NCT05871931

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

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

May 5, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2023

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

May 9, 2023

Last Update Submit

September 2, 2025

Conditions

Keywords

autism spectrum disorderTidal Modelinternalized stigmapsychological well-beingPsychiatric nursing

Outcome Measures

Primary Outcomes (1)

  • 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.

    Basseline and 8 weeks

Secondary Outcomes (1)

  • Psychological Well-Being Scale (PWS)

    Basseline and 8 weeks

Study Arms (2)

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.

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.

Interventions

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'.

Tidal Model-based Psychiatric Nursing

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaköprü Special Education Practice I. Level School

Sanliurfa, Karaköprü, 63320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum DisorderPsychological Well-Being

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersPersonal SatisfactionBehavior

Study Officials

  • Zahide Gül YAZGI DEMİR, PhD Candidate

    Harran University Vocational School of Health Services

    PRINCIPAL INVESTIGATOR
  • Mualla YILMAZ, Professor

    Mersin University, Faculty of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the study, researcher (ZGYD) and participant blinding cannot be performed because the mothers participating in the study know which group they belong to. Upon completion of the study, the data will be transferred to a computer environment and an independent statistician will analyse the data without knowing which group is the intervention group and which is the control group, and the findings will be reported.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 23, 2023

Study Start

May 5, 2023

Primary Completion

December 12, 2023

Study Completion

December 12, 2023

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations