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Completed

NCT Number: NCT05827952

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

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.

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Key information

Conditions

Caregivers With Toddler Receiving Early Intervention

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Shuang Ho Hospital

New Taipei City, 235, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

behavior modification-Atomic Habit by hybrid

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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".

  3. 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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 25, 2023
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.