Diagnosis Disclosure Support for Caregivers of Children With Autism

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorKorea University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Caregivers of children with significant intellectual disability

Caregivers of children with significant language delay

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Waitlist Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline, immediately after the intervention, 1-month follow-up
2

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.

Time frame
baseline, immediately after the intervention, 1-month follow-up
3

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."

Time frame
immediately after the intervention
4

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.'

Time frame
immediately after the intervention

Secondary outcomes

1

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

The Korean Version of the Internalized Stigma of Mental Illness Scale (K-ISMI) will be used to measure the level of internalized stigma experienced by caregivers and to assess the impact of stigma on family stress and adaptation. Items are rated on a 4-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (4), with reverse-scored items included. Total scores range from 29 to 116, with higher scores indicating a higher level of internalized stigma related to having a child with autism.

Time frame
baseline, immediately after the intervention, 1-month follow-up
2

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

The Life Transition Scale for Parents of Children with Autism (LTS) will be used to assess the emotional responses and psychological adaptation of caregivers of autistic children during the process of recognizing and accepting their child's diagnosis. Items are rated on a 4-point Likert scale ranging from "never" (1) to "often" (4), with reverse-scored items included. Evaluation of the transition process is conducted by calculating the mean score for each stage, obtained by dividing the sum of item scores within each stage by the number of items; higher or lower mean scores are then compared across stages.

Time frame
baseline, immediately after the intervention, 1-month follow-up
3

Emotion Regulation Questionnaire (ERQ)

The Emotion Regulation Questionnaire (ERQ) will be used to assess how caregivers experience and regulate their emotions in their daily lives. Items are rated on a 7-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (7). Higher scores indicate greater use of the corresponding emotion regulation strategy.

Time frame
baseline, immediately after the intervention, 1-month follow-up
4

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

The Autism Stigma and Knowledge Questionnaire (ASK-Q-2) will be used to assess caregivers' knowledge of and stigma toward autism. Items are scored dichotomously (agree = 1, disagree = 0).

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Korea University

Lead sponsor

National Research Foundation of Korea

Collaborator

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