CClinicalTrials.gg
Status unknownNCT05256407LValanUpdated Feb 25, 2022

Digital Support for Parents of Children in Child Health Care

An interventional study of Intervention, digital support in Parenting, Children, Only and Health Care Seeking Behavior, sponsored by Umeå University. Status unknown at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2022-02-25.

Sponsored by Umeå University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Parenting
  • Children, Only
  • Health Care Seeking Behavior
  • Health Knowledge, Attitudes, Practice
  • Nurse-Patient Relations
03

In context

Lead sponsor

Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Parents who are registered at an address other than their child
  • Parents younger than 16 years
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Intervention, digital support

    Parents are offered participation in a digital channel consisting of video consultations, parental support gruops and parental education.

    Other: Intervention, digital support

  • No intervention
    Control, usual care

    Usual child health care.

Interventions

  • OtherIntervention, 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Parental stress at baseline

  2. 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.

    Time frame: Change Parental stress at 4 months

  3. 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.

    Time frame: Change Parental stress at 8 months

Secondary outcomes

  1. 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.

    Time frame: eHealth literacy at baseline

  2. 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.

    Time frame: Increased eHealth literacy at 4 months

  3. 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.

    Time frame: Increased eHealth literacy at 8 months

Other outcomes

  1. 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.

    Time frame: Satisfaction with child health care at baseline

  2. 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.

    Time frame: Satisfaction with child health care at 4 months

  3. 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.

    Time frame: Satisfaction with child health care at 8 months

07

Study locations

1 of 1 sites recruiting
  • Region Västernorrland
    Örnsköldsvik, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05256407
Lead sponsor
Umeå University
Collaborators
Västernorrland County Council, Sweden
Responsible party
Asa Hornsten (Professor, Umeå University) — Principal investigator
First posted
Feb 25, 2022
Start date
Dec 1, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
May 31, 2023 (estimated)
Last update
Feb 25, 2022

Study contacts

Lotha Valan, Licentiate
Contact
lotha.valan@umu.se
+46703248243
Åsa Hörnsten, Professor
Contact
asa.hornsten@umu.se
+46702494636

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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