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

Not Applicable

Recruiting

• Conditions: Caregivers With Toddler Receiving Early Intervention
• Interventions: Behavioral: behavior modification-Atomic Habit by hybrid

• Registration Number: NCT05827952
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-25
• Status Verified: 2024-01
• Study Start: 2024-04-01
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventions	behavior modification-Atomic Habit by hybrid	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.

Primary Outcome Measures

Name	Time	Method
Intervention Fidelity	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	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 Outcome Measures

Name	Time	Method
The Conflict Tactics Scales: Parent Version	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".
Parenting Stress Index: Short form	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.
Satisfaction Questionnaire:	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.

Trial Locations

Locations (1)

Taipei Medical University Shuang Ho Hospital; 🇨🇳 New Taipei City, Taiwan