Caregivers With Toddler Receiving Early InterventionNCT05827952

The Effect of Self-efficacy and Relationship Through Behavior Modification by Hybrid Mode

A study testing behavior modification-Atomic Habit by hybrid in people with Caregivers With Toddler Receiving Early Intervention, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Caregivers With Toddler Receiving Early Intervention
What is being tested?: behavior modification-Atomic Habit by hybrid
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteTaiwan
Study dates: 1 Jan 2024to 31 Jan 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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

children currently receiving care in early care;
caregivers with a need to build parent-child relationships or improve self-efficacy;
those who were able to use the pilot process and complete the homework, completing at least 10/12 training;
those with internet access..

Who cannot join

children currently receiving care in early care;
caregivers with a need to build parent-child relationships or improve self-efficacy;
those who were able to use the pilot process and complete the homework, completing at least 10/12 training;
those with internet access.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Taipei Medical University Shuang Ho Hospital
New Taipei City, 235

Other trials in Taiwan

About this study

Official title: The Effect of Self-efficacy and Relationship Through Behavior Modification by Hybrid Mode in Caregivers With Toddler Receiving Early Intervention

The past literature supports the use of digital media as a medium to provide ongoing interventions for families caring for children with difficulties and the opportunity to intervene directly through caregivers, and to combine the advantages of hybrid physical and online interventions, applying different modes of teaching and interacting, satisfying the need for high frequency supervision and feedback for habit building, responding to difficulties and adjusting settings appropriately and immediately, in addition to providing timely assistance, by In addition to providing timely assistance, by changing parents' behavioral patterns and skills, it can increase the caregiver's level of implementation, thus establishing subtle changes and learning in daily life, promoting the quality of interaction and relationship building, and therefore providing intervention.

The study aims to use the new specific model of behavior modification-"Atomic Habit" as the basis for behavior change intervention, combining parental self-identification and children's play participation to establish good thinking and behavior patterns of caregivers, to increase self-identification and reduce stress, and to improve relationships and reduce conflict.

Read the detailed description

Background: The COVID-19 pandemic had reduced access to early care, education, and life participation for families of children with developmental delay, resulting in deterioration of parental mental health, child deterioration, and parental unemployment. The literature supports that face-to-face or online caregiver-mediated interventions could promote child development, self-efficacy and reduce parental stress. The clinical practice of early care center in our hospital lacked a multi-disciplinary integrated relationship facilitation program for caregivers of children with developmental delay.

Purpose: The purpose of this study is to investigate the effects and examine of the behavior modification by hybrid in Stress, self-efficacy, relationships and conflict for caregivers Method: Caregivers of development delay children were recruited and randomly assigned to "Hybrid group"(n=20), and " Self-learning group" (n=19). After 8-weeks training (Online sessions and individual consultation sessions), the performance was assessed by a blinded assessor. The outcome measures included Intervention Fidelity, Parenting Sense of Confidence, Parenting Stress Index: Short form, The Conflict Tactics Scales: Parent Version, habit schedule record, satisfaction questionnaire.

Date analyzing: Collected data will be analyzed with Mann-Whinney U test, the Wilcoxon Signed Ranked Test, and Spearman correlation analysis by SPSS version 20.0, and alpha level was set at 0.05.

Conditions: Caregivers With Toddler Receiving Early Intervention
Being tested: behavior modification-Atomic Habit by hybrid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

behavior modification-Atomic Habit by hybridBehavioural
Atomic Habits (20-minute audiobook format), a role structure, and a game structure, online schedule reminders more than twice a week, and individual counseling sessions (online and physical) with one to two total interventions. The content of the online schedule reminders consisted of a total of four concepts for each of the four major habits, and a total of 16 sessions of the online audiobook interventions were adapted for the caregivers' relationship-building habits with the children.

Study groups in NCT05827952
Study group	Role	What they receive
Groups/Cohorts	No intervention	The "Self-learning group" was designed to provide a description of the goals of the course and a reading of the Atomic Habits book. In the first session, the goals of the study were explained, the basic abilities of the caregiver and the case, the games, the relationship, the main problems that the caregiver wanted to change, the "Parent Problem Checklist" to help assess the caregiver's direction in identifying their own expectations, and the caregiver's perceived barriers and difficulties. The next 8 weeks of the course are based on the parents' self-study progress, and the study provides an online platform or a paper sheet to keep track of the self-study process and to contact the researcher at any time if there are any unexpected situations or problems. The record sheets were returned at the end of the 8-week period, and the self-study group received a face-to-face consultation at the end of the post-test.
Interventions	Experimental	Hybrid group used Atomic Habits (20-minute audiobook format), a role structure and a game structure, online schedule reminders more than twice a week and individual counseling sessions (online and physical) for one to two total interventions. The online schedule reminders consisted of four major habits, each with four concepts, to adapt the online audiobook interventions to the caregivers' relationship-building habits with the children A total of 16 sessions are delivered. Parents simply receive the course through digital media and complete the online schedule reminder within the course progress, narrowing down the indicators of habit change and achieving behavioral change through multiple executions. Receives: Behavioral: behavior modification-Atomic Habit by hybrid

What is being measured

The primary outcome is the main question the study is designed to answer.

Intervention Fidelity
A 4-point scale was used to understand parents' performance in knowledge, practice, participation, time, and use of resources in the implementation of the curriculum. The scale is "1" for totally disagree, "2" for somewhat agree, "3" for mostly agree, and "4 " indicates full agreement.
Measured: through study completion, an average of 8 weeks
Parenting Sense of Confidence
By assessing parents' confidence and satisfaction with their role as a parent, 17 questions were asked on a 6-point scale ranging from "1" for strong agreement to "6" for strong disagreement, with higher scores indicating higher levels of parental confidence. The higher the score, the higher the parent's confidence. The scale is divided into two components, PSOC-E and PSOC-S, which reflect parental frustration, anxiety, and motivation, respectively, and the latter reflects competence, problem solving, and ability to perform the role of a parent. The Parental Effectiveness Scale (PSOC-E), which measures overall parental effectiveness, has a good internal reliability (Cronbach's alpha) of 0.76, while the Parental Satisfaction Scale (PSOC-S) has a good internal reliability (Cronbach's alpha) of 0.75; and can be used with caregivers of children of all ages.
Measured: Change from Baseline Parenting Sense of Confidence at 8 weeks

Secondary outcomes (3)

Parenting Stress Index: Short form
The internal consistency of each subscale ranged from .856 to .908, and the total scale reached .947, representing a high level of consistency in the content of this scale.
Measured: Change from Parenting Stress at 8 weeks
The Conflict Tactics Scales: Parent Version
The second part of the parent-child relationship was used to assess the parenting strategies used by parents/caregivers when children misbehaved, including "non-aggressive discipline" and "aggressive discipline".
Measured: Change from Conflict Tactics Scales at 8 weeks
Satisfaction Questionnaire:
A 12-question questionnaire was developed based on the course content, using a 4-point scale to collect information on caregivers' acceptance of the course, learning benefits, and to understand how caregivers feel they have changed.
Measured: through study completion, an average of 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202431 Jan 2025

First posted25 Apr 2023
Study start1 Jan 2024
Primary completion31 Dec 2024
Study completion31 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Caregivers With Toddler Receiving Early InterventionStudies of the same condition, open and under way.
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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05827952
Sponsor's protocol ID: TMU-JIRB N202212060
Status last verified: Jun 2025
First submitted: 30 Mar 2023
Last updated: 8 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Neece CL, Chan N, Klein K, Roberts L, Fenning RM. Mindfulness-Based Stress Reduction for Parents of Children with Developmental Delays: Understanding the Experiences of Latino Families. Mindfulness (N Y). 2019 Jun;10(6):1017-1030. doi: 10.1007/s12671-018-1011-3. Epub 2018 Sep 6.
PubMed 31191735
Mohan M, Bajaj G, Deshpande A, Anakkathil Anil M, Bhat JS. Child, Parent, and Play - An Insight into These Dimensions Among Children with and without Receptive Expressive Language Disorder Using Video-Based Analysis. Psychol Res Behav Manag. 2021 Jul 7;14:971-985. doi: 10.2147/PRBM.S306733. eCollection 2021.
PubMed 34262367
Choo YY, Agarwal P, How CH, Yeleswarapu SP. Developmental delay: identification and management at primary care level. Singapore Med J. 2019 Mar;60(3):119-123. doi: 10.11622/smedj.2019025.
PubMed 30997518
Corona LL, Stainbrook JA, Simcoe K, Wagner L, Fowler B, Weitlauf AS, Juarez AP, Warren Z. Utilization of telemedicine to support caregivers of young children with ASD and their Part C service providers: a comparison of intervention outcomes across three models of service delivery. J Neurodev Disord. 2021 Sep 15;13(1):38. doi: 10.1186/s11689-021-09387-w.
PubMed 34525940
Edmondson D, Conroy D, Romero-Canyas R, Tanenbaum M, Czajkowski S. Climate change, behavior change and health: a multidisciplinary, translational and multilevel perspective. Transl Behav Med. 2022 May 25;12(4):503-515. doi: 10.1093/tbm/ibac030.
PubMed 35613001
Hao Y, Franco JH, Sundarrajan M, Chen Y. A Pilot Study Comparing Tele-therapy and In-Person Therapy: Perspectives from Parent-Mediated Intervention for Children with Autism Spectrum Disorders. J Autism Dev Disord. 2021 Jan;51(1):129-143. doi: 10.1007/s10803-020-04439-x.
PubMed 32377905
Hemdi A, Daley D. The Effectiveness of a Psychoeducation Intervention delivered via WhatsApp for mothers of children with Autism Spectrum Disorder (ASD) in the Kingdom of Saudi Arabia: A randomized controlled trial. Child Care Health Dev. 2017 Nov;43(6):933-941. doi: 10.1111/cch.12520. Epub 2017 Sep 20.
PubMed 28929582
Humphries T, Kushalnagar P, Mathur G, Napoli DJ, Rathmann C, Smith S. Support for parents of deaf children: Common questions and informed, evidence-based answers. Int J Pediatr Otorhinolaryngol. 2019 Mar;118:134-142. doi: 10.1016/j.ijporl.2018.12.036. Epub 2018 Dec 29.
PubMed 30623850
Ibanez LV, Kobak K, Swanson A, Wallace L, Warren Z, Stone WL. Enhancing interactions during daily routines: A randomized controlled trial of a web-based tutorial for parents of young children with ASD. Autism Res. 2018 Apr;11(4):667-678. doi: 10.1002/aur.1919. Epub 2018 Jan 7.
PubMed 29316336
Klein CB, Swain DM, Vibert B, Clark-Whitney E, Lemelman AR, Giordano JA, Winter J, Kim SH. Implementation of Video Feedback Within a Community Based Naturalistic Developmental Behavioral Intervention Program for Toddlers With ASD: Pilot Study. Front Psychiatry. 2021 Dec 2;12:763367. doi: 10.3389/fpsyt.2021.763367. eCollection 2021.
PubMed 34925094
Leadbitter K, Aldred C, McConachie H, Le Couteur A, Kapadia D, Charman T, Macdonald W, Salomone E, Emsley R, Green J; PACT Consortium. The Autism Family Experience Questionnaire (AFEQ): An Ecologically-Valid, Parent-Nominated Measure of Family Experience, Quality of Life and Prioritised Outcomes for Early Intervention. J Autism Dev Disord. 2018 Apr;48(4):1052-1062. doi: 10.1007/s10803-017-3350-7.
PubMed 29150738
Li F, Wu D, Ren F, Shen L, Xue M, Yu J, Zhang L, Tang Y, Liu X, Tao M, Zhou L, Jiang L, Xu M, Li F. Effectiveness of Online-Delivered Project ImPACT for Children With ASD and Their Parents: A Pilot Study During the COVID-19 Pandemic. Front Psychiatry. 2022 Mar 24;13:806149. doi: 10.3389/fpsyt.2022.806149. eCollection 2022.
PubMed 35401276
List JA, Pernaudet J, Suskind DL. Shifting parental beliefs about child development to foster parental investments and improve school readiness outcomes. Nat Commun. 2021 Oct 1;12(1):5765. doi: 10.1038/s41467-021-25964-y.
PubMed 34599167
Luo J, Wang MC, Gao Y, Zeng H, Yang W, Chen W, Zhao S, Qi S. Refining the Parenting Stress Index-Short Form (PSI-SF) in Chinese Parents. Assessment. 2021 Mar;28(2):551-566. doi: 10.1177/1073191119847757. Epub 2019 May 9.
PubMed 31072108
Waldman-Levi A, Bundy A, Shai D. Cognition Mediates Playfulness Development in Early Childhood: A Longitudinal Study of Typically Developing Children. Am J Occup Ther. 2022 Sep 1;76(5):7605205020. doi: 10.5014/ajot.2022.049120.
PubMed 35947034

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Self-efficacy and Relationship Through Behavior Modification by Hybrid Mode in Caregivers With Toddler Receiving Early Intervention
ClinicalTrials.gov ID: NCT05827952
Acronym / sponsor ID: TMU-JIRB N202212060
Conditions: Caregivers With Toddler Receiving Early Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
Study start: 1 Jan 2024 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Jan 2025 (actual)
First posted: 25 Apr 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.

Detailed description

Date analyzing: Collected data will be analyzed with Mann-Whinney U test, the Wilcoxon Signed Ranked Test, and Spearman correlation analysis by SPSS version 20.0, and alpha level was set at 0.05.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Groups/Cohorts	No intervention	–The "Self-learning group" was designed to provide a description of the goals of the course and a reading of the Atomic Habits book. In the first session, the goals of the study were explained, the basic abilities of the caregiver and the case, the games, the relationship, the main problems that the caregiver wanted to change, the "Parent Problem Checklist" to help assess the caregiver's direction in identifying their own expectations, and the caregiver's perceived barriers and difficulties. The next 8 weeks of the course are based on the parents' self-study progress, and the study provides an online platform or a paper sheet to keep track of the self-study process and to contact the researcher at any time if there are any unexpected situations or problems. The record sheets were returned at the end of the 8-week period, and the self-study group received a face-to-face consultation at the end of the post-test.
Interventions	Experimental	Behavioral: behavior modification-Atomic Habit by hybridHybrid group used Atomic Habits (20-minute audiobook format), a role structure and a game structure, online schedule reminders more than twice a week and individual counseling sessions (online and physical) for one to two total interventions. The online schedule reminders consisted of four major habits, each with four concepts, to adapt the online audiobook interventions to the caregivers' relationship-building habits with the children A total of 16 sessions are delivered. Parents simply receive the course through digital media and complete the online schedule reminder within the course progress, narrowing down the indicators of habit change and achieving behavioral change through multiple executions.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

children currently receiving care in early care;
caregivers with a need to build parent-child relationships or improve self-efficacy;
those who were able to use the pilot process and complete the homework, completing at least 10/12 training;
those with internet access..

Key exclusion criteria (4 listed)

children currently receiving care in early care;
caregivers with a need to build parent-child relationships or improve self-efficacy;
those who were able to use the pilot process and complete the homework, completing at least 10/12 training;
those with internet access.

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
behavior modification-Atomic Habit by hybridAtomic Habits (20-minute audiobook format), a role structure, and a game structure, online schedule reminders more than twice a week, and individual counseling sessions (online and physical) with one to two total interventions. The content of the online schedule reminders consisted of a total of four concepts for each of the four major habits, and a total of 16 sessions of the online audiobook interventions were adapted for the caregivers' relationship-building habits with the children.	Behavioural	Interventions

Primary outcome

Intervention Fidelity
Time frame: through study completion, an average of 8 weeks
A 4-point scale was used to understand parents' performance in knowledge, practice, participation, time, and use of resources in the implementation of the curriculum. The scale is "1" for totally disagree, "2" for somewhat agree, "3" for mostly agree, and "4 " indicates full agreement.
Parenting Sense of Confidence
Time frame: Change from Baseline Parenting Sense of Confidence at 8 weeks
By assessing parents' confidence and satisfaction with their role as a parent, 17 questions were asked on a 6-point scale ranging from "1" for strong agreement to "6" for strong disagreement, with higher scores indicating higher levels of parental confidence. The higher the score, the higher the parent's confidence. The scale is divided into two components, PSOC-E and PSOC-S, which reflect parental frustration, anxiety, and motivation, respectively, and the latter reflects competence, problem solving, and ability to perform the role of a parent. The Parental Effectiveness Scale (PSOC-E), which measures overall parental effectiveness, has a good internal reliability (Cronbach's alpha) of 0.76, while the Parental Satisfaction Scale (PSOC-S) has a good internal reliability (Cronbach's alpha) of 0.75; and can be used with caregivers of children of all ages.

3 secondary outcomes

Parenting Stress Index: Short form
Time frame: Change from Parenting Stress at 8 weeks
The Conflict Tactics Scales: Parent Version
Time frame: Change from Conflict Tactics Scales at 8 weeks
Satisfaction Questionnaire:
Time frame: through study completion, an average of 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
Background: PubMed 31191735Neece CL, Chan N, Klein K, Roberts L, Fenning RM. Mindfulness-Based Stress Reduction for Parents of Children with Developmental Delays: Understanding the Experiences of Latino Families. Mindfulness (N Y). 2019 Jun;10(6):1017-1030. doi: 10.1007/s12671-018-1011-3. Epub 2018 Sep 6.
Results publication: PubMed 34262367Mohan M, Bajaj G, Deshpande A, Anakkathil Anil M, Bhat JS. Child, Parent, and Play - An Insight into These Dimensions Among Children with and without Receptive Expressive Language Disorder Using Video-Based Analysis. Psychol Res Behav Manag. 2021 Jul 7;14:971-985. doi: 10.2147/PRBM.S306733. eCollection 2021.
Results publication: PubMed 30997518Choo YY, Agarwal P, How CH, Yeleswarapu SP. Developmental delay: identification and management at primary care level. Singapore Med J. 2019 Mar;60(3):119-123. doi: 10.11622/smedj.2019025.
Results publication: PubMed 34525940Corona LL, Stainbrook JA, Simcoe K, Wagner L, Fowler B, Weitlauf AS, Juarez AP, Warren Z. Utilization of telemedicine to support caregivers of young children with ASD and their Part C service providers: a comparison of intervention outcomes across three models of service delivery. J Neurodev Disord. 2021 Sep 15;13(1):38. doi: 10.1186/s11689-021-09387-w.
Results publication: PubMed 35613001Edmondson D, Conroy D, Romero-Canyas R, Tanenbaum M, Czajkowski S. Climate change, behavior change and health: a multidisciplinary, translational and multilevel perspective. Transl Behav Med. 2022 May 25;12(4):503-515. doi: 10.1093/tbm/ibac030.
Results publication: PubMed 32377905Hao Y, Franco JH, Sundarrajan M, Chen Y. A Pilot Study Comparing Tele-therapy and In-Person Therapy: Perspectives from Parent-Mediated Intervention for Children with Autism Spectrum Disorders. J Autism Dev Disord. 2021 Jan;51(1):129-143. doi: 10.1007/s10803-020-04439-x.
Results publication: PubMed 28929582Hemdi A, Daley D. The Effectiveness of a Psychoeducation Intervention delivered via WhatsApp for mothers of children with Autism Spectrum Disorder (ASD) in the Kingdom of Saudi Arabia: A randomized controlled trial. Child Care Health Dev. 2017 Nov;43(6):933-941. doi: 10.1111/cch.12520. Epub 2017 Sep 20.
Results publication: PubMed 30623850Humphries T, Kushalnagar P, Mathur G, Napoli DJ, Rathmann C, Smith S. Support for parents of deaf children: Common questions and informed, evidence-based answers. Int J Pediatr Otorhinolaryngol. 2019 Mar;118:134-142. doi: 10.1016/j.ijporl.2018.12.036. Epub 2018 Dec 29.
Results publication: PubMed 29316336Ibanez LV, Kobak K, Swanson A, Wallace L, Warren Z, Stone WL. Enhancing interactions during daily routines: A randomized controlled trial of a web-based tutorial for parents of young children with ASD. Autism Res. 2018 Apr;11(4):667-678. doi: 10.1002/aur.1919. Epub 2018 Jan 7.
Results publication: PubMed 34925094Klein CB, Swain DM, Vibert B, Clark-Whitney E, Lemelman AR, Giordano JA, Winter J, Kim SH. Implementation of Video Feedback Within a Community Based Naturalistic Developmental Behavioral Intervention Program for Toddlers With ASD: Pilot Study. Front Psychiatry. 2021 Dec 2;12:763367. doi: 10.3389/fpsyt.2021.763367. eCollection 2021.
Results publication: PubMed 29150738Leadbitter K, Aldred C, McConachie H, Le Couteur A, Kapadia D, Charman T, Macdonald W, Salomone E, Emsley R, Green J; PACT Consortium. The Autism Family Experience Questionnaire (AFEQ): An Ecologically-Valid, Parent-Nominated Measure of Family Experience, Quality of Life and Prioritised Outcomes for Early Intervention. J Autism Dev Disord. 2018 Apr;48(4):1052-1062. doi: 10.1007/s10803-017-3350-7.
Results publication: PubMed 35401276Li F, Wu D, Ren F, Shen L, Xue M, Yu J, Zhang L, Tang Y, Liu X, Tao M, Zhou L, Jiang L, Xu M, Li F. Effectiveness of Online-Delivered Project ImPACT for Children With ASD and Their Parents: A Pilot Study During the COVID-19 Pandemic. Front Psychiatry. 2022 Mar 24;13:806149. doi: 10.3389/fpsyt.2022.806149. eCollection 2022.
Individual participant dataSharing planned: No

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.

FenLing Kuo, Master principal investigator

Taipei Medical University Shuang Ho Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention Fidelity (time frame: through study completion, an average of 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05827952, which also lists 21 linked publications.

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 8 Jul 2025.