ParentingLValanNCT05256407
Digital Support for Parents of Children in Child Health Care
A study testing Intervention, digital support in people with Parenting and Children, Only, run by Umeå University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parenting, Children, Only, Health Care Seeking Behavior
- What is being tested?
- Intervention, digital support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2021to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Swedish speaking parents with children (0-6 years) in Swedish child health care
Who cannot join
- Parents who are registered at an address other than their child
- Parents younger than 16 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Support for Parents of Children in Child Health Care - an Evaluation of an Intervention in Primary Health Care
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.
- Conditions
- Parenting, Children, Only, Health Care Seeking Behavior, Health Knowledge, Attitudes, Practice, Nurse-Patient Relations
- Being tested
- Intervention, digital support
- Medical subject headings
- Patient Acceptance of Health Care, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention, digital supportOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention, digital support | Experimental | Parents are offered participation in a digital channel consisting of video consultations, parental support gruops and parental education. Receives: Other: Intervention, digital support |
| Control, usual care | No intervention | Usual child health care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Parental stress at baseline
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.
Measured: Change Parental stress at 4 months
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.
Measured: Change Parental stress at 8 months
Secondary outcomes (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.
Measured: eHealth literacy at baseline
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.
Measured: Increased eHealth literacy at 4 months
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.
Measured: Increased eHealth literacy at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective case/control intervention study
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Västernorrland County Council, Sweden
- Responsible party
- Principal investigator, Asa Hornsten, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256407
- Sponsor's protocol ID
- UmU-2021-LValan
- Acronym
- LValan
- Status last verified
- Feb 2022
- First submitted
- 16 Sep 2021
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Support for Parents of Children in Child Health Care - an Evaluation of an Intervention in Primary Health Care
- ClinicalTrials.gov ID
- NCT05256407
- Acronym / sponsor ID
- LValan / UmU-2021-LValan
- Conditions
- Parenting, Children, Only, Health Care Seeking Behavior, Health Knowledge, Attitudes, Practice, Nurse-Patient Relations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Västernorrland County Council, Sweden
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective case/control intervention study
| Arm | Type | Receives |
|---|---|---|
| Intervention, digital support | Experimental | Other: Intervention, digital supportParents are offered participation in a digital channel consisting of video consultations, parental support gruops and parental education. |
| Control, usual care | No intervention | –Usual child health care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Swedish speaking parents with children (0-6 years) in Swedish child health care
Key exclusion criteria (2 listed)
- Parents who are registered at an address other than their child
- Parents younger than 16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention, digital supportInternet based support of parents in child health care. Various options and choices includes parental education, digital meetings with child health nurse and peer groups | Other | Intervention, digital support |
Primary outcome
Parental Stress Scale
Time frame: Parental stress at baseline
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 Scale
Time frame: Change Parental stress at 4 months
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 Scale
Time frame: Change Parental stress at 8 months
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.
3 secondary outcomes
eHealth Scale
Time frame: eHealth literacy at baseline
eHealth Scale
Time frame: Increased eHealth literacy at 4 months
eHealth Scale
Time frame: Increased eHealth literacy at 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention, digital support in people with Parenting and Children, Only, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lotha Valan, Licentiate (+46703248243, lotha.valan@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Stress Scale (time frame: Parental stress at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.