Diagnosis Disclosure Support for Caregivers of Children With Autism

NCT ID: NCT07328438

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2027-04-30

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.

Detailed Description

As school-aged children with autism spectrum disorder begin to recognize differences between themselves and their neurotypical peers, they develop questions regarding their identity and belonging. During this critical developmental period, receiving a clear and supportive explanation of their diagnosis can promote self-understanding, encourage self-advocacy, and enhance psychosocial adjustment. However, caregivers often face significant barriers to disclosing the diagnosis, stemming from fear of stigma, uncertainty about appropriate timing and language, and concerns about causing emotional distress. As a result, caregivers may delay or avoid disclosure, despite potential benefits for the child. Therefore, developing evidence-based interventions to support caregivers in diagnosis disclosure is significant, yet few studies offer guidance for caregivers, leaving disclosure decisions and processes largely to individual families.

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 ASD in South Korea, a developmental period when children go through increasing cognitive, social, and identity-related challenges. This study pursues three objectives: (1) to evaluate the acceptability and feasibility of the diagnosis disclosure support intervention; (2) to examine clinically meaningful effects on caregiver's outcomes across domains such as psychological well-being and psychosocial adjustment, parenting competence and attitudes, and autism-related knowledge and social perceptions; and (3) to assess the sustainability of these effects through a one-month follow-up after program completion.

40 caregivers of children with ASD enrolled in mainstream schools (grades 2-6) in South Korea will be recruited and randomly assigned to either an intervention group (n=20) or a waitlist control group (n=20). The intervention group will participate in a five-week, online group-based diagnosis disclosure support program consisting of weekly 60-minute sessions, which will be recorded for fidelity monitoring. The waitlist control group will receive an abbreviated one-session online seminar and program materials upon completion of the final follow-up assessment. Both groups will complete online self-report measures at three timepoints: baseline (T1), immediately following the intervention group's program completion (T2), and at a one-month follow-up (T3). This study holds the potential to improve caregivers' well-being and support healthy family communication by providing evidence-based guidance to facilitate developmentally appropriate disclosure for children with ASD in South Korea.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

SHARE : Supporting Honest Autism Recognition and Education

Intervention Type: 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.

Waitlist Control Group

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.

Group Type: ACTIVE_COMPARATOR

One-session seminar

Intervention Type: 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.

Interventions

SHARE : Supporting Honest Autism Recognition and Education

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 Type: BEHAVIORAL

One-session seminar

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Foundation of Korea

OTHER

Sponsor Role: collaborator

Korea University

OTHER

Sponsor Role: lead

Responsible Party

So Hyun Kim

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

So Hyun Kim, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Korea University

Kyoung Hong, Ph.D.

Role: STUDY_DIRECTOR

Korea University

Central Contacts

So Hyun Kim, Ph.D.

Role: CONTACT

sohkim@korea.ac.kr

+82-2-3290-2065

Other Identifiers

00209635

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-2025-0578-01

Identifier Type: -

Identifier Source: org_study_id