Diagnosis Disclosure Support for Caregivers of Children With Autism

NCT07328438 | Not Yet Recruiting

• 2 other identifiers: IRB-2025-0578-0100209635
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this randomized controlled pilot study is to develop and evaluate an online diagnosis disclosure support intervention for caregivers of 7- to 12-year-old children with autism spectrum disorder (ASD) in South Korea. This intervention is designed to support caregivers who are contemplating, preparing for, or carrying out disclosure of their child's ASD diagnosis to the child. This study has three primary aims: (1) to evaluate the acceptability and feasibility of the intervention; (2) to examine clinically meaningful effects of the intervention on caregivers' psychological well-being and psychosocial adjustment (e.g., emotion regulation, loneliness/social isolation, and adaptation to life transitions), parenting competence and attitudes (e.g., parenting self-efficacy, parenting role satisfaction, and parenting stress), and autism-related knowledge and social perceptions (e.g., autism knowledge and perceived autism-related stigma); and (3) to assess whether the effects of the intervention are maintained one month after program completion.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (6)

• Parental Autism Disclosure Scale (PADS)

  The Parental Autism Disclosure Scale (PADS) is a self-report instrument developed in this study to measure the extent to which caregivers of autistic children have considered and prepared for disclosing the diagnosis to their child. The scale consists of 26 items rated on a 5-point Likert scale ranging from "strongly disagree" (0) to "strongly agree" (4), with reverse-scored items included. Higher total scores indicate greater consideration of and preparedness for disclosing the diagnosis to the child, with total scores ranging from 0 to 104.

  baseline, immediately after the intervention, 1-month follow-up

• Decisional Conflict Scale (DCS)

  The Decisional Conflict Scale (DCS) will be used to assess decision-making conflict regarding diagnosis disclosure among caregivers of children with autism. Items are rated on a 5-point Likert scale ranging from "strongly agree" (0) to "strongly disagree" (4). Total scores and subscale scores are converted to a 0-100 scale, with higher scores indicating greater decisional conflict.

  baseline, immediately after the intervention, 1-month follow-up

• Diagnosis Disclosure Support Intervention Program Acceptability Survey

  This will be used to assess whether the intervention program was satisfying and comprehensible to caregivers. Caregivers will respond to approximately 10 items using a Likert-type scale. The survey will include items such as "The program fits the goals of the intervention" and "The skills taught in the program are relevant to my needs."

  immediately after the intervention

• Diagnosis Disclosure Support Intervention Program Feasibility Survey

  This will be used to assess whether the intervention program was feasible for the caregivers. Caregivers will respond to approximately 10 items using a Likert-type scale. The survey will include items related to the practicality of the program such as 'Using Zoom for the sessions was easy for me.' and 'The length of each session was manageable.'

  immediately after the intervention

• Participation Survey

  A form will be used to record the attendance of the caregivers as a measure of their participation in the intervention program.

  during each of the five sessions (weeks 1 to 5) in intervention program

• Intervention Fidelity Checklist

  This will be used to assess whether core elements in each session were delivered to caregivers. Interventionists will record the checklist for each session.

  every 3 months from the start of the intervention for each therapist

Secondary Outcomes (9)

• Korean Version of Internalized Stigma of Mental Illness Scale (K-ISMI)

  baseline, immediately after the intervention, 1-month follow-up

• Life Transition Scale for Parents of Children with Autism (LTS)

  baseline, immediately after the intervention, 1-month follow-up

• Emotion Regulation Questionnaire (ERQ)

  baseline, immediately after the intervention, 1-month follow-up

• Autism Stigma and Knowledge Questionnaire (ASK-Q-2)

  baseline, immediately after the intervention, 1-month follow-up

• Parenting Sense of Competence (PSOC)

  baseline, immediately after the intervention, 1-month follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

Caregivers will participate in an online diagnosis disclosure support intervention delivered via telehealth over five weekly 60-minute group sessions. This program is designed to support caregivers' decision-making and communication regarding disclosure of an ASD diagnosis to their child, including key considerations for disclosure and the development of an individualized narrative to explain the diagnosis. Sessions will include psychoeducation and interactive activities to promote engagement and skill practice.

Behavioral: SHARE : Supporting Honest Autism Recognition and Education

Waitlist Control Group

ACTIVE COMPARATOR

A one-session, group-based psychoeducational seminar delivered via telehealth will be provided to the control group. This abbreviated session will provide a condensed overview of the SHARE program, and caregivers will receive the complete SHARE program materials.

Behavioral: One-session seminar

Interventions

SHARE : Supporting Honest Autism Recognition and Education BEHAVIORAL

Our intervention will consist of a five-week, telehealth-based group intervention (60 minutes per week) to support caregivers of children with ASD (7- to 12-year-olds) regarding diagnosis disclosure. This program provides guidance on the rationale for disclosure, strategies for initiating conversations, and the understanding that disclosure is a gradual, lifelong journey. In addition, the program helps caregivers customize disclosure based on their child's development and emotional readiness. The curriculum moves beyond didactic instruction by combining psychoeducation with experiential, participant-centered activities to support practice and application.

Intervention Group

One-session seminar BEHAVIORAL

The control group will receive a 60-minute telehealth seminar providing a condensed overview of the SHARE program and the complete set of SHARE program materials.

Waitlist Control Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Caregivers of children aged 7-12 (Grades 2-6) attending mainstream schools in South Korea
• Caregivers of children with previous medical diagnosis of ASD
• Caregivers with no prior experience of participation in diagnosis disclosure support programs
• Caregivers in agreement with the need for a ASD diagnosis disclosure support intervention program, with commitment to continuous and sincere participation

You may not qualify if:

• Caregivers of children with significant intellectual disability
• Caregivers of children with significant language delay

Sponsors & Collaborators

• Korea University: lead
• National Research Foundation of Korea: collaborator

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• So Hyun Kim, Ph.D.

  Korea University

  PRINCIPAL INVESTIGATOR

• Kyoung Hong, Ph.D.

  Korea University

  STUDY DIRECTOR

Central Study Contacts

So Hyun Kim, Ph.D.

CONTACT

+82-2-3290-2065; sohkim@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Waitlist Control Group Design

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 9, 2026
• Study Start: January 5, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01