Sensory Processing DisorderNCT06079632
Telehealth Parent Coaching to Improve Activity Participation for Young Children With ASD and SPD
A study testing parent coaching via telehealth and weekly self-learning materials and group discussion session in people with Sensory Processing Disorder and Autism Spectrum Disorder, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Sensory Processing Disorder, Autism Spectrum Disorder
- What is being tested?
- parent coaching via telehealth and weekly self-learning materials and group discussion session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Telehealth Parent Coaching to Improve Activity Participation for Young Children With Autism Spectrum Disorder and Sensory Processing Disorders: A Prospective Study
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.
- Being tested
- parent coaching via telehealth, weekly self-learning materials and group discussion session
- Keywords
- Sensory Processing Disorder, Parent-mediated intervention, Autism Spectrum Disorder, Parent Coaching via Telehealth
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parent coaching via telehealthBehavioural
Participants receive 12 weeks of parent-child interaction strategy coaching and sensory processing strategy coaching intervention.
weekly self-learning materials and group discussion sessionBehavioural
Participants receive 1-hour self-learning materials, including parent-child interaction and sensory processing strategies, and 1-hour remote group discussion session weekly.
| Study group | Role | What they receive |
|---|---|---|
| Single subject experiment | Experimental | 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. Receives: Behavioral: parent coaching via telehealth |
| RCT, Treatment group | Experimental | Participant receive 12 weeks of sensory processing strategy coaching and parent-child interaction strategy coaching intervention. Receives: Behavioral: parent coaching via telehealth |
| RCT, Active Comparator | Active comparator | Participant will be provided with weekly self-learning materials and group discussion session for 12 weeks. Receives: Behavioral: weekly self-learning materials and group discussion session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 25 weeks
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.
Measured: through study completion, an average of 4 months
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.
Measured: through study completion, an average of 4 months
Secondary outcomes (11)
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.
Measured: up to 25 weeks
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.
Measured: up to 25 weeks
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.
Measured: through study completion, an average of 4 months
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.
Measured: up to 25 weeks
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.
Measured: up to 25 weeks
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.
Measured: through study completion, an average of 4 months
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
Measured: up to 25 weeks
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
Measured: up to 25 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
Measured: up to 25 weeks
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.
Measured: up to 25 weeks
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.
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Processing DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, National Taiwan University
- Responsible party
- Sponsor
- Investigators
- Mei-Hui Tseng, phD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079632
- Sponsor's protocol ID
- 202301189RINA
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Parent Coaching to Improve Activity Participation for Young Children With Autism Spectrum Disorder and Sensory Processing Disorders: A Prospective Study
- ClinicalTrials.gov ID
- NCT06079632
- Acronym / sponsor ID
- 202301189RINA
- Keywords
- Sensory Processing Disorder, Parent-mediated intervention, Autism Spectrum Disorder, Parent Coaching via Telehealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, National Taiwan University
- Study start
- Oct 2023 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single subject experiment | Experimental | Behavioral: parent coaching via telehealthEach 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. |
| RCT, Treatment group | Experimental | Behavioral: parent coaching via telehealthParticipant receive 12 weeks of sensory processing strategy coaching and parent-child interaction strategy coaching intervention. |
| RCT, Active Comparator | Active comparator | Behavioral: weekly self-learning materials and group discussion sessionParticipant will be provided with weekly self-learning materials and group discussion session for 12 weeks. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parent coaching via telehealthParticipants receive 12 weeks of parent-child interaction strategy coaching and sensory processing strategy coaching intervention. | Behavioural | RCT, Treatment group, Single subject experiment |
| weekly self-learning materials and group discussion sessionParticipants receive 1-hour self-learning materials, including parent-child interaction and sensory processing strategies, and 1-hour remote group discussion session weekly. | Behavioural | RCT, Active Comparator |
Primary outcome
The performance and satisfaction with the child's daily participation
Time frame: up to 25 weeks
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
Time frame: through study completion, an average of 4 months
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
Time frame: through study completion, an average of 4 months
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.
11 secondary outcomes
The social functioning and adaptive behavior of the child
Time frame: up to 25 weeks
The attainment of the selected goal related to issues with the child's sensory processing disorder
Time frame: up to 25 weeks
The 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
The child's performance in social communication
Time frame: up to 25 weeks
The parent's self-perceived parental competence
Time frame: up to 25 weeks
The parent's self-perceived parental competence
Time frame: through study completion, an average of 4 months
The parent's self-perceived stress within the family system
Time frame: up to 25 weeks
The parent's self-perceived life quality within the last two weeks
Time frame: up to 25 weeks
The child's social communication ability
Time frame: up to 25 weeks
The parent's parent-child interaction strategy utilization
Time frame: up to 25 weeks
The performance and satisfaction with the child's daily participation
Time frame: through study completion, an average of 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Hui Tseng, phD principal investigator
National Taiwan University
Questions about this trial
What is this clinical trial studying?
A study testing parent coaching via telehealth and weekly self-learning materials and group discussion session in people with Sensory Processing Disorder and Autism Spectrum Disorder, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei-Hui Tseng, phD (886 2-3366-8175, mhtseng@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance and satisfaction with the child's daily participation (time frame: up to 25 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.