MothersSTFacilitationNCT06201208
Self-Transcendence Facilitation Psychoeducational Program Applied to Mothers of Children With Special Needs
A study testing The ST-Facilitation Psychoeducation Program in people with Mothers and Special Needs Children, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mothers, Special Needs Children, Psychoeducation
- What is being tested?
- The ST-Facilitation Psychoeducation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 15 May 2024
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Continuing psychiatric treatment during the period when the study was conducted Involvement in another psychosocial intervention that is likely to influence the research outcome.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University
Antalya, Kumluca, 07350
YELDA KUBLAY, RN, Lecturer, +90 552 014 40 49, yelda_kublay@hotmail.com
Saliha Hallaç, PhD, RN, Assoc. Prof., +90 533 224 10 03, saliha.alkan@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Mothers, Special Needs Children, Psychoeducation, Well-being
- Being tested
- The ST-Facilitation Psychoeducation Program
- Keywords
- well being, self-reflection, insight, mother, special needs children, self-transdence theory, psychoeducation program, psychiatric nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ST-Facilitation Psychoeducation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The ST-Facilitation Psychoeducation Program Group | Experimental | 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. Receives: Behavioral: The ST-Facilitation Psychoeducation Program |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Warwick-Edinburgh Mental Well-Being Scale
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.
Measured: 6 months
Self-Transcendence Scale
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.
Measured: 6 months
Self-reflection and Insight Scale
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion15 Mar 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MothersStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Crossover
- Model description
- This study is a non-randomized experimental study with pre-test, post-test, follow-up and control groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YELDA KUBLAY, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201208
- Sponsor's protocol ID
- 70904504/516
- Acronym
- STFacilitation
- Status last verified
- Dec 2023
- First submitted
- 30 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06201208
- Acronym / sponsor ID
- STFacilitation / 70904504/516
- Conditions
- Mothers, Special Needs Children, Psychoeducation, Well-being
- Keywords
- well being, self-reflection, insight, mother, special needs children, self-transdence theory, psychoeducation program, psychiatric nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 11 Jan 2024 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a non-randomized experimental study with pre-test, post-test, follow-up and control groups.
| Arm | Type | Receives |
|---|---|---|
| The ST-Facilitation Psychoeducation Program Group | Experimental | Behavioral: The ST-Facilitation Psychoeducation ProgramThe 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Continuing psychiatric treatment during the period when the study was conducted Involvement in another psychosocial intervention that is likely to influence the research outcome.
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 |
|---|---|---|
| The ST-Facilitation Psychoeducation ProgramOne 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. | Behavioural | The ST-Facilitation Psychoeducation Program Group |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No. 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.
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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 The ST-Facilitation Psychoeducation Program in people with Mothers and Special Needs Children, run by Akdeniz University 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 1 inclusion and 1 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 11 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YELDA KUBLAY (800-664-4542, yelda_kublay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Warwick-Edinburgh Mental Well-Being Scale (time frame: 6 months). 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 11 Jan 2024.