search
Back to results

Telehealth Parent Coaching to Improve Activity Participation for Young Children With ASD and SPD

Primary Purpose

Sensory Processing Disorder, Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
parent coaching via telehealth
weekly self-learning materials and group discussion session
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensory Processing Disorder focused on measuring Sensory Processing Disorder, Parent-mediated intervention, Autism Spectrum Disorder, Parent Coaching via Telehealth

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The child is 3 to 5 years old The child is diagnosed with ASD by a child psychiatrist or specialist in psychology based on the DSM-5's diagnostic criteria The child's score falls within the category of dysfunction in one or more sensory processing functions in the Sensory Profile (3-10 years old version) Exclusion Criteria: Children diagnosed with major neuromuscular dysfunction or other disease diagnoses, such as epilepsy or other genetic diseases Children whose parents could not speak Hokkenese or Chinese and read in Chinese Individuals who have participated in the first year of this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Single subject experiment

    RCT, Treatment group

    RCT, Active Comparator

    Arm Description

    Each participant will first receive one-hour, one-on-one parent-child interaction strategy coaching every week via Telehealth until the parent's parent-child interaction skills and the child's social communication abilities reach a stable or upward trend, and the parent's sensory processing strategy utilization ability and the child's daily life participation scores that are continuously collected shows a stable or downward trend. After which, the one-hour, one-on-one sensory processing strategy coaching (C1) will be provided every week via Telehealth until the parent's sensory processing strategy utilization ability and the child's activity participation level reaches a stable trend.

    Participant receive 12 weeks of sensory processing strategy coaching and parent-child interaction strategy coaching intervention.

    Participant will be provided with weekly self-learning materials and group discussion session for 12 weeks.

    Outcomes

    Primary Outcome Measures

    The performance and satisfaction with the child's daily participation
    Measured by the Canadian Occupational Performance Measure in the RCT experiment. The score could range from 1 to 10, with higher scores implied greater performance and higher satisfaction with the child's daily participation.
    The parent's parent-child interaction strategy utilization
    Measured by the self-developed measurement - the Parental Parent-Child Interaction Strategy Rating Scale in the single subject experiment. The score could range from 20 to 80, with higher scores implied greater parent-child interaction strategy utilization.
    The child's social communication ability
    Measured by the self-developed measurement - the Social Communication Rating Scale for young children in the single subject experiment. The score could range from 0 to 38, with higher scores implied greater social communication ability.

    Secondary Outcome Measures

    The social functioning and adaptive behavior of the child
    Measured by the Vineland Adaptive Behavior Scales - Third Edition in the RCT experiment. The score could range from 20 to 160, with higher scores implied greater social functioning and adaptive behavior.
    The attainment of the selected goal related to issues with the child's sensory processing disorder
    Measured by the Goal Attainment Scale in the RCT experiment. The score could range from -2 to 2, with higher scores implied greater attainment of the selected goal related to issues with the child's sensory processing disorder.
    The attainment of the selected goal related to issues with the child's sensory processing disorder
    Measured by the Goal Attainment Scale in the single subject experiment. The score could range from -2 to 2, with higher scores implied greater attainment of the selected goal related to issues with the child's sensory processing disorder.
    The child's performance in social communication
    Measured by the Brief Observation of Social Communication Change in the RCT experiment. The score could range from 0 to 85, with higher scores implied greater social communication performance.
    The parent's self-perceived parental competence
    Measured by the Parenting Sense of Competence Scale in the RCT experiment. The score could range from 17 to 102, with higher scores implied greater self-perceived parental competence.
    The parent's self-perceived parental competence
    Measured by the Parenting Sense of Competence Scale in the single subject experiment. The score could range from 17 to 102, with higher scores implied greater self-perceived parental competence.
    The parent's self-perceived stress within the family system
    Measured by the Parenting Stress Index - Short Form in the RCT experiment. The score could range from 35 to 175, with higher scores implied greater self-perceived stress within the family system
    The parent's self-perceived life quality within the last two weeks
    Measured by the WHOQOL-BREF - Taiwan version in the RCT experiment. The score could range from 4 to 20 in each domain, with higher scores implied greater self-perceived life quality within the last two weeks
    The child's social communication ability
    Measured by the self-developed measurement - the Social Communication Rating Scale for young children in the RCT experiment. The score could range from 0 to 38, with higher scores implied greater social communication ability
    The parent's parent-child interaction strategy utilization
    Measured by the self-developed measurement - the Parental Parent-Child Interaction Strategy Rating Scale in the RCT experiment. The score could range from 20 to 80, with higher scores implied greater parent-child interaction strategy utilization.
    The performance and satisfaction with the child's daily participation
    Measured by the Canadian Occupational Performance Measure in the single subject experiment. The score could range from 1 to 10, with higher scores implied greater performance or higher satisfaction with the child's daily participation.

    Full Information

    First Posted
    September 28, 2023
    Last Updated
    October 19, 2023
    Sponsor
    National Taiwan University Hospital
    Collaborators
    National Science and Technology Council, National Taiwan University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06079632
    Brief Title
    Telehealth Parent Coaching to Improve Activity Participation for Young Children With ASD and SPD
    Official Title
    Telehealth Parent Coaching to Improve Activity Participation for Young Children With Autism Spectrum Disorder and Sensory Processing Disorders: A Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    July 2025 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital
    Collaborators
    National Science and Technology Council, National Taiwan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This clinical trial aims to develop parent-child interaction strategy coaching and sensory processing strategy coaching via Telehealth and examine the feasibility and efficacy of the interventions in young children with autism spectrum disorder who have sensory processing disorder. In the first experiment, the investigators will apply a single-subject research design and one-group pre-post test design to explore the feasibility of the coaching interventions. In the second experiment, RCT design will be used to examine the effectiveness of parent coaching. Sixty-five children with ASD and their parents will be randomly assigned to the intervention or control group. The intervention group will receive weekly parent-child interaction and sensory processing strategy coaching for 12 weeks. The control group will be provided with weekly self-learning materials and group discussion session for 12 weeks. Additionally, the follow-up test will be administered three months after the intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sensory Processing Disorder, Autism Spectrum Disorder
    Keywords
    Sensory Processing Disorder, Parent-mediated intervention, Autism Spectrum Disorder, Parent Coaching via Telehealth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    In the first experiment, multiple baseline design will be used to examine the feasibility of the interventions. Each participant will first receive parent-child interaction strategy coaching every week via Telehealth, followed by sensory processing strategy coaching (C1) provided every week via Telehealth. In the second experiment, RCT design will be applied to explore the efficacy of the interventions. Participants will be randomly allocated to the treatment group or the control group. The intervention group will receive weekly, one-on-one parent-child interaction and sensory processing strategy coaching via Telehealth for 12 weeks. The control group will be provided with weekly self-learning materials and group discussion session for 12 weeks. Measures will be taken at pre-test, post-test, and 3-month follow-up.
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    68 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single subject experiment
    Arm Type
    Experimental
    Arm Description
    Each participant will first receive one-hour, one-on-one parent-child interaction strategy coaching every week via Telehealth until the parent's parent-child interaction skills and the child's social communication abilities reach a stable or upward trend, and the parent's sensory processing strategy utilization ability and the child's daily life participation scores that are continuously collected shows a stable or downward trend. After which, the one-hour, one-on-one sensory processing strategy coaching (C1) will be provided every week via Telehealth until the parent's sensory processing strategy utilization ability and the child's activity participation level reaches a stable trend.
    Arm Title
    RCT, Treatment group
    Arm Type
    Experimental
    Arm Description
    Participant receive 12 weeks of sensory processing strategy coaching and parent-child interaction strategy coaching intervention.
    Arm Title
    RCT, Active Comparator
    Arm Type
    Active Comparator
    Arm Description
    Participant will be provided with weekly self-learning materials and group discussion session for 12 weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    parent coaching via telehealth
    Intervention Description
    Participants receive 12 weeks of parent-child interaction strategy coaching and sensory processing strategy coaching intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    weekly self-learning materials and group discussion session
    Intervention Description
    Participants receive 1-hour self-learning materials, including parent-child interaction and sensory processing strategies, and 1-hour remote group discussion session weekly.
    Primary Outcome Measure Information:
    Title
    The performance and satisfaction with the child's daily participation
    Description
    Measured by the Canadian Occupational Performance Measure in the RCT experiment. The score could range from 1 to 10, with higher scores implied greater performance and higher satisfaction with the child's daily participation.
    Time Frame
    up to 25 weeks
    Title
    The parent's parent-child interaction strategy utilization
    Description
    Measured by the self-developed measurement - the Parental Parent-Child Interaction Strategy Rating Scale in the single subject experiment. The score could range from 20 to 80, with higher scores implied greater parent-child interaction strategy utilization.
    Time Frame
    through study completion, an average of 4 months
    Title
    The child's social communication ability
    Description
    Measured by the self-developed measurement - the Social Communication Rating Scale for young children in the single subject experiment. The score could range from 0 to 38, with higher scores implied greater social communication ability.
    Time Frame
    through study completion, an average of 4 months
    Secondary Outcome Measure Information:
    Title
    The social functioning and adaptive behavior of the child
    Description
    Measured by the Vineland Adaptive Behavior Scales - Third Edition in the RCT experiment. The score could range from 20 to 160, with higher scores implied greater social functioning and adaptive behavior.
    Time Frame
    up to 25 weeks
    Title
    The attainment of the selected goal related to issues with the child's sensory processing disorder
    Description
    Measured by the Goal Attainment Scale in the RCT experiment. The score could range from -2 to 2, with higher scores implied greater attainment of the selected goal related to issues with the child's sensory processing disorder.
    Time Frame
    up to 25 weeks
    Title
    The attainment of the selected goal related to issues with the child's sensory processing disorder
    Description
    Measured by the Goal Attainment Scale in the single subject experiment. The score could range from -2 to 2, with higher scores implied greater attainment of the selected goal related to issues with the child's sensory processing disorder.
    Time Frame
    through study completion, an average of 4 months
    Title
    The child's performance in social communication
    Description
    Measured by the Brief Observation of Social Communication Change in the RCT experiment. The score could range from 0 to 85, with higher scores implied greater social communication performance.
    Time Frame
    up to 25 weeks
    Title
    The parent's self-perceived parental competence
    Description
    Measured by the Parenting Sense of Competence Scale in the RCT experiment. The score could range from 17 to 102, with higher scores implied greater self-perceived parental competence.
    Time Frame
    up to 25 weeks
    Title
    The parent's self-perceived parental competence
    Description
    Measured by the Parenting Sense of Competence Scale in the single subject experiment. The score could range from 17 to 102, with higher scores implied greater self-perceived parental competence.
    Time Frame
    through study completion, an average of 4 months
    Title
    The parent's self-perceived stress within the family system
    Description
    Measured by the Parenting Stress Index - Short Form in the RCT experiment. The score could range from 35 to 175, with higher scores implied greater self-perceived stress within the family system
    Time Frame
    up to 25 weeks
    Title
    The parent's self-perceived life quality within the last two weeks
    Description
    Measured by the WHOQOL-BREF - Taiwan version in the RCT experiment. The score could range from 4 to 20 in each domain, with higher scores implied greater self-perceived life quality within the last two weeks
    Time Frame
    up to 25 weeks
    Title
    The child's social communication ability
    Description
    Measured by the self-developed measurement - the Social Communication Rating Scale for young children in the RCT experiment. The score could range from 0 to 38, with higher scores implied greater social communication ability
    Time Frame
    up to 25 weeks
    Title
    The parent's parent-child interaction strategy utilization
    Description
    Measured by the self-developed measurement - the Parental Parent-Child Interaction Strategy Rating Scale in the RCT experiment. The score could range from 20 to 80, with higher scores implied greater parent-child interaction strategy utilization.
    Time Frame
    up to 25 weeks
    Title
    The performance and satisfaction with the child's daily participation
    Description
    Measured by the Canadian Occupational Performance Measure in the single subject experiment. The score could range from 1 to 10, with higher scores implied greater performance or higher satisfaction with the child's daily participation.
    Time Frame
    through study completion, an average of 4 months
    Other Pre-specified Outcome Measures:
    Title
    The parent's satisfaction with the online intervention
    Description
    Measured by self-developed questionnaire used to assess parental parent's satisfaction with the online intervention in the RCT experiment. The score could range from 17 to 68, with higher scores implied higher satisfaction with the online intervention.
    Time Frame
    1 week
    Title
    The parent's satisfaction with the online intervention
    Description
    Measured by self-developed questionnaire used to assess parental parent's satisfaction with the online intervention in the single subject experiment. The score could range from 17 to 68, with higher scores implied higher satisfaction with the online intervention.
    Time Frame
    1 week
    Title
    The coach's satisfaction with the online intervention
    Description
    Measured by self-developed questionnaire used to assess the coach's satisfaction with the online intervention in the RCT experiment. The score could range from 11 to 44, with higher scores implied higher satisfaction with the online intervention.
    Time Frame
    1 week
    Title
    The coach's satisfaction with the online intervention
    Description
    Measured by self-developed questionnaire used to assess the coach's satisfaction with the online intervention in the single subject experiment. The score could range from 11 to 44, with higher scores implied higher satisfaction with the online intervention.
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The child is 3 to 5 years old The child is diagnosed with ASD by a child psychiatrist or specialist in psychology based on the DSM-5's diagnostic criteria The child's score falls within the category of dysfunction in one or more sensory processing functions in the Sensory Profile (3-10 years old version) Exclusion Criteria: Children diagnosed with major neuromuscular dysfunction or other disease diagnoses, such as epilepsy or other genetic diseases Children whose parents could not speak Hokkenese or Chinese and read in Chinese Individuals who have participated in the first year of this study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mei-Hui Tseng, phD
    Phone
    886 2-3366-8175
    Email
    mhtseng@ntu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mei-Hui Tseng, phD
    Organizational Affiliation
    National Taiwan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Telehealth Parent Coaching to Improve Activity Participation for Young Children With ASD and SPD

    We'll reach out to this number within 24 hrs