Clinical trial NCT05827952: The Effect of Self-efficacy and Relationship Through Behavior Modification by Hybrid Mode
Official title: The Effect of Self-efficacy and Relationship Through Behavior Modification by Hybrid Mode in Caregivers With Toddler Receiving Early Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregivers With Toddler Receiving Early Intervention
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intervention Fidelity
timeFrame: through study completion, an average of 8 weeks
measure: Parenting Sense of Confidence
timeFrame: Change from Baseline Parenting Sense of Confidence at 8 weeks
Secondary outcomes:
measure: Parenting Stress Index: Short form
timeFrame: Change from Parenting Stress at 8 weeks
measure: The Conflict Tactics Scales: Parent Version
timeFrame: Change from Conflict Tactics Scales at 8 weeks
measure: Satisfaction Questionnaire:
timeFrame: through study completion, an average of 8 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: FenLing Kuo, Master
role: PRINCIPAL_INVESTIGATOR
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