Autism Spectrum DisorderNCT05871931
The Effect of Tidal Model-Based Psychiatric Nursing Approach on Mothers of Children With Autism Spectrum Disorder
A study testing Tidal Model-based psychiatric nursing approach in people with Autism Spectrum Disorder, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to examine the effect of Tidal Model-based psychiatric nursing approach on internalized stigma and psychological well-being in mothers of children diagnosed with ASD. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Tidal Model-based psychiatric nursing approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2023to 12 Dec 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a child diagnosed with ASD who is studying at Karaköprü Special Education and Practice School in Şanlıurfa.
- Those who agree to participate in the research
- No previous diagnosis of mental illness
- 18 years of age or older
- Knowing how to read and write
- The mother who does not have problems in terms of hearing, speaking and understanding that will prevent communication in the interviews.
Who cannot join
- Under 18 years of age
- Those who have problems in hearing, speaking and understanding that will prevent communication in the interviews
- Mother with any previous diagnosis of mental illness
- Having previously undergone similar intervention
- Having a child with multiple disabilities.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaköprü Special Education Practice I. Level School
Sanliurfa, Karaköprü, 63320
About this study
Official title: The Effect of Tidal Model Based Psychiatric Nursing Approach Applied to Mothers of Children Diagnosed With Autism Spectrum Disorder on Internalized Stigma and Psychological Well-Being
The goal of this clinical trial is to examine the effect of Tidal Model-based psychiatric nursing approach on internalized stigma and psychological well-being in mothers of children diagnosed with ASD.
Read the detailed description
The research will be conducted using a mixed research method that combines qualitative and quantitative research methods. The quantitative part of the research will be conducted using a pre-test-post-test randomised controlled experimental research design, while the qualitative part will be conducted using a phenomenological design.
The study will be conducted with 34 mothers (intervention group = 17, control group = 17) who have children diagnosed with ASD. The intervention group will receive an eight-session Tidal Model-based psychiatric nursing approach. The sessions are planned to take place once a week over an 8-week period. All sessions will be conducted face-to-face. The first and eighth sessions are expected to last an average of 45-50 minutes, while the other sessions are expected to last an average of 70-75 minutes. Personal safety plans, holistic evaluation form , and records of one-on-one sessions will be kept for all sessions conducted. No intervention will be applied to the mothers in the control group. Posttests will be administered to mothers in the intervention group after the eighth interview. Data from the control group will be collected simultaneously with the intervention group. Qualitative data were collected with the metaphor question in the personal information form. The mothers were asked to say "My life story with my child with autism spectrum disorder is like ............. Because ................."" sentence was asked to complete.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Tidal Model-based psychiatric nursing approach
- Keywords
- autism spectrum disorder, Tidal Model, internalized stigma, psychological well-being, Psychiatric nursing
- Medical subject headings
- Autism Spectrum Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal Model-based psychiatric nursing approachOther
The intervention group will receive an eight-session Tidal Model-based psychiatric nursing approach. The sessions will take place once a week over an 8-week period. All sessions will be conducted face-to-face.
The content of the interview plan, consisting of a total of 8 interviews, is as follows:
The first interview was 'Meeting and Pretesting', the second interview was 'Creating a Personal Safety Plan, Making a Holistic Assessment', the third interview was 'Recognizing Emotions, Emotion Management and Communication Skills', the fourth interview was 'Coping Skills', and the fifth interview was 'Self Perception', The sixth interview consisted of 'Strengthening Socialisation', the seventh interview consisted of 'Planning for the Future' and the eighth interview consisted of 'Defining the achievements that will accompany him/her in the next voyages of exploration, ending the relationship between the captain and the lifeguard and making a process evaluation'.
| Study group | Role | What they receive |
|---|---|---|
| Tidal Model-based Psychiatric Nursing | Experimental | The intervention group will receive an eight-session Tidal Model-based psychiatric nursing approach. The sessions are planned to take place once a week over an 8-week period. All sessions will be conducted face-to-face. Receives: Other: Tidal Model-based psychiatric nursing approach |
| No Intervention: Control Group | No intervention | No intervention will be applied to the mothers in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents Internalized Stigma of Mental Illness Scale (PISMI)
The Internalized Stigma of Mental Illnesses Scale (ISMI) was developed by Boyd-Ritsher et al. (2003), and adapted into Turkish by Ersoy and Varan (2007). Then, by Dikeç et al. (2019) based on ISMI, the scale items were adapted to the parents of individuals with mental illness, and Turkish validity reliability was established. The scale consists of 29 items. The scale includes "alienation (item: 1,5,8,16,17,21)", "confirmation of stereotypes (item: 26,10,18,19,23,29)", "perceived discrimination (item: 3.15)". ,22,25,28)", "social withdrawal (item: 4,9,11,12,13,20)", "resistance to stigma (item: 7,14,24,26,27)" It has five subscales. The items in the scale are answered as "strongly disagree" (1 point), "disagree" (2 points), "agree" (3 points), "strongly agree" (4 points). The scale total score ranges from 29 to 116 and there is no scale cutoff score. A high score from the scale indicates that the internalized stigma of the person is more severe in the negative direction.
Measured: Basseline and 8 weeks
Secondary outcomes (1)
Psychological Well-Being Scale (PWS)
The scale was developed by Diener et al. (2009-2010) and adapted into Turkish by Telef (2013). The scale, which consists of eight items in total, has a seven-point Likert structure (1=Strongly disagree, 2=Disagree, 3=Somewhat disagree, 4=Undecided, 5=Disagree a little, 6=Agree, 7=Strongly agree). All items in the scale are expressed positively and the scale has no sub-dimensions. The lowest score obtained from the scale is 8, and the highest score is 56. The total score obtained from the scale is determined by adding the values given to all the items in the scale. A high score from the scale indicates that the person has a high level of psychological well-being.
Measured: Basseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start5 May 2023
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahide Gül YAZGI DEMİR, Mersin University
- Investigators
- Zahide Gül YAZGI DEMİR, PhD Candidate, Principal investigator, Harran University Vocational School of Health ServicesMualla YILMAZ, Professor, Study director, Mersin University, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871931
- Sponsor's protocol ID
- MERSINU-ZYD-01
- Status last verified
- Sep 2025
- First submitted
- 9 May 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tidal Model Based Psychiatric Nursing Approach Applied to Mothers of Children Diagnosed With Autism Spectrum Disorder on Internalized Stigma and Psychological Well-Being
- ClinicalTrials.gov ID
- NCT05871931
- Acronym / sponsor ID
- MERSINU-ZYD-01
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorder, Tidal Model, internalized stigma, psychological well-being, Psychiatric nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 23 May 2023 (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.
The goal of this clinical trial is to examine the effect of Tidal Model-based psychiatric nursing approach on internalized stigma and psychological well-being in mothers of children diagnosed with ASD.
Detailed description
The research will be conducted using a mixed research method that combines qualitative and quantitative research methods. The quantitative part of the research will be conducted using a pre-test-post-test randomised controlled experimental research design, while the qualitative part will be conducted using a phenomenological design.
The study will be conducted with 34 mothers (intervention group = 17, control group = 17) who have children diagnosed with ASD. The intervention group will receive an eight-session Tidal Model-based psychiatric nursing approach. The sessions are planned to take place once a week over an 8-week period. All sessions will be conducted face-to-face. The first and eighth sessions are expected to last an average of 45-50 minutes, while the other sessions are expected to last an average of 70-75 minutes. Personal safety plans, holistic evaluation form , and records of one-on-one sessions will be kept for all sessions conducted. No intervention will be applied to the mothers in the control group. Posttests will be administered to mothers in the intervention group after the eighth interview. Data from the control group will be collected simultaneously with the intervention group. Qualitative data were collected with the metaphor question in the personal information form. The mothers were asked to say "My life story with my child with autism spectrum disorder is like ............. Because ................."" sentence was asked to complete.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tidal Model-based Psychiatric Nursing | Experimental | Other: Tidal Model-based psychiatric nursing approachThe intervention group will receive an eight-session Tidal Model-based psychiatric nursing approach. The sessions are planned to take place once a week over an 8-week period. All sessions will be conducted face-to-face. |
| No Intervention: Control Group | No intervention | –No intervention will be applied to the mothers in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having a child diagnosed with ASD who is studying at Karaköprü Special Education and Practice School in Şanlıurfa.
- Those who agree to participate in the research
- No previous diagnosis of mental illness
- 18 years of age or older
- Knowing how to read and write
Key exclusion criteria (5 listed)
- Under 18 years of age
- Those who have problems in hearing, speaking and understanding that will prevent communication in the interviews
- Mother with any previous diagnosis of mental illness
- Having previously undergone similar intervention
- Having a child with multiple disabilities.
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 |
|---|---|---|
| Tidal Model-based psychiatric nursing approachThe intervention group will receive an eight-session Tidal Model-based psychiatric nursing approach. The sessions will take place once a week over an 8-week period. All sessions will be conducted face-to-face. The content of the interview plan, consisting of a total of 8 interviews, is as follows: The first interview was 'Meeting and Pretesting', the second interview was 'Creating a Personal Safety Plan, Making a Holistic Assessment', the third interview was 'Recognizing Emotions, Emotion Management and Communication Skills', the fourth interview was 'Coping Skills', and the fifth interview was 'Self Perception', The sixth interview consisted of 'Strengthening Socialisation', the seventh interview consisted of 'Planning for the Future' and the eighth interview consisted of 'Defining the achievements that will accompany him/her in the next voyages of exploration, ending the relationship between the captain and the lifeguard and making a process evaluation'. | Other | Tidal Model-based Psychiatric Nursing |
Primary outcome
Parents Internalized Stigma of Mental Illness Scale (PISMI)
Time frame: Basseline and 8 weeks
The Internalized Stigma of Mental Illnesses Scale (ISMI) was developed by Boyd-Ritsher et al. (2003), and adapted into Turkish by Ersoy and Varan (2007). Then, by Dikeç et al. (2019) based on ISMI, the scale items were adapted to the parents of individuals with mental illness, and Turkish validity reliability was established. The scale consists of 29 items. The scale includes "alienation (item: 1,5,8,16,17,21)", "confirmation of stereotypes (item: 26,10,18,19,23,29)", "perceived discrimination (item: 3.15)". ,22,25,28)", "social withdrawal (item: 4,9,11,12,13,20)", "resistance to stigma (item: 7,14,24,26,27)" It has five subscales. The items in the scale are answered as "strongly disagree" (1 point), "disagree" (2 points), "agree" (3 points), "strongly agree" (4 points). The scale total score ranges from 29 to 116 and there is no scale cutoff score. A high score from the scale indicates that the internalized stigma of the person is more severe in the negative direction.
1 secondary outcome
Psychological Well-Being Scale (PWS)
Time frame: Basseline and 8 weeks
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 Sep 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Zahide Gül YAZGI DEMİR, PhD Candidate principal investigator
Harran University Vocational School of Health Services
Mualla YILMAZ, Professor study director
Mersin University, Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tidal Model-based psychiatric nursing approach in people with Autism Spectrum Disorder, run by Mersin 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 6 inclusion and 5 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 Sep 2025. 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?
Parents Internalized Stigma of Mental Illness Scale (PISMI) (time frame: Basseline and 8 weeks). 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 Sep 2025.