## Protocol Section
### Identification Module
**NCT ID:** NCT06438120

**Brief Title:** Chatbot-based Positive Psychology Intervention to Promote Well-being in Caregivers of Children With Autism Spectrum Disorder: a Pilot Feasibility Study

**Official Title:** Chatbot-based Positive Psychology Intervention to Promote Well-being in Caregivers of Children With Autism Spectrum Disorder: A Pilot Feasibility Study

#### Organization Study ID Info
**ID:** RD/2023/1.20
#### Organization
**Class:** OTHER
**Full Name:** Hong Kong Metropolitan University
### Status Module
#### Completion Date
**Date:** 2025-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hong Kong Metropolitan University

#### Responsible Party

**Investigator Affiliation:** Hong Kong Metropolitan University

**Investigator Full Name:** Dr Wendy Zhang Wen

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This project aims to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention.

**Detailed Description:** According to a World Health Organization report, one in 100 children is diagnosed with Autism Spectrum Disorder (ASD), which is characterized by varying degrees of disability and deviation in social communication and interaction. Half of the parents of children with ASD have reported showing depression and high levels of anxiety. Lower well-being and poor quality-of-life have also been reported. Thus, there is an urgent need to find applicable interventions to reduce depressive symptoms and promote mental health in caregivers of children with ASD.

Positive psychology intervention uses positive psychological skills, such as savoring, gratitude, forgiveness, optimism, personal strength, and attainable goals, to identify meaning and value in life events and to promote positive emotions, cognitions and behaviors. Considering the convenience, low cost and popularity of chatbot, chatbot-based positive psychology intervention will be applied in this study. A pilot feasibility study will be proposed to evaluate the feasibility of chatbot-based positive psychology intervention.

The primary objective is to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention in promoting well-being in caregivers of children with ASD (Primary).

The secondary objectives are:

To test if the intervention reduces perceived stress in caregivers of children with ASD; To test if the intervention reduces depressive symptoms of caregivers of children with ASD; To test if the intervention improves quality of life in caregivers of children with ASD.

### Conditions Module

**Conditions:**

- Autism Spectrum Disorder

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Participants will receive chatbot-based positive psychology exercises including positive introduction, personal strengths, using strengths, three good things, gratitude letter/visit, hope and optimism, active/constructive responding, and savoring.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In the intervention group, participants will receive chatbot-based positive psychology intervention.

**Intervention Names:**

- Behavioral: Chatbot-based positive psychology intervention

**Label:** Intervention group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention group

**Description:** Eight positive psychology exercises will be delivered, including positive introduction, personal strengths, using strengths, three good things, gratitude, hope and optimism, active/constructive responding, and savoring.

**Name:** Chatbot-based positive psychology intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Feasibility will be assessed by 2 items modified from the Feasibility of Intervention Measure and the semi-structured interview will be conducted after the intervention immediately (9-week follow-up). Barriers and facilitators to participant adherence, and retention will be discussed in order to collect feedback.

**Measure:** The feasibility of chatbot-based positive psychology intervention

**Time Frame:** Baseline and after the intervention immediately (8-week follow-up)

**Description:** Well-being will be measured by the World Health Organization-5 Well-being

**Measure:** The score of well-being

**Time Frame:** Baseline and after the intervention immediately (8-week follow-up)

#### Secondary Outcomes

**Description:** Perceived Stress will be assessed by a 10-item Perceived Stress Scale (PSS-10)

**Measure:** Perceived Stress

**Time Frame:** Baseline and after the intervention immediately (8-week follow-up)

**Description:** Depressive symptoms will be measured by the Patient Health Questionnaire-9 (PHQ-9)

**Measure:** Depressive symptoms

**Time Frame:** Baseline and after the intervention immediately (8-week follow-up)

**Description:** Quality of life will be measured by the Chinese version of Short Form-8(SF-8)

**Measure:** The score of Quality of life

**Time Frame:** Baseline and after the intervention immediately (8-week follow-up)

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

Primary caregivers

* (i) providing long-term care for the primary-school-age child (6-11 years old) diagnosed with ASD;
* (ii) who are over 18 years old;
* (iii) who have the ability to communicate and read in Chinese;
* (iv) who have at least one mobile phone with an internet connection.

Exclusion criteria:

Primary caregivers

* (i) who participate in a similar psychological intervention within one year;
* (ii) currently on regular psychotropic medications.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wwzhang@hkmu.edu.hk

**Name:** Wen Zhang, PhD

**Phone:** +852-3970-2945

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000065886

- Term: Neurodevelopmental Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4623

- Name: Autistic Disorder

- Relevance: HIGH

- As Found: Autism

- ID: M206

- Name: Autism Spectrum Disorder

- Relevance: HIGH

- As Found: Autism Spectrum Disorder

- ID: M5903

- Name: Child Development Disorders, Pervasive

- Relevance: HIGH

- As Found: Autism Spectrum Disorder

- ID: M5902

- Name: Developmental Disabilities

- Relevance: LOW

- As Found: Unknown

- ID: M30644

- Name: Neurodevelopmental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001321

- Term: Autistic Disorder

- ID: D000067877

- Term: Autism Spectrum Disorder

- ID: D000002659

- Term: Child Development Disorders, Pervasive

### Misc Info Module

- Version Holder: 2024-05-31
