AnxietyNCT04609722
Effect of Solution-Focused Support Program on Anxiety Levels of Parents During the COVID-19 Pandemic
A study testing Solution-Focused Support Program in people with Anxiety and Parents, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this research, it was aimed to determine the anxiety levels of parents in the Covid-19 pandemic and to examine the effects of the Solution-Focused Support Program, which is planned to be given to parents with high anxiety levels. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Solution-Focused Support Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 1 Apr 2021
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Parents with children aged 3-6,
- Having internet at home or mobile phone,
- Parents who volunteer to participate in the study
Who cannot join
- Having communication problems,
- Parents who have not attended at least one session
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Online- Data will be collected through the form created with the Google-Forms
Adıyaman, 02100
About this study
Official title: Effect of Solution-Focused Support Program on Anxiety Levels of Parents With Children Aged 3-6 Years During the COVID-19 Pandemic
In this research, it was aimed to determine the anxiety levels of parents in the Covid-19 pandemic and to examine the effects of the Solution-Focused Support Program, which is planned to be given to parents with high anxiety levels.
Read the detailed description
The study is conducted with parents whose children aged 3-6 years, and have high anxiety levels. In collecting research data; an introductory information form prepared by researchers and the State-Trait Anxiety Inventory will be used.
- Being tested
- Solution-Focused Support Program
- Keywords
- anxiety, child, nursing practice, parents, Solution-Focused Support Program
- Medical subject headings
- Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solution-Focused Support ProgramOther
All participants will be given a program of 4 sessions for 4 weeks. Each session is planned to last approximately 50 minutes.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Solution-Focused Support Program will apply to the participants. Receives: Other: Solution-Focused Support Program |
| control group | No intervention | No intervention will be applied to the parents in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory (STAI)
STAI was developed by Spielberg et al. In 1970 to measure the trait and state anxiety levels of individuals and was adapted to Turkish by Öner and Le Compte (1983) (Gilik and Avşaroğlu 2017). There are a total of 40 questions in the State-Trait Anxiety Scale. The State Anxiety Sub-Scale (STAI-S) evaluates how an individual feels at a particular time and under certain conditions. The Trait Anxiety Subscale (STAI-T) generally assesses how an individual feels. The scores obtained from both scales vary between 20 and 80. High score indicates high anxiety level, low score indicates low anxiety level.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Jul 2020
- Primary completion1 Dec 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mürşide Zengin, Adiyaman University Research Hospital
- Investigators
- Ceyda Başoğul, Principal investigator, Adiyaman UniversityEmriye Hilal Yayan, Principal investigator, Inonu UniversityMürşide Zengin, Principal investigator, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609722
- Sponsor's protocol ID
- 2020/751
- Status last verified
- Feb 2023
- First submitted
- 26 Oct 2020
- Last updated
- 8 Feb 2023
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Solution-Focused Support Program on Anxiety Levels of Parents With Children Aged 3-6 Years During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04609722
- Acronym / sponsor ID
- 2020/751
- Keywords
- anxiety, child, nursing practice, parents, Solution-Focused Support Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 30 Oct 2020 (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.
In this research, it was aimed to determine the anxiety levels of parents in the Covid-19 pandemic and to examine the effects of the Solution-Focused Support Program, which is planned to be given to parents with high anxiety levels.
Detailed description
The study is conducted with parents whose children aged 3-6 years, and have high anxiety levels. In collecting research data; an introductory information form prepared by researchers and the State-Trait Anxiety Inventory will be used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Solution-Focused Support ProgramSolution-Focused Support Program will apply to the participants. |
| control group | No intervention | –No intervention will be applied to the parents in the control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Parents with children aged 3-6,
- Having internet at home or mobile phone,
- Parents who volunteer to participate in the study
Key exclusion criteria (2 listed)
- Having communication problems,
- Parents who have not attended at least one session
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 |
|---|---|---|
| Solution-Focused Support ProgramAll participants will be given a program of 4 sessions for 4 weeks. Each session is planned to last approximately 50 minutes. | Other | intervention group |
Primary outcome
State-Trait Anxiety Inventory (STAI)
Time frame: 5 minutes
STAI was developed by Spielberg et al. In 1970 to measure the trait and state anxiety levels of individuals and was adapted to Turkish by Öner and Le Compte (1983) (Gilik and Avşaroğlu 2017). There are a total of 40 questions in the State-Trait Anxiety Scale. The State Anxiety Sub-Scale (STAI-S) evaluates how an individual feels at a particular time and under certain conditions. The Trait Anxiety Subscale (STAI-T) generally assesses how an individual feels. The scores obtained from both scales vary between 20 and 80. High score indicates high anxiety level, low score indicates low anxiety level.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- 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.
Ceyda Başoğul principal investigator
Adiyaman University
Emriye Hilal Yayan principal investigator
Inonu University
Mürşide Zengin principal investigator
Adiyaman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solution-Focused Support Program in people with Anxiety and Parents, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 8 Feb 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (STAI) (time frame: 5 minutes). 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 8 Feb 2023.