Clinical trial NCT05503394: A Peer Support Network System Construction for the Primary Caregivers of Children With Biliary Atresia
Official title: A Peer Support Network System Construction for the Primary Caregivers of Children With Biliary Atresia Based on Social Support Theory: A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Atresia Congenital Type 3
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The peer support WeChat platform for primary caregivers of children with biliary atresia can provide social support ,help them adopt positive coping styles to face the disease, and reduce negative emotions and caregiver burden.

Detailed description: The primary caregivers of children with biliary atresia have a heavy psychological burden, but there is a lack of supportive research on this population. Therefore, this study used a web-based peer support platform to intervene in the primary caregivers of children with biliary atresia to reduce the psychological burden of this population.

The study consisted of two parts. First, a literature analysis, semi-structured interviews, and expert validation are used to form a peer support WeChat platform for primary caregivers of children with biliary atresia.

Second, primary caregivers of children with biliary atresia are selected as the study population and divided into intervention and control groups in chronological order at a children's hospital in Shanghai. Primary caregivers who visit the hospital between August 2022 and October 2022 are assigned to the control group and primary caregivers who visit the hospital between January 2023 and March 2023 are assigned to the intervention group. The intervention group receives a peer support WeChat platform intervention on top of usual care from the day of surgery to one postoperative month. The levels of negative emotions and caregiver burden are compared between the two groups after the intervention.

Eligibility criteria: Inclusion Criteria:

* Child was diagnosed with biliary atresia congenital type 3 and required kasai portoenterostomy ;
* Providing primary care for the child;
* Use a smartphone and have access to the internet;
* Normal communication ability;
* Volunteering to participate in the study.

Exclusion Criteria:

* Existing or previous mental illness;
* Presence of severe anxiety (SAS ≥ 70 points) or depressive mood (SDS ≥ 70 points);
* Children with comorbidities other than biliary atresia;
* Refusal to cooperate.

Primary outcomes:
measure: The depression scores in primary caregivers
timeFrame: At the one month after the surgical kasai portoenterostomy
Secondary outcomes:
measure: The anxiety scores in primary caregivers
timeFrame: At the one month after the surgical kasai portoenterostomy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan University
state: Shanghai
Study officials:
References: