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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH131994-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PASS Arm1 | Experimental | 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. |
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| PASS Arm2 | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | Baseline, immediately post-treatment, 3 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, immediately post-treatment, 3 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the 9-week treatment |
| Feasibility of Recruitment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Lunsford-Avery, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41728023 | Derived | Davis NO, Eichner B, Gibson MJ, Lunsford-Avery JR. Preschool attention and sleep support (PASS): protocol for a pilot feasibility randomized clinical trial. Front Sleep. 2026 Feb 6;4:1662221. doi: 10.3389/frsle.2025.1662221. eCollection 2025. |
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All of the individual participant data collected during the trial (including data dictionaries) will be available for this study after deidentification.
Immediately following publication. No end date.
Data will be accessible by researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals and questions for data access should be directed to NDAHelp@mail.nih.gov. To gain access, data requestors will need to sign a data access agreement at https://nda.nih.gov/nda/access-data-info.html.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 4, 2024 | Sep 16, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Behavioral Telehealth Intervention
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Participants will be randomly assigned to one of two interventions, and will not be told which intervention they are assigned to. Outcomes assessor will also be blinded to intervention assignment.
| 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. | 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. | 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. | 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. | 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. | Baseline, immediately post-treatment, 3 months post-treatment |
The percentage of enrolled participants who attend a screening visit.
| Baseline |
| Feasibility of Randomization | The percent of randomized participants who meet study eligibility after attending the screening visit. | 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. | 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. | immediately post-treatment |
| Index of treatment engagement as measured by attendance. | Average number PASS groups sessions attended by participants. | 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). | During the 9-week treatment |
| Retention | Measured by the number of families who complete post-treatment and follow-up assessments. | 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. | 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. | 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. | Baseline, immediately post-treatment, 3 months post-treatment |