NCT06828900

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

February 17, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

February 5, 2025

Last Update Submit

February 13, 2025

Conditions

ADHDADHD, ADDShared Decision Making

Keywords

ADHDShared decision makingDecision aidsDecision coachingAI-driven supportADHD medical treatment

Outcome Measures

Primary Outcomes (2)

  • Decisional conflict

    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.

    Before the intervention, 2 weeks after and 3 months after

  • Decision-Making Quality

    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.

    2 weeks and 3 months after the intervention

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (4)

Control (Standard Care)

ACTIVE COMPARATOR

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.

Behavioral: Written Decision AidBehavioral: Decision Aid + Decision CoachingBehavioral: AI-Driven Support

AI-Driven Support

ACTIVE COMPARATOR

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.

Behavioral: Written Decision AidBehavioral: Decision Aid + Decision Coaching

Decision Aid + Decision Coaching

ACTIVE COMPARATOR

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.

Behavioral: Written Decision AidBehavioral: AI-Driven Support

Written Decision Aid

ACTIVE COMPARATOR

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.

Behavioral: Decision Aid + Decision CoachingBehavioral: AI-Driven Support

Interventions

Written Decision AidBEHAVIORAL

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.

Also known as: PtDA
AI-Driven SupportControl (Standard Care)Decision Aid + Decision Coaching
Decision Aid + Decision CoachingBEHAVIORAL

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 SupportControl (Standard Care)Written Decision Aid
AI-Driven SupportBEHAVIORAL

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.

Control (Standard Care)Decision Aid + Decision CoachingWritten Decision Aid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ariel University

Ariel, Israel, 407000, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Yulia Gendler, PhD

    'MyHealthAid' research lab - Ariel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Head of Nursing Department, Ariel University, Israel

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 17, 2025

Study Start

November 19, 2024

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

February 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) supporting the findings of this study will be made available upon reasonable request. Data will be accessible to qualified researchers affiliated with academic or non-profit institutions, subject to approval. Requests should be submitted to yuliage@ariel.ac.il. Data will be stored in Open Science Framework (OSF) to ensure secure and long-term access. The dataset will be available for 5 years post-publication. Researchers must agree to a data use agreement (DUA) specifying ethical usage, proper citation, and compliance with institutional review board (IRB) requirements for secondary use.

Locations

IL(1)