Empowering Caregivers in ADHD Treatment: Standard Care Vs. Decision Aid, Coaching, and AI Support

Sponsor
Ariel University
Study ID
NCT06828900
Status
Enrolling By Invitation

Conditions

  • ADHD
  • ADHD, ADD
  • Shared Decision Making

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Written Decision Aid — BEHAVIORAL
    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.
  • Decision Aid + Decision Coaching — BEHAVIORAL
    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.
  • AI-Driven Support — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Feb 17, 2025
Start date
Nov 19, 2024
Status verified
Jan 2025
Primary completion
Nov 1, 2025
Completion
Nov 1, 2025

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.
  • Active Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Decisional conflict [ Time Frame: Before the intervention, 2 weeks after and 3 months after ]

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