NCT04609722

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

October 26, 2020

Last Update Submit

February 4, 2023

Conditions

Keywords

anxietychildnursing practiceparentsSolution-Focused Support Program

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 minutes

Study Arms (2)

intervention group

EXPERIMENTAL

Solution-Focused Support Program will apply to the participants.

Other: Solution-Focused Support Program

control group

NO INTERVENTION

No intervention will be applied to the parents in the control group.

Interventions

All participants will be given a program of 4 sessions for 4 weeks. Each session is planned to last approximately 50 minutes.

intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Parents with children aged 3-6,
  • Having internet at home or mobile phone,
  • Parents who volunteer to participate in the study

You may not qualify if:

  • Having communication problems,
  • Parents who have not attended at least one session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Online- Data will be collected through the form created with the Google-Forms

Adıyaman, 02100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersCOVID-19

Condition Hierarchy (Ancestors)

Mental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ceyda Başoğul

    Adiyaman University

    PRINCIPAL INVESTIGATOR
  • Emriye Hilal Yayan

    İnönü University

    PRINCIPAL INVESTIGATOR
  • Mürşide Zengin

    Adiyaman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adıyaman University

Study Record Dates

First Submitted

October 26, 2020

First Posted

October 30, 2020

Study Start

July 1, 2020

Primary Completion

December 1, 2020

Study Completion

April 1, 2021

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations