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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH127139-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The investigators propose to conduct a pilot randomized controlled feasibility trial to evaluate the feasibility and effectiveness of a pre-visit intervention to improve communication about attention deficit hyperactivity disorder. The investigators will enroll 140 English-speaking youth ages 11-17 with an ADHD medical record diagnosis who screen as having predominantly inattentive subtype, hyperactive/impulsive subtype, or combined inattention/hyperactivity on the Vanderbilt parent assessment scale from three pediatric clinics. The investigators will randomize the families to receive both the question prompt lists and video (N=35), just the question prompt lists (N=35), just the video (N=35), or usual care (N=35). This will allow the team to understand whether both the video and question prompt list components are needed for the larger trial. The aims of the investigators are:
Aim 1: To examine whether the ADHD question prompt lists and/or pre-visit video significantly impact the proposed mechanisms of the intervention. The team will investigate whether adolescents and parents in each of the intervention groups: (a) ask more questions and receive more provider education about ADHD during their baseline and 3-month visits and (b) have higher self-efficacy at 3 and 6 months than adolescents and parents in the usual care group.
Aim 2: To investigate the effectiveness of the ADHD question prompt lists and/or the pre-visit video by examining whether adolescents in each of the intervention groups have improved ADHD symptoms, school and social performance, and quality-of-life at 6 months compared to those in the usual care group.
Aim 3: To assess adolescent and parent feedback on the acceptability, feasibility, tolerability, and safety of using the ADHD question prompt lists and/or the pre-visit video. The results from this pilot trial will be used to inform a larger trial by: (a) identifying the intervention arm with the greatest potential impact, acceptability, feasibility, and tolerability, and (b) determine the best mechanisms and outcome variables to assess in a larger trial.
Using Social Cognitive Theory as a guide, the investigators hypothesize that an ADHD video/question prompt list intervention will increase youth and parent question-asking which, in turn, will increase provider education during the medical visit, which ultimately will improve youth and parent ADHD self-efficacy. Youth and parent question asking, provider education, and self-efficacy are the proposed mechanisms of the intervention. By improving youth and parent self-efficacy to manage ADHD, the investigators also hypothesize that youth ADHD symptoms, school and social performance, and quality-of-life will improve.
The investigators propose to conduct a pilot randomized controlled feasibility trial to evaluate the feasibility and effectiveness of a pre-visit intervention to improve communication about ADHD. The team will enroll 140 English-speaking youth ages 11-17 with an ADHD medical record diagnosis who screen as having predominantly inattentive subtype, hyperactive/impulsive subtype, or combined inattention/hyperactivity on the Vanderbilt parent assessment scale from three pediatric clinics. The investigators will randomize the families to receive both the question prompt lists and video (N=35), just the question prompt lists (N=35), just the video (N=35), or usual care (N=35). This will allow us to understand whether both the video and question prompt list components are needed for the larger trial. The aims of the investigators are:
Aim 1: To examine whether the ADHD question prompt lists and/or pre-visit video significantly impact the proposed mechanisms of the intervention. The team will investigate whether adolescents and parents in each of the intervention groups: (a) ask more questions and receive more provider education about ADHD during their baseline and 3 month visits and (b) have higher self-efficacy at 3 and 6 months than adolescents and parents in the usual care group.
Aim 2: To investigate the effectiveness of the ADHD question prompt lists and/or the pre-visit video by examining whether adolescents in each of the intervention groups have improved ADHD symptoms, school and social performance, and quality-of-life at 6 months compared to those in the usual care group.
Aim 3: To assess adolescent and parent feedback on the acceptability, feasibility, tolerability, and safety of using the ADHD question prompt lists and/or the pre-visit video. The results from this pilot trial will be used to inform a larger trial by: (a) identifying the intervention arm with the greatest potential impact, acceptability, feasibility, and tolerability, and (b) determine the best mechanisms and outcome variables to assess in a larger trial.
The investigators will conduct this study at three pediatric clinics. The principal investigator will enroll 30 providers from three participating pediatric clinics. Those providers who are interested will complete a consent form and a short demographic questionnaire. Eligible patients of participating providers will be called by clinic staff who will explain the study. The clinic staff will ask interested families to arrive 20 minutes before their next visit to meet with a research assistant to learn more about the study. The investigators will enroll 140 youth (approximately 40 to 60 from each clinic). The UNC research staff will explain the study. The research assistant will take the family to a private area within the clinic to learn more about the study. The research assistant will obtain parent informed consent, parent permission, and youth assent. Parents will be asked to complete HIPAA forms. Then the research assistant will administer the eligibility screener. Youth will be randomized to either the question prompt list only group (N=35), the pre-visit video only group (N=35), the combined question prompt list/video intervention group (N=35), or the control group (N=35), stratified by provider. This will ensure group balance. Using a random number generator, the biostatistician will prepare opaque, sealed envelopes containing group assignments. The research assistant will open the envelope when a youth enrolls into the study. Youth and parents in question prompt list group will be handed the prompt lists and will be told, "Your provider wants you to ask any questions that you have about ADHD. Here are lists of questions that you may want to ask. Please spend some time reading through this and marking any questions you want to ask your provider during the visit. You can also write other questions you want to ask on the bottom." Parents and youth in the pre-visit video only group will watch a short educational video with six themes on an iPad encouraging families to ask questions and to be engaged during ADHD visits. Youth and parents in the combined pre-visit video/question prompt list group will watch the video and will then be handed the question prompt lists and given the instructions above. The control group will receive usual care.
Next, all participating families (both the intervention and control group families) will have their medical visits audio-tape recorded. After the medical visit, the research assistant will conduct a 15- to 20-minute interview with all participating youth while parents complete a questionnaire. For those in the question prompt list or combined video/question prompt list intervention groups, the research assistant will collect the youth's and parent's question prompt lists so that the investigators can compare what questions the youth and parent wanted to ask to what the youth and parent asked during the visit.
Youth typically come back for ADHD follow-up visits every 3 months. Families in the intervention groups will receive the intervention to which the families were randomly assigned to use at each follow-up visit. The research assistant will interview all youth and have the parent complete a questionnaire after the 3- and 6-month visits. The research assistant will audiotape the 3 month visit since the investigators will be examining how baseline and 3-month communication is associated with 6-month outcomes. The youth's medical records will be reviewed for ADHD diagnosis date, co-morbidities, number of ADHD visits, and ADHD treatment use (medications and other strategies) for the 6-month period before enrollment into the study and the 6-month period after.
Youth will receive a small stipend for each interview and parents will receive a small stipend as well for completing the questionnaire at each time point (baseline, 3 months, and 6 months).
The adolescents in the intervention groups will complete the acceptability, feasibility, and tolerability questions at the 6-month interviews and the parents will complete them in the 6-month questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Question prompt list only group | Experimental | In the question prompt list group youth will be handed the youth ADHD prompt list, and the parent will be handed the parent ADHD prompt list, and will be told, "Your provider wants you to ask any questions that you have about ADHD. Here are lists of questions that you may want to ask. Please spend some time reading through this and marking any questions you want to ask your provider during the visit. You can also write other questions you want to ask on the bottom." |
|
| Video only group | Experimental | Parents and youth in the pre-visit video only group will watch together a short educational video with six themes on an iPad encouraging families to ask questions and to be engaged during ADHD visits. |
|
| Combined question prompt list/video intervention group | Experimental | In the combined pre-visit video/question prompt list group youth will watch the video with the parent. Then, youth will be handed the youth ADHD prompt list, and the parent will be handed the parent ADHD prompt list, and will be told, "Your provider wants you to ask any questions that you have about ADHD. Here are lists of questions that you may want to ask. Please spend some time reading through this and marking any questions you want to ask your provider during the visit. You can also write other questions you want to ask on the bottom." |
|
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Question Prompt List | Behavioral | A question prompt list is a list of questions about ADHD (one page) given to study participants to select questions they may want to ask the provider. The youth question prompt list contains 22 questions, and the parent question prompt list contains 20 questions. Both are below a fourth-grade reading level. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vanderbilt Assessment Total Symptom Score (as Reported by Parent About Youth) | Vanderbilt Assessment Total Symptom Score (as reported by parent about youth) is a Diagnostic and Statistical Manual for Mental Disorders-IV-based scale, which give a Total Symptom Score. The Vanderbilt ADHD Rating Scale has been shown to have valid psychometric properties consistent with the Diagnostic and Statistical Manual for Mental Disorders; the Vanderbilt includes all the DSM-IV symptoms for ADHD. The Vanderbilt includes 18 DSM-IV symptoms that are rated on a 4-point Likert scale ranging from 0 to 3. The Total Symptom Scores (TSS) will be calculated by summing the scores on each item; summary scores can range from 0 to 54. Higher scores indicate worse symptoms. | Baseline, 6 months |
| Change in Youth Functioning Using the Vanderbilt Assessment Average Performance Score (as Reported by Parent About Youth) | The Vanderbilt average performance score (as reported by parent about youth) has 8 functional impairment items (overall school performance, reading, writing, math, relationship with parents, relationship with siblings, relationship with peers, and participation in organized activities such as team sports) measured on a 5-point Likert scale (ranging from 1 to 5). A summary score will be calculated by summing the scores and dividing by the 8 items to calculate an average performance score with a total range of 1-5. Higher scores indicate worse performance. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pediatric Quality of Life Inventory (PedsQL) | The 23-item PedsQL has strong reliability and validity when used with youth with ADHD. It measures four dimensions of the child's quality-of-life: (a) physical functioning, (b) emotional functioning, (c) social functioning, and (d) school functioning. The items are reverse scored and are transformed to a 0 to 100 scale with higher scores indicating better quality-of-life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Betsy Sleath, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
De-identified individual data that supports the final trial results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. Because this is a vulnerable population only specific de-identified data that preserves confidentiality to the extent allowed by NIMH will be shared.
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Beginning 9 and continuing for 36 months following publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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Both parents and their minor youths received the intervention(s) because both were present at the youth's medical visit, but the outcomes were only assessed for the youth with ADHD since the goal of the intervention was to improve youth outcomes. The youth with ADHD was the unit of analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Question Prompt List Only | A question prompt list is a list of questions about ADHD (one page) given to study participants to select questions they may want to ask the provider. The youth question prompt list contains 22 questions, and the parent question prompt list contains 20 questions. Both are below a fourth-grade reading level. |
| FG001 | Video Only | The 11-minute video has six themes: (a) talking to your doctor about ADHD, (b) controlling ADHD without medicine, (c) ADHD medications, (d) ADHD and school, (e) ADHD and your relationships, and (f) helping your parents understand your ADHD. |
| FG002 | Combined Question Prompt List/Video Intervention | A question prompt list is a list of questions about ADHD (one page) given to study participants to select questions they may want to ask the provider. The youth question prompt list contains 22 questions, and the parent question prompt list contains 20 questions. Both are below a fourth-grade reading level. And the video is an 11-minute video that has six themes: (a) talking to your doctor about ADHD, (b) controlling ADHD without medicine, (c) ADHD medications, (d) ADHD and school, (e) ADHD and your relationships, and (f) helping your parents understand your ADHD. |
| FG003 | Control | The control group will receive usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Question Prompt List Only | A question prompt list is a list of questions about ADHD (one page) given to study participants to select questions they may want to ask the provider. The youth question prompt list contains 22 questions, and the parent question prompt list contains 20 questions. Both are below a fourth-grade reading level. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data are reported separately for Parent or Caregivers and Youth. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Vanderbilt Assessment Total Symptom Score (as Reported by Parent About Youth) | Vanderbilt Assessment Total Symptom Score (as reported by parent about youth) is a Diagnostic and Statistical Manual for Mental Disorders-IV-based scale, which give a Total Symptom Score. The Vanderbilt ADHD Rating Scale has been shown to have valid psychometric properties consistent with the Diagnostic and Statistical Manual for Mental Disorders; the Vanderbilt includes all the DSM-IV symptoms for ADHD. The Vanderbilt includes 18 DSM-IV symptoms that are rated on a 4-point Likert scale ranging from 0 to 3. The Total Symptom Scores (TSS) will be calculated by summing the scores on each item; summary scores can range from 0 to 54. Higher scores indicate worse symptoms. | The Vanderbilt ADHD symptoms score was asked at the beginning of the study in the eligibility screening instrument, but the team did not catch that this had not been added to the 6-month questionnaire. IRB approval was obtained and participants who had already completed the 6-month interview were recontacted to ask these two questions. All collected data are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months |
From the time of signing informed consent through Month 6 Follow-Up visit, a total of up to 6 months.
All-Cause Mortality, Serious, and Other (Not including serious) adverse events were not assessed, monitored, or collected for the parents.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Question Prompt List Only | A question prompt list is a list of questions about ADHD (one page) given to study participants to select questions they may want to ask the provider. The youth question prompt list contains 22 questions, and the parent question prompt list contains 20 questions. Both are below a fourth-grade reading level. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Izabela Annis, MS | University of North Carolina at Chapel Hill | 919-962-0081 | izabela@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2026 | Apr 14, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 20, 2022 | Sep 17, 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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Youth will be randomized within provider to either the question prompt list only group (N=35), the pre-visit video only group (N=35), the combined question prompt list/video intervention group (N=35), or the control group (N=35). This will ensure group balance. The investigators are including a usual care control group because the team needs to control for the many factors that might influence communication (such as youth age, parent educational level, etc.) By randomizing families to the four groups, these factors should be evenly distributed across the groups.
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The control group will receive usual care.
|
| Video Only | Behavioral | The 11-minute video has six themes: (a) talking to your doctor about ADHD, (b) controlling ADHD without medicine, (c) ADHD medications, (d) ADHD and school, (e) ADHD and your relationships, and (f) helping your parents understand your ADHD. |
|
| Baseline, 6 months |
| BG001 |
| Video Only |
The 11-minute video has six themes: (a) talking to your doctor about ADHD, (b) controlling ADHD without medicine, (c) ADHD medications, (d) ADHD and school, (e) ADHD and your relationships, and (f) helping your parents understand your ADHD. |
| BG002 | Combined Question Prompt List/Video Intervention | A question prompt list is a list of questions about ADHD (one page) given to study participants to select questions they may want to ask the provider. The youth question prompt list contains 22 questions, and the parent question prompt list contains 20 questions. Both are below a fourth-grade reading level. And the video is an 11-minute video that has six themes: (a) talking to your doctor about ADHD, (b) controlling ADHD without medicine, (c) ADHD medications, (d) ADHD and school, (e) ADHD and your relationships, and (f) helping your parents understand your ADHD. |
| BG003 | Control | The control group will receive usual care. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Data are reported separately for Parent or Caregivers and Youth. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Data are reported separately for Parent or Caregivers and Youth. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Data are reported separately for Parent or Caregivers and Youth. | Count of Participants | Participants |
|
| Region of Enrollment | Data reported are for Youth. | Count of Participants | Participants |
|
| Region of Enrollment | Data reported are for Parents or Caregivers. | Count of Participants | Participants |
|
| Length of Time with ADHD | Data not collected for Parent or Caregiver participants. | Mean | Standard Deviation | years |
|
| ID | Title | Description |
|---|
| OG000 | Question Prompt List Only | A question prompt list is a list of questions about ADHD (one page) given to study participants to select questions they may want to ask the provider. The youth question prompt list contains 22 questions, and the parent question prompt list contains 20 questions. Both are below a fourth-grade reading level. |
| OG001 | Video Only | The 11-minute video has six themes: (a) talking to your doctor about ADHD, (b) controlling ADHD without medicine, (c) ADHD medications, (d) ADHD and school, (e) ADHD and your relationships, and (f) helping your parents understand your ADHD. |
| OG002 | Combined Question Prompt List/Video Intervention | A question prompt list is a list of questions about ADHD (one page) given to study participants to select questions they may want to ask the provider. The youth question prompt list contains 22 questions, and the parent question prompt list contains 20 questions. Both are below a fourth-grade reading level. And the video is an 11-minute video that has six themes: (a) talking to your doctor about ADHD, (b) controlling ADHD without medicine, (c) ADHD medications, (d) ADHD and school, (e) ADHD and your relationships, and (f) helping your parents understand your ADHD. |
| OG003 | Control | The control group will receive usual care. |
|
|
|
| Primary | Change in Youth Functioning Using the Vanderbilt Assessment Average Performance Score (as Reported by Parent About Youth) | The Vanderbilt average performance score (as reported by parent about youth) has 8 functional impairment items (overall school performance, reading, writing, math, relationship with parents, relationship with siblings, relationship with peers, and participation in organized activities such as team sports) measured on a 5-point Likert scale (ranging from 1 to 5). A summary score will be calculated by summing the scores and dividing by the 8 items to calculate an average performance score with a total range of 1-5. Higher scores indicate worse performance. | The Vanderbilt average performance score was asked at the beginning of the study in the eligibility screening instrument, but the team did not catch that this had not been added to the 6-month questionnaire. IRB approval was obtained and participants who had already completed the 6-month interview were recontacted to ask these two questions. All collected data are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months |
|
|
|
|
| Secondary | Change in Pediatric Quality of Life Inventory (PedsQL) | The 23-item PedsQL has strong reliability and validity when used with youth with ADHD. It measures four dimensions of the child's quality-of-life: (a) physical functioning, (b) emotional functioning, (c) social functioning, and (d) school functioning. The items are reverse scored and are transformed to a 0 to 100 scale with higher scores indicating better quality-of-life. | Data were inadvertently not collected for one participant in the Combined Question Prompt List/Video Intervention Arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Video Only | The 11-minute video has six themes: (a) talking to your doctor about ADHD, (b) controlling ADHD without medicine, (c) ADHD medications, (d) ADHD and school, (e) ADHD and your relationships, and (f) helping your parents understand your ADHD. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Combined Question Prompt List/Video Intervention | A question prompt list is a list of questions about ADHD (one page) given to study participants to select questions they may want to ask the provider. The youth question prompt list contains 22 questions, and the parent question prompt list contains 20 questions. Both are below a fourth-grade reading level. And the video is an 11-minute video that has six themes: (a) talking to your doctor about ADHD, (b) controlling ADHD without medicine, (c) ADHD medications, (d) ADHD and school, (e) ADHD and your relationships, and (f) helping your parents understand your ADHD. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Control | The control group will receive usual care. | 0 | 49 | 0 | 49 | 0 | 49 |
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|
| Male |
|
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| 0.3564 |
Models controlled for the following covariates: baseline values of the youth average performance score, youth age, and clinic. |
| Other |
| ANCOVA | 0.0526 | Models controlled for the following covariates: baseline values of the youth average performance score, youth age, and clinic. | Other |
| 0.4180 |
Models controlled for the following covariates: baseline values of the PedsQL, youth age, and clinic. |
| Other |
| ANCOVA | 0.2759 | Models controlled for the following covariates: baseline values of the PedsQL, youth age, and clinic. | Other |