Question Prompt/Video Intervention for ADHD

Overseen By Robert Christian, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: No ADHD, Age, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help kids and teens with ADHD (Attention Deficit Hyperactivity Disorder) and their parents communicate better with doctors during visits. It examines whether using question prompt lists, a short educational video, or both can improve their ability to ask questions and learn about ADHD, as well as increase their empowerment in managing the condition. Participants will be sorted into groups to try one or both tools or receive usual care. This trial is ideal for English-speaking youth aged 11-17 diagnosed with ADHD who frequently visit the doctor for it. The trial aims to determine if these tools can improve symptoms, school and social performance, and overall quality of life. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches that could enhance communication and management of ADHD for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on improving communication about ADHD rather than changing medication regimens.

What prior data suggests that this intervention is safe for improving communication about ADHD?

Research has shown that pre-visit videos and question prompt lists are generally safe for teenagers with ADHD. Studies have found that these tools encourage kids and their parents to ask more questions during doctor visits and boost their confidence in managing ADHD.

No reports of negative effects from using these videos and question lists have emerged. As they are not medicines, they do not carry the side effects that drugs might have.

Overall, these tools aim to make doctor visits more helpful and informative without any known risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve ADHD visits through communication and engagement. Unlike traditional treatments that focus on medication and behavioral therapy, this trial examines the impact of a pre-visit video and a question prompt list designed for both youth and their parents. These tools aim to empower families to actively participate in their healthcare by encouraging them to ask questions and engage with their providers. By focusing on enhancing communication, this trial could lead to more personalized and effective ADHD care.

What evidence suggests that this trial's interventions could be effective for improving communication about ADHD?

This trial will evaluate different interventions to improve communication about ADHD during doctor visits. Participants will join one of several groups. One group will use a pre-visit video, which research has shown can help young people ask more questions and learn more from their doctors about ADHD. Another group will use a list of suggested questions, specially designed to help parents and kids ask important questions during their visits. A third group will use both the video and the question list together, which studies suggest makes these visits even more effective, potentially improving ADHD symptoms and overall quality of life. Early findings indicate that these tools make doctor visits more informative and engaging for families dealing with ADHD. ^{1 2 5 6 7}

Who Is on the Research Team?

Betsy Sleath, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for English-speaking adolescents aged 11-17 with an ADHD diagnosis and their parents. Participants must be attending an ADHD visit and show specific types of ADHD on the Vanderbilt scale. Parents need to be legal guardians, over 18, and also speak English.

Inclusion Criteria

I am 11-17 years old with ADHD and fit one of the subtypes on the Vanderbilt scale.

Exclusion Criteria

Child not speaking English

I am not willing to have my medical visit recorded.

Child without ADHD

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Visit

Participants receive the intervention (question prompt list and/or video) and have their medical visits audio-tape recorded

1 day

1 visit (in-person)

3-Month Follow-up

Participants return for follow-up visits where interventions are repeated, and communication is assessed

1 day

1 visit (in-person)

6-Month Follow-up

Participants are monitored for changes in ADHD symptoms, school and social performance, and quality-of-life

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Pre-visit video
• Question prompt list

Trial Overview

The study tests if a pre-visit intervention (question prompt list/video) can improve communication about ADHD in clinical visits. It's a pilot trial with four groups: one gets both tools, another just the list, the third only the video, and the last receives usual care without these aids.

How Is the Trial Designed?

Group I: Question prompt list only group Experimental Treatment 1 Intervention

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."

Group II: Pre-visit video only group Experimental Treatment 1 Intervention

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.

Group III: Combined question prompt list/video intervention group Experimental Treatment 3 Interventions

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."

Group IV: Control group Active Control 1 Intervention

The control group will receive usual care.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The study involved 185 youth aged 11-17 who received an asthma question prompt list and video intervention, but both the intervention and usual care groups showed similar improvements in asthma control and quality of life after 12 months.

Despite the intervention not leading to significantly better outcomes compared to usual care, baseline asthma control and quality of life were important predictors of improvements over the year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a question prompt list and video intervention on teen asthma control and quality-of-life one year later: results of a randomized trial. Sleath, B., Carpenter, D., Davis, SA., et al.[2021]

A glaucoma question prompt list and educational video intervention was well-received by 189 African American patients, with 87% recommending the video and 89% supporting the use of the prompt list before medical visits.

The study found that older patients were less likely to endorse the video, while those with fewer years of education and lower adherence rated the video as more useful, suggesting that the intervention may particularly benefit certain demographic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance of a Pre-visit Intervention to Engage African American Glaucoma Patients during Visits. Sleath, B., Carpenter, DM., Davis, SA., et al.[2023]

A new question prompt list (QPL) specifically for parents of children with ADHD was developed, consisting of 88 essential questions aimed at improving communication with healthcare providers.

This QPL is the first of its kind for ADHD and was validated using the Delphi method, which involved input from both medical experts and parents, ensuring that it addresses key concerns about diagnosis, treatment, and support for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a question prompt list for parents of children with attention-deficit/hyperactivity disorder: a Delphi study. Ahmed, R., McCaffery, KJ., Aslani, P.[2019]

In a study involving 4349 patients across various outpatient clinics, providing a Digital Audio Recording (DAR) of consultations significantly improved patients' self-perceived information needs by 4.1% to 6.3%, especially regarding test results and treatment options.

The combination of a Question Prompt List (QPL) and DAR not only enhanced patients' satisfaction and their relationship with healthcare professionals but also made them feel more involved in decision-making, suggesting these tools should be integrated into routine practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital audio recordings improve the outcomes of patient consultations: A randomised cluster trial. Wolderslund, M., Kofoed, PE., Holst, R., et al.[2022]

A question prompt list (QPL) was found to significantly help parents of children with ADHD by encouraging them to ask more questions during consultations, leading to increased satisfaction and reduced anxiety about treatment decisions.

Both parents and pediatricians reported that the QPL improved communication and facilitated discussions about ADHD treatment, suggesting it could be a valuable tool in clinical practice for shared decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evaluation of a question prompt list for attention-deficit/hyperactivity disorder in pediatric care: A pilot study. Ahmed, R., McCaffery, KJ., Silove, N., et al.[2018]

A pilot study involving parents participating in 10 weekly 90-minute sessions via multi-point videoconferencing showed that most found this method useful, convenient, and satisfactory for ADHD training.

Post-intervention results indicated improvements in ADHD symptoms as measured by VADPRS scores, suggesting that videoconferencing is a feasible and effective alternative to traditional face-to-face group training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participating from homes and offices: Proof-of-concept study of multi-point videoconferencing to deliver group parent training intervention for attention-deficit/ hyperactivity disorder. Shah, R., Chakrabarti, S., Sharma, A., et al.[2019]

The asthma question prompt list with video intervention did not significantly increase the actual inclusion of youth and caregiver inputs in asthma treatment regimens during clinic visits, with only 2.5% and 3.3% of visits including youth and caregiver input, respectively.

However, the intervention did enhance youth perceptions of their providers' participatory decision-making style, leading to increased satisfaction among both youth and caregivers, particularly among white caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider use of a participatory decision-making style with youth and caregivers and satisfaction with pediatric asthma visits. Sleath, B., Carpenter, DM., Coyne, I., et al.[2022]

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