- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05871931
The Effect of Tidal Model-Based Psychiatric Nursing Approach on Mothers of Children With Autism Spectrum Disorder
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karaköprü
-
Sanliurfa, Karaköprü, Turkey (Türkiye), 63320
- Karaköprü Special Education Practice I. Level School
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tidal Model-based Psychiatric Nursing
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 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'. |
|
No Intervention: No Intervention: Control Group
No intervention will be applied to the mothers in the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Basseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Well-Being Scale (PWS)
Time Frame: Basseline and 8 weeks
|
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.
|
Basseline and 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zahide Gül YAZGI DEMİR, PhD Candidate, Harran University Vocational School of Health Services
- Study Director: Mualla YILMAZ, Professor, Mersin University, Faculty of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MERSINU-ZYD-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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