Empowering Caregivers in ADHD Treatment Decisions: a Four-arm Randomized Controlled Trial Comparing Standard Care, a Decision Aid, Decision Coaching, and AI-driven Support
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Ariel University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Decisional conflict
Study Overview
Brief Summary
The goal of this clinical trial is to evaluate different decision-support interventions to help parents make informed treatment decisions for their children with ADHD. The study will compare four approaches to assess their impact on decision-making quality, decisional conflict, and treatment adherence among parents of children aged 6-17 years diagnosed with ADHD.
The main questions it aims to answer are:
Does providing parents with decision-support tools improve decision-making quality compared to standard care? Do decision aid, decision aid + decision coaching, and AI-driven support further enhance parental self-efficacy, knowledge, and adherence to treatment decisions?
Standard care (physician consultation only) A written decision aid (structured booklet) Decision aid + decision coaching (booklet + one-on-one coaching session) AI-driven support (interaction with an AI tool)
Participants will:
Complete a baseline questionnaire before the intervention Receive their assigned decision-support intervention (if applicable) Complete follow-up questionnaires at 2 weeks and 3 months after the intervention Report on treatment decisions and medication adherence over 3 months This study will determine whether structured decision aids, coaching, or AI-driven tools improve parental decision-making and treatment adherence in ADHD care.
Detailed Description
This randomized controlled trial (RCT) aims to evaluate the effectiveness of different decision-support interventions in helping parents of children with ADHD make informed treatment decisions. The study will assess the impact of structured decision aids, decision coaching, and AI-driven support on parental decision-making quality, decisional conflict, self-efficacy, knowledge, and treatment adherence. Participants will be randomly assigned to one of four study arms: standard care, a written decision aid, decision aid plus decision coaching, or AI-driven support. Outcomes will be measured at baseline, two weeks, and three months post-intervention.
Rationale
ADHD is a common neurodevelopmental disorder affecting children worldwide. Treatment options primarily include medication or no medication, each with associated risks and benefits. Shared Decision Making (SDM) is recognized as a best-practice model, ensuring treatment decisions align with parental values and preferences. However, parents often face challenges in weighing options, understanding treatment effects, and feeling confident in their decisions. This study seeks to compare decision-support interventions to determine their effectiveness in enhancing decision-making quality, reducing decisional conflict, and improving parental knowledge and treatment adherence.
Study Design
This is a four-arm, parallel-group, randomized controlled trial. Participants will be randomly assigned in a 1:1:1:1 ratio to one of four arms:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Parents or legal guardians of children aged 6-17 diagnosed with ADHD.
- •Able to provide informed consent.
- •Willing to participate in all study activities, including follow-up assessments.
Exclusion Criteria
- •Non-Hebrew-speaking parents (due to the language-based intervention materials).
- •Parents who have previously participated in ADHD decision aid trials.
- •Parent of children with severe comorbid psychiatric conditions requiring urgent psychiatric care
Arms & Interventions
Control (Standard Care)
Participants will undergo the typical clinical consultation process for ADHD treatment decisions without additional decision support interventions. Parents will meet with a physician who will present the available treatment options, based on standard clinical guidelines. The physician will answer any questions parents may have but will not use structured decision aids, coaching, or AI-driven tools. Parents will then make a treatment decision based on this discussion. This approach reflects real-world clinical encounters where parents rely solely on physician-provided information.
Intervention: Decision Aid + Decision Coaching (Behavioral)
Control (Standard Care)
Participants will undergo the typical clinical consultation process for ADHD treatment decisions without additional decision support interventions. Parents will meet with a physician who will present the available treatment options, based on standard clinical guidelines. The physician will answer any questions parents may have but will not use structured decision aids, coaching, or AI-driven tools. Parents will then make a treatment decision based on this discussion. This approach reflects real-world clinical encounters where parents rely solely on physician-provided information.
Intervention: AI-Driven Support (Behavioral)
Control (Standard Care)
Participants will undergo the typical clinical consultation process for ADHD treatment decisions without additional decision support interventions. Parents will meet with a physician who will present the available treatment options, based on standard clinical guidelines. The physician will answer any questions parents may have but will not use structured decision aids, coaching, or AI-driven tools. Parents will then make a treatment decision based on this discussion. This approach reflects real-world clinical encounters where parents rely solely on physician-provided information.
Intervention: Written Decision Aid (Behavioral)
AI-Driven Support
Participants will interact with a large language model-based AI tool (Claude) to assist in their decision-making process regarding medication vs. no medication for ADHD treatment. This AI-driven intervention is designed to provide structured, personalized decision support while maintaining an unbiased, evidence-based approach.
Participants will receive 10 structured prompts to ask the AI, covering key aspects of ADHD treatment (e.g., benefits and risks of medication, long-term outcomes, alternatives).
Following this structured phase, participants will have 15 minutes of free interaction with the AI to explore any remaining questions or concerns.
At the end of the session, they will receive a summary output of their AI interactions to review.
The AI tool is designed to translate complex medical information into user-friendly language, provide comparative treatment insights, and help parents clarify their values and concerns. However, it will not offer direct medical recommendations.
Intervention: Written Decision Aid (Behavioral)
AI-Driven Support
Participants will interact with a large language model-based AI tool (Claude) to assist in their decision-making process regarding medication vs. no medication for ADHD treatment. This AI-driven intervention is designed to provide structured, personalized decision support while maintaining an unbiased, evidence-based approach.
Participants will receive 10 structured prompts to ask the AI, covering key aspects of ADHD treatment (e.g., benefits and risks of medication, long-term outcomes, alternatives).
Following this structured phase, participants will have 15 minutes of free interaction with the AI to explore any remaining questions or concerns.
At the end of the session, they will receive a summary output of their AI interactions to review.
The AI tool is designed to translate complex medical information into user-friendly language, provide comparative treatment insights, and help parents clarify their values and concerns. However, it will not offer direct medical recommendations.
Intervention: Decision Aid + Decision Coaching (Behavioral)
Decision Aid + Decision Coaching
Participants will receive the written decision aid booklet, developed based on IPDAS guidelines, along with a one-on-one decision coaching session. The decision coaching will follow a structured script based on the Ottawa Personal Decision Guide (OPDG), refined through training with the principal investigator (PI). The decision coach will not give medical advice but will help parents clarify their values, address uncertainties, and weigh the benefits and risks of medication vs. no medication. Through guided value clarification exercises, parents will explore their concerns and preferences to make a well-informed decision.
Intervention: AI-Driven Support (Behavioral)
Decision Aid + Decision Coaching
Participants will receive the written decision aid booklet, developed based on IPDAS guidelines, along with a one-on-one decision coaching session. The decision coaching will follow a structured script based on the Ottawa Personal Decision Guide (OPDG), refined through training with the principal investigator (PI). The decision coach will not give medical advice but will help parents clarify their values, address uncertainties, and weigh the benefits and risks of medication vs. no medication. Through guided value clarification exercises, parents will explore their concerns and preferences to make a well-informed decision.
Intervention: Written Decision Aid (Behavioral)
Written Decision Aid
Participants will receive a structured booklet developed based on IPDAS guidelines to support informed decision-making regarding medication vs. no medication for ADHD treatment. The booklet provides a clear explanation of ADHD, the role of medication, and the option of not using medication, including the potential benefits, risks, and uncertainties of each choice. It presents evidence-based information in a balanced manner, helping parents understand possible outcomes such as symptom management, side effects, and long-term considerations. The booklet also includes value clarification exercises to help parents align their decision with personal preferences and concerns.
Intervention: Decision Aid + Decision Coaching (Behavioral)
Written Decision Aid
Participants will receive a structured booklet developed based on IPDAS guidelines to support informed decision-making regarding medication vs. no medication for ADHD treatment. The booklet provides a clear explanation of ADHD, the role of medication, and the option of not using medication, including the potential benefits, risks, and uncertainties of each choice. It presents evidence-based information in a balanced manner, helping parents understand possible outcomes such as symptom management, side effects, and long-term considerations. The booklet also includes value clarification exercises to help parents align their decision with personal preferences and concerns.
Intervention: AI-Driven Support (Behavioral)
Outcomes
Primary Outcomes
Decisional conflict
Time Frame: Before the intervention, 2 weeks after and 3 months after
Decisional conflict refers to the uncertainty parents experience when making treatment decisions for their child, particularly when weighing the benefits and risks of medication versus no medication for ADHD. It reflects how informed they feel about their options, how clear they are about their values, and how supported they feel in the decision-making process. Higher decisional conflict scores indicate greater uncertainty, confusion, or lack of confidence, suggesting that parents may feel uninformed, pressured, or unsure about which option aligns best with their values and preferences. A reduction in decisional conflict over time suggests that parents have gained clarity, confidence, and a better understanding of their options, leading to a more informed and satisfactory decision. This change is a key indicator of the effectiveness of decision-support interventions in helping parents navigate ADHD treatment choices.
Decision-Making Quality
Time Frame: 2 weeks and 3 months after the intervention
he Decision-Making Quality Scale (DMQS) assesses the extent to which a parent's decision is informed, aligned with their values, and consistent with SDM principles. The DMQS evaluates how thoroughly an individual considers alternatives, gathers and integrates relevant information, and deliberates before making a final choice . Higher scores on the DMQS indicate a higher-quality decision-making process, characterized by greater knowledge about the decision at hand, a more deliberate weighing of risks and benefits, and stronger alignment between the chosen option and the individual's values. Conversely, lower scores suggest a decision that is less informed, potentially rushed, or influenced by external pressures rather than a systematic evaluation of options . This measure is crucial in ADHD treatment decision-making, as it captures the degree to which parents engage in a thoughtful and well-supported choice regarding their child's care.
Secondary Outcomes
- Knowledge(Before the intervention, 2 weeks after and 3 months after)
- Parents' values(2 weeks and 3 months after the intervention)
- Health literacy(Before the intervention)
- Numeracy(Before the intervention)
- Decision self efficacy(Before the intervention, 2 weeks and 3 months after)
- ADHD care(3 months after the intervention)
- Preparation for decision-making(Before the intervention, 2 weeks after the intervention)
- Preference for SDM(2 weeksf after the intervention)
- Demographics(Before the intervention)
Investigators
Yulia Gendler
Principal Investigator, Head of Nursing Department, Ariel University, Israel
Ariel University