Digital Support for Parents of Children in Child Health Care

Parenting Clinical Trial

— LValan  

Official title:

Digital Support for Parents of Children in Child Health Care - an Evaluation of an Intervention in Primary Health Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05256407
• Other study ID #: UmU-2021-LValan
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2022
• Source: Umeå University
• Contact: Lotha Valan, Licentiate
• Phone: +46703248243
• Email: lotha.valan[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Becoming a parent is a life-changing event that can be both gratifying and stressful. As a parent, one is responsible for another person, where there sometimes is a need for new information, knowledge, and advice to live up to the new requirements that a changing family situation requires. The objective of this study is to develop and evaluate a new digital channel in child health care for support of parents in child health care issues with particular focus on eHealth literacy and satisfaction with care. An intervention is planned to run over eight months and will be evaluated in an intervention- and control group (from another health care centre) at baseline, 4 months and at 8 months follow-up. Data includes interviews and questionnaires about parental stress and eHealth literacy as well as satisfaction with care. Data will be analysed with qualitative and statistical methods. Expected outcomes is reduced parental stress and increased satisfaction with child health care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Swedish speaking parents with children (0-6 years) in Swedish child health care

Exclusion Criteria:

• Parents who are registered at an address other than their child

• Parents younger than 16 years

Related Conditions & MeSH terms

• Children, Only
• Health Care Seeking Behavior
• Health Knowledge, Attitudes, Practice
• Nurse-Patient Relations
• Parenting

Intervention

Other:
• Intervention, digital support
Internet based support of parents in child health care. Various options and choices includes parental education, digital meetings with child health nurse and peer groups

Locations

Country	Name	City	State
Sweden	Region Västernorrland	Örnsköldsvik

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Västernorrland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VAS Scale	The VAS scale consists of a line with a cross marker where participants can make crosses according to a 5 degree scale in 3 different questions. The line is divided into 5 points with 1 cm distance where marking 1 from the left is graded "not at all" to the last on the right side of the line is 5 "Completely". Total scores of the VAS are summed to range from 3 to 15, with higher scores representing higher levels of degrees.	Satisfaction with child health care at baseline
Other	VAS Scale	The VAS scale consists of a line with a cross marker where participants can make crosses according to a 5 degree scale. The line is divided into 5 points with 1 cm distance where marking 1 from the left is graded "not at all" to the last on the right side of the line is "Completely". Total scores of the VAS are summed to range from 3 to 15, with higher scores representing higher levels of degrees.	Satisfaction with child health care at 4 months
Other	VAS Scale	The VAS scale consists of a line with a cross marker where participants can make crosses according to a 5 degree scale. The line is divided into 5 points with 1 cm distance where marking 1 from the left is graded "not at all" to the last on the right side of the line is "Completely". Total scores of the VAS are summed to range from 3 to 15, with higher scores representing higher levels of degrees.	Satisfaction with child health care at 8 months
Primary	Parental Stress Scale	The scale consists of 17 questions graded from 1 to 5, where 1 indicates "Do not agree at all" and 5 is "Agree completely". A total is calculated by adding all items together to obtain a score ranging from 18 to 90, with higher scores indicating higher levels of parental stress.	Parental stress at baseline
Primary	Parental Stress Scale	The scale consists of 17 questions graded from 1 to 5, where 1 indicates "Do not agree at all" and 5 is "Agree completely". A total is calculated by adding all items together to obtain a score ranging from 18 to 90, with higher scores indicating higher levels of parental stress.	Change Parental stress at 4 months
Primary	Parental Stress Scale	The scale consists of 17 questions graded from 1 to 5, where 1 indicates "Do not agree at all" and 5 is "Agree completely". A total is calculated by adding all items together to obtain a score ranging from 18 to 90, with higher scores indicating higher levels of parental stress.	Change Parental stress at 8 months
Secondary	eHealth Scale	The eHeals scale consists of 10 questions in five ratings where 1 is "do not agree at all" and 5 "fully agree". Total scores of the eHEALS are summed to range from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.	eHealth literacy at baseline
Secondary	eHealth Scale	The eHeals scale consists of 10 questions in five ratings where 1 is "do not agree at all" and 5 "fully agree". Total scores of the eHEALS are summed to range from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.	Increased eHealth literacy at 4 months
Secondary	eHealth Scale	The eHeals scale consists of 10 questions in five ratings where 1 is "do not agree at all" and 5 "fully agree". Total scores of the eHEALS are summed to range from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.	Increased eHealth literacy at 8 months