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

140 Participants Needed

Trial Summary

What is the purpose of this trial?

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. Teh 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, parent, and provider 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.

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 data supports the effectiveness of the treatment for ADHD?

Research shows that using a question prompt list and video before medical visits can help parents of children with ADHD feel more informed and empowered to ask questions, similar to how it has been effective for other conditions like glaucoma and asthma. ^{1 2 3 4 5}

How is the pre-visit video and question prompt list treatment for ADHD different from other treatments?

This treatment is unique because it uses a video and a list of questions to help parents communicate better with doctors and make informed decisions about ADHD treatments, unlike traditional treatments that often focus on medication. ^{3 4 5 6 7}

Research Team

Betsy Sleath, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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.

I am over 18, speak English, and am the legal guardian of my child.

Exclusion Criteria

Child without ADHD

Child not seeing a provider at the clinic participating in the study

Child not speaking English

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Digital audio recordings improve the outcomes of patient consultations: A randomised cluster trial. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Provider use of a participatory decision-making style with youth and caregivers and satisfaction with pediatric asthma visits. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The evaluation of a question prompt list for attention-deficit/hyperactivity disorder in pediatric care: A pilot study. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Acceptance of a Pre-visit Intervention to Engage African American Glaucoma Patients during Visits. [2023]

5. England 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. [2019]

6. England 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. [2021]

7. Netherlands 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. [2019]