Diagnosis Disclosure Support for Caregivers of Children With Autism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHARE : Supporting Honest Autism Recognition and Education, One-session seminar.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 7 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diagnosis Disclosure Support Intervention Program for Caregivers of Children With ASD
Overview
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.
Interventions
- Behavioral 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. Th - 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.
Primary outcome measures
- Parental Autism Disclosure Scale (PADS) [Time frame: baseline, immediately after the intervention, 1-month follow-up]
- Decisional Conflict Scale (DCS) [Time frame: baseline, immediately after the intervention, 1-month follow-up]
- Diagnosis Disclosure Support Intervention Program Acceptability Survey [Time frame: immediately after the intervention]
- Diagnosis Disclosure Support Intervention Program Feasibility Survey [Time frame: immediately after the intervention]
- Participation Survey [Time frame: during each of the five sessions (weeks 1 to 5) in intervention program]
- Intervention Fidelity Checklist [Time frame: every 3 months from the start of the intervention for each therapist]
Secondary outcome measures (9)
- Korean Version of Internalized Stigma of Mental Illness Scale (K-ISMI) [Time frame: baseline, immediately after the intervention, 1-month follow-up]
- Life Transition Scale for Parents of Children with Autism (LTS) [Time frame: baseline, immediately after the intervention, 1-month follow-up]
- Emotion Regulation Questionnaire (ERQ) [Time frame: baseline, immediately after the intervention, 1-month follow-up]
- Autism Stigma and Knowledge Questionnaire (ASK-Q-2) [Time frame: baseline, immediately after the intervention, 1-month follow-up]
- Parenting Sense of Competence (PSOC) [Time frame: baseline, immediately after the intervention, 1-month follow-up]
- Parent Satisfaction Scale (PSS) [Time frame: baseline, immediately after the intervention, 1-month follow-up]
- Korean Parenting Stress Index Fourth Edition Short Form (K-PSI-4-SF) [Time frame: baseline, immediately after the intervention, 1-month follow-up]
- UCLA Loneliness Scale-8 (ULS-8) [Time frame: baseline, immediately after the intervention, 1-month follow-up]
- Loneliness and Social Isolation Scale (LSIS) [Time frame: baseline, immediately after the intervention, 1-month follow-up]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07328438 · IRB-2025-0578-01 · 00209635