post-treatment, 3 months post-treatment
Acceptability as measured by the Satisfaction with Therapy and Therapist Scale (STTS-R).
A 13-item questionnaire with a 5-point Likert Scale ranging from Strongly Disagree (1) to Strongly Agree (5). Higher scores indicate better outcomes.
Time frame: Immediately post-treatment
The Client Credibility Questionnaire
4 item questionnaire to determine how logical and successful the treatment is; if they would recommend the intervention to others; and how much symptoms improved.
Time frame: Immediately post-treatment
Parenting Sense of Competence Scale
A 17-item questionnaire with a 6-point Likert Scale ranging from Strongly Disagree (1) to Strongly Agree (6). A higher score indicates a higher parenting sense of competency.
Time frame: Baseline, immediately post-treatment, 3 months post-treatment
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All of the individual participant data collected during the trial (including data dictionaries) will be available for this study after deidentification.
Supporting information: Study protocol
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
Duke University