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

NCT ID: NCT05827952

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Caregivers With Toddler Receiving Early Intervention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

behavior modification-Atomic Habit by hybrid

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

FenLing Kuo, Master

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Shuang Ho Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 34262367 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30997518 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34525940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35613001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32377905 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28929582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30623850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29316336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34925094 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29150738 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35401276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34599167 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31072108 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35947034 (View on PubMed)

Wainer AL, Arnold ZE, Leonczyk C, Valluripalli Soorya L. Examining a stepped-care telehealth program for parents of young children with autism: a proof-of-concept trial. Mol Autism. 2021 May 8;12(1):32. doi: 10.1186/s13229-021-00443-9.

Reference Type BACKGROUND
PMID: 33964979 (View on PubMed)

Salomone E, Pacione L, Shire S, Brown FL, Reichow B, Servili C. Development of the WHO Caregiver Skills Training Program for Developmental Disorders or Delays. Front Psychiatry. 2019 Nov 11;10:769. doi: 10.3389/fpsyt.2019.00769. eCollection 2019.

Reference Type BACKGROUND
PMID: 31780960 (View on PubMed)

Salisbury MR, Roos LE, Horn SR, Peake SJ, Fisher PA. The Effectiveness of KEEP for Families of Children with Developmental Delays: Integrating FIND Video Coaching into Parent Management Training-Oregon Model: a Randomized Trial. Prev Sci. 2022 Aug;23(6):1029-1040. doi: 10.1007/s11121-022-01344-w. Epub 2022 Feb 2.

Reference Type BACKGROUND
PMID: 35107694 (View on PubMed)

Sadeghi S, Pouretemad HR, Shalani B. Internet-based versus face-to-face intervention training for parents of young children with excessive screen-time and autism spectrum disorder-like symptoms: a comparative study. Int J Dev Disabil. 2021 Mar 8;68(5):744-755. doi: 10.1080/20473869.2021.1895699. eCollection 2022.

Reference Type BACKGROUND
PMID: 36210895 (View on PubMed)

Ngai FW, Wong PW, Chung KF, Leung KY, Tarrant M. Randomized controlled trial of telephone-based cognitive-behavioral therapy on parenting self-efficacy and satisfaction. Transl Behav Med. 2019 Nov 25;9(6):1163-1168. doi: 10.1093/tbm/ibz017.

Reference Type BACKGROUND
PMID: 30799485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31191735 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TMU-JIRB N202212060

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.