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

July 2, 2025 updated by: Taipei Medical University Shuang Ho Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 235
        • Taipei Medical University Shuang Ho Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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..

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Groups/Cohorts
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.
Experimental: Interventions
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.
Behavioral: behavior modification-Atomic Habit by hybrid
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 8 weeks
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.
Change from Baseline Parenting Sense of Confidence at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parenting Stress Index: Short form
Time Frame: Change from Parenting Stress at 8 weeks
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.
Change from Parenting Stress at 8 weeks
The Conflict Tactics Scales: Parent Version
Time Frame: Change from Conflict Tactics Scales at 8 weeks
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".
Change from Conflict Tactics Scales at 8 weeks
Satisfaction Questionnaire:
Time Frame: through study completion, an average of 8 weeks
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.
through study completion, an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Principal Investigator: FenLing Kuo, Master, Taipei Medical University Shuang Ho Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • TMU-JIRB N202212060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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