Self-Transcendence Facilitation Psychoeducational Program Applied to Mothers of Children With Special Needs (STFacilitation)

December 30, 2023 updated by: YELDA KUBLAY, Akdeniz University

The Effect on Well-Being, Self-Transcendence, Self-Reflection and Insight of the Self-Transcendence Facilitation Psychoeducational Program Applied to Mothers of Children With Special Needs

This study aimed to determine the effect of the Facilitating Self-Transcendence Psychoeducation Program, which will be applied to mothers of children with special needs, on well-being, self-transcendence, self-reflection, and insight.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aimed to determine the effect of the Facilitating Self-Transcendence Psychoeducation Program, which will be applied to mothers of children with special needs, on well-being, self-transcendence, self-reflection and insight.

This study is a non-randomized experimental study with pre-test, post-test, follow-up and control groups. A 2x3 split-plot factorial design will be used as the research design. In this design, the first factor shows independent interventional procedure groups, and the second factor shows repeated measurements of the dependent variable (pre-test, post-test and follow-up). Considering the theoretical basis of psychoeducational programs, the follow-up period in this study was planned to be eight weeks after the last session.

The study will be carried out between February 2024 and July 2024. The sample of the study will consist of mothers of children with special needs between the ages of 0-11 who are registered in a special education and rehabilitation center in Kumluca. 30 mothers will be included in the intervention group and 30 mothers in the control group. The ST-Facilitation psychoeducation program is planned for mothers in the intervention group as an 80-minute session (40-minute session + 20-minute break + 40-minute session) once a week for six weeks, in groups of two to four people. Data will be collected using the Personal Information Form, Self-Transcendence Scale, Warwick-Edinburgh Mental Well-Being Scale and Self-reflection and Insight Scale.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Kumluca
      • Antalya, Kumluca, Turkey, 07350
        • Akdeniz University
        • Contact:
        • Contact:
        • Principal Investigator:
          • YELDA KUBLAY, RN, Lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Volunteering to participate in research No cognitive disabilities such as reading, writing, communication and understanding No possibility of leaving the region during the research. Being a mother of a child with special needs between the ages of 0-11

Exclusion Criteria:

Continuing psychiatric treatment during the period when the study was conducted Involvement in another psychosocial intervention that is likely to influence the research outcome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The ST-Facilitation Psychoeducation Program Group
The ST-Facilitation Psychoeducation Program is planned for mothers in the intervention group as an 80-minute session (40-minute session + 20-minute break + 40-minute session) once a week for six weeks, in groups of two to four participants.
Behavioral: The ST-Facilitation Psychoeducation Program

One of the important roles of the psychiatric nurse, who helps healthy/sick individuals and their families to improve their mental health, prevent and cope with diseases, is their educational role. The psychiatric nurse determines the psychosocial care needs of the patient and his family and plans, implements and evaluates psychoeducational interventions, which are an evidence-based practice, to meet these needs.

Psychiatric nurses can benefit from existing programs when developing a psychoeducation program, or they can be advised to create programs that include educational and psychosocial goals based on theory specific to the problems of the relevant population. The theoretical basis is of great importance when planning a psychoeducation program. In this study, the psychoeducation program was based on the Self-Transcendence Theory of Pamela G. Reed, a psychiatric nurse.
No Intervention: Control Group
No action will be taken by the researcher during the research. Only data collection will be carried out. At the end of the research, ST-Facilitation Psychoeducation Program will be applied ethically.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Warwick-Edinburgh Mental Well-Being Scale
Time Frame: 6 months
Warwick-Edinburgh Mental Well-Being Scale consists of 14 items and a single dimension. The scale is five-point Likert type. Scoring of the scale is as follows: 1 = strongly disagree, 2 = disagree, 3 = somewhat agree, 4 = agree, 5 = completely agree. All items of the scale are positive and there is no cut-off score. The minimum score from the scale is 14 and the maximum score is 70. High scores from the scale indicate high mental well-being.
6 months
Self-Transcendence Scale
Time Frame: 6 months
Self-Transcendence Scale is a unidimensional scale consisting of 15 items. The scale is a four-point Likert type. Scoring of the scale is as follows: 1 = not at all, 2 = very little, 3 = quite a bit, 4 = very much. All items of the scale are positive and there is no cut-off score. A minimum of 15 and a maximum of 60 points are obtained from the scale. Increasing scores from the scale are evaluated as increasing self-transcendence.
6 months
Self-reflection and Insight Scale
Time Frame: 6 months
The scale consists of 20 items and two factors. These factors are "self-reflection" and "insight"; The "self-reflection" factor has two sub-dimensions: being dependent on self-reflection and needing self-reflection. There are 8 items in the "insight" factor of the scale and 12 items in the "self-reflection" factor. The scale is a six-point Likert type. Scoring of the scale is 1 = strongly disagree, 2 = disagree, 3 = partially disagree, 4 = partially agree, 5 = agree, 6 = strongly agree. Items that require reverse scoring are items 1, 2, 4, 8, 9, 11, 13, 14 and 17. In reverse scoring, a score of "1" becomes "6"; "2" becomes "5"; "3" becomes "4" and vice versa. No scaling or scale conversion is required other than basic reverse scoring. A minimum of 20 and a maximum of 120 points are obtained from the scale.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 70904504/516

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In order to preserve the originality of the research, it is not intended to be shared until the research is completed and reaches the publication stage.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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