DeafIntegrativeNCT07514468
Effectiveness of Integrative Therapy on Psychological Hardiness Among Hard-of-Hearing Female Students
A study testing Integrative Therapeutic Program in people with Deaf and Hard of Hearing, run by King Faisal University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial (quasi-experimental study) is to learn whether an integrative therapeutic program can enhance psychological hardiness among hard-of-hearing (HOH) female students in Saudi Arabia (Al-Ahsa Governorate). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 13 to 19 years, women only
- Conditions the study is for
- Deaf, Hard of Hearing, Hearing Disability
- What is being tested?
- Integrative Therapeutic Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Dec 2025to 2 Mar 2026
- 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 13 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female students with hearing impairment (Hard of Hearing, HOH)
- Enrollment in inclusive schools in Al-Ahsa Governorate, Saudi Arabia
- Within the targeted educational stage of the study
- Low scores on the Psychological Hardiness Scale at (pre-test)
- Ability to participate in and complete the intervention program
- Provision of informed consent
Who cannot join
- Failure to provide informed consent
- Incomplete participation in (pre-test) or post-intervention (post-test) assessments
- Diagnosis of profound deafness that limits effective communication required for the intervention
- Male students (excluded due to logistical and cultural constraints related to intervention delivery)
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Schools for the hearing impaired in Al-Ahsa
Al Mubarraz, 31982
About this study
Official title: The Effectiveness of an Integrative Therapeutic Program in Enhancing Psychological Hardiness Among Hard-of-Hearing Female Students in Saudi Arabia
The goal of this clinical trial (quasi-experimental study) is to learn whether an integrative therapeutic program can enhance psychological hardiness among hard-of-hearing (HOH) female students in Saudi Arabia (Al-Ahsa Governorate). The main questions it aims to answer are:
- What is the level of psychological hardiness among DHH female students in the Kingdom of Saudi Arabia?
- Are there statistically significant differences in the level of psychological hardiness among DHH female students attributable to the study variables (degree of hearing loss, grade level, hearing assistive device, communication method used, parents' hearing status, and type of educational environment attended)?
- Are there statistically significant differences at the level of (α = 0.05) between the mean scores of the experimental group on the psychological hardiness scale in the pre- and post-measurements?
- Are there statistically significant differences at the level of (α = 0.05) between the mean scores of the experimental and control groups on the post-measurement of the psychological hardiness scale?
Read more
Researchers will compare students who participate in the integrative therapeutic program (experimental group) with those who do not (control group) to see if the program leads to improved psychological hardiness.
Participants will:
Complete a psychological hardiness scale before and after the program Participate in the integrative therapeutic training sessions (experimental group only) Continue their regular educational activities without intervention (control group)
Read the detailed description
This study was conducted to evaluate the effectiveness of an integrative therapeutic program in enhancing psychological hardiness among hard-of-hearing (HOH) female students in inclusive educational settings in Al-Ahsa Governorate, Kingdom of Saudi Arabia. HOH students often face multiple psychological and social challenges that may negatively affect their adaptive functioning and overall well-being. Therefore, this study aimed to provide an evidence-based intervention to strengthen psychological resilience and improve coping capacities within this population.
A quasi-experimental design with a non-randomized experimental and control group structure was adopted. The study initially involved a broader sample of 69 deaf and hard-of-hearing (DHH) female students. All participants were assessed using a Psychological Hardiness Scale developed and validated by the researchers. Based on (pre-test) results, a purposive sample of 25 HOH students who demonstrated relatively low levels of psychological hardiness was selected to participate in the intervention phase.
The selected participants were divided into two groups: an experimental group (n = 15), which received the integrative therapeutic program, and a control group (n = 10), which did not receive any intervention during the study period. The intervention program was designed to enhance key dimensions of psychological hardiness, including commitment, control, and challenge, through structured therapeutic activities and training sessions tailored to the communication abilities and learning needs of HOH students.
All participants underwent pre-test and post-test assessments using the same psychological hardiness scale. The primary outcome measure was the change in psychological hardiness scores between pre-test and post-test evaluations. The effectiveness of the intervention was determined by comparing within-group changes (pre- vs. post-test) and between-group differences (experimental vs. control group). The higher the student's score on the scale, the greater the improvement in her level of psychological hardiness.
The independent variable in this study was the integrative therapeutic program, while the dependent variable was psychological hardiness. Although the study design aimed to control for confounding variables, several external factors may have influenced the outcomes, including parental support, teacher preparedness, peer interactions, and the broader educational and social environment.
The findings demonstrated statistically significant improvements in psychological hardiness among participants in the experimental group compared to the control group, indicating the effectiveness of the implemented program. These results support the integration of structured therapeutic interventions within educational support services for HOH students to enhance their psychological well-being and quality of life.
- Conditions
- Deaf, Hard of Hearing, Hearing Disability
- Being tested
- Integrative Therapeutic Program
- Keywords
- Integrative therapeutic program, psychological hardiness, hearing impairment, hard-of-hearing middle school students
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Therapeutic ProgramOther
The therapeutic program was developed based on the integrative therapy approach, which involves combining techniques and strategies derived from multiple therapeutic schools in accordance with the characteristics of the target population, without adhering to a single theoretical framework. The integrative approach draws on contemporary integrative perspectives that emphasize flexibility in intervention according to the needs of beneficiaries. The program was also grounded in the psychological hardiness theory developed by Suzanne Kobasa, which conceptualizes hardiness through three dimensions: commitment, control, and challenge. In addition, the program incorporated techniques drawn from several therapeutic approaches, including: (Cognitive Behavioral Therapy (CBT), Rational Emotive Behavioral Therapy (REBT), Mindfulness-Based Therapy, Group Therapy, Gratitude Therapy, Reality Therapy, Supportive spiritual techniques)
| Study group | Role | What they receive |
|---|---|---|
| Integrative Therapeutic Program Group | Experimental | Participants in this arm will receive an integrative therapeutic program designed to enhance psychological hardiness among hard-of-hearing female students. The program includes structured training sessions focusing on cognitive, emotional, and behavioral strategies to improve resilience, coping skills, and adaptation to psychological stress.
Participants will attend scheduled sessions over 4 Weeks, and their psychological hardiness will be assessed before and after the intervention using a standardized scale. Receives: Other: Integrative Therapeutic Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Hardiness Scale for deaf and hard of hearing
The final version of the Psychological Hardiness Scale consisted of two sections. The first section included demographic items related to: (degree of hearing loss, grade level, type of hearing assistive device, preferred communication method, parents' hearing status, type of educational environment attended). The second section, which constitutes the main scale, consisted of 24 items distributed across three dimensions: commitment, control, and challenge. Each item was rated using a four-point Likert scale: (1 = Never, 2 = Rarely, 3 = Often, 4 = Always).
Minimum value 1 Maximum value 4 Therefore, a student who scores higher on the scale will have a higher degree of psychological resilience.
Measured: 8 weeks
Change in Psychological Hardiness Scores
This outcome measures the change in psychological hardiness among hard-of-hearing female students using a validated psychological hardiness scale developed by the researchers. The assessment evaluates key dimensions such as commitment, control, and challenge before and after the intervention.
Accordingly, the higher the student's score on the psychological resilience scale between the pre-test and post-test, the more effective the implemented program is considered to be.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start25 Dec 2025
- Primary completion26 Feb 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A comprehensive survey approach was used to collect data from the study population, which consisted of all DHH female students enrolled in inclusive schools at the intermediate and secondary levels in Al-Ahsa Governorate, Kingdom of Saudi Arabia. According to statistics obtained from the Ministry of Education for the 2025-2026 academic year, the total number of eligible students was 74. Five students were excluded, resulting in a final sample of 69 participants. This number represents approximately 93% of the accessible population, which enhances the credibility and representativeness of the findings. However, incomplete participation may reflect certain practical constraints, such as student availability, willingness to participate, or the presence of additional disabilities accompanying hearing impairment. These factors may have contributed to some cases of non-response. Accordingly, these considerations were taken into account when interpreting and generalizing the results. Therefor
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourah Ibrahim Albash, King Faisal University
- Investigators
- Nourah I Albash, Principal investigator, King Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514468
- Sponsor's protocol ID
- Ethics3681
- Other IDs
- It will be added later.
- Acronym
- Integrative
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Integrative Therapeutic Program in Enhancing Psychological Hardiness Among Hard-of-Hearing Female Students in Saudi Arabia
- ClinicalTrials.gov ID
- NCT07514468
- Acronym / sponsor ID
- Integrative / Ethics3681
- Conditions
- Deaf, Hard of Hearing, Hearing Disability
- Keywords
- Integrative therapeutic program, psychological hardiness, hearing impairment, hard-of-hearing middle school students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- King Faisal UniversityUniversity, hospital or other
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 7 Apr 2026 (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 (quasi-experimental study) is to learn whether an integrative therapeutic program can enhance psychological hardiness among hard-of-hearing (HOH) female students in Saudi Arabia (Al-Ahsa Governorate). The main questions it aims to answer are:
- What is the level of psychological hardiness among DHH female students in the Kingdom of Saudi Arabia?
- Are there statistically significant differences in the level of psychological hardiness among DHH female students attributable to the study variables (degree of hearing loss, grade level, hearing assistive device, communication method used, parents' hearing status, and type of educational environment attended)?
- Are there statistically significant differences at the level of (α = 0.05) between the mean scores of the experimental group on the psychological hardiness scale in the pre- and post-measurements?
- Are there statistically significant differences at the level of (α = 0.05) between the mean scores of the experimental and control groups on the post-measurement of the psychological hardiness scale?
Researchers will compare students who participate in the integrative therapeutic program (experimental group) with those who do not (control group) to see if the program leads to improved psychological hardiness.
Participants will:
Complete a psychological hardiness scale before and after the program Participate in the integrative therapeutic training sessions (experimental group only) Continue their regular educational activities without intervention (control group)
Detailed description
This study was conducted to evaluate the effectiveness of an integrative therapeutic program in enhancing psychological hardiness among hard-of-hearing (HOH) female students in inclusive educational settings in Al-Ahsa Governorate, Kingdom of Saudi Arabia. HOH students often face multiple psychological and social challenges that may negatively affect their adaptive functioning and overall well-being. Therefore, this study aimed to provide an evidence-based intervention to strengthen psychological resilience and improve coping capacities within this population.
A quasi-experimental design with a non-randomized experimental and control group structure was adopted. The study initially involved a broader sample of 69 deaf and hard-of-hearing (DHH) female students. All participants were assessed using a Psychological Hardiness Scale developed and validated by the researchers. Based on (pre-test) results, a purposive sample of 25 HOH students who demonstrated relatively low levels of psychological hardiness was selected to participate in the intervention phase.
The selected participants were divided into two groups: an experimental group (n = 15), which received the integrative therapeutic program, and a control group (n = 10), which did not receive any intervention during the study period. The intervention program was designed to enhance key dimensions of psychological hardiness, including commitment, control, and challenge, through structured therapeutic activities and training sessions tailored to the communication abilities and learning needs of HOH students.
All participants underwent pre-test and post-test assessments using the same psychological hardiness scale. The primary outcome measure was the change in psychological hardiness scores between pre-test and post-test evaluations. The effectiveness of the intervention was determined by comparing within-group changes (pre- vs. post-test) and between-group differences (experimental vs. control group). The higher the student's score on the scale, the greater the improvement in her level of psychological hardiness.
The independent variable in this study was the integrative therapeutic program, while the dependent variable was psychological hardiness. Although the study design aimed to control for confounding variables, several external factors may have influenced the outcomes, including parental support, teacher preparedness, peer interactions, and the broader educational and social environment.
The findings demonstrated statistically significant improvements in psychological hardiness among participants in the experimental group compared to the control group, indicating the effectiveness of the implemented program. These results support the integration of structured therapeutic interventions within educational support services for HOH students to enhance their psychological well-being and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A comprehensive survey approach was used to collect data from the study population, which consisted of all DHH female students enrolled in inclusive schools at the intermediate and secondary levels in Al-Ahsa Governorate, Kingdom of Saudi Arabia. According to statistics obtained from the Ministry of Education for the 2025-2026 academic year, the total number of eligible students was 74. Five students were excluded, resulting in a final sample of 69 participants. This number represents approximately 93% of the accessible population, which enhances the credibility and representativeness of the findings. However, incomplete participation may reflect certain practical constraints, such as student availability, willingness to participate, or the presence of additional disabilities accompanying hearing impairment. These factors may have contributed to some cases of non-response. Accordingly, these considerations were taken into account when interpreting and generalizing the results. Therefor
| Arm | Type | Receives |
|---|---|---|
| Integrative Therapeutic Program Group | Experimental | Other: Integrative Therapeutic ProgramParticipants in this arm will receive an integrative therapeutic program designed to enhance psychological hardiness among hard-of-hearing female students. The program includes structured training sessions focusing on cognitive, emotional, and behavioral strategies to improve resilience, coping skills, and adaptation to psychological stress. Participants will attend scheduled sessions over 4 Weeks, and their psychological hardiness will be assessed before and after the intervention using a standardized scale. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Female students with hearing impairment (Hard of Hearing, HOH)
- Enrollment in inclusive schools in Al-Ahsa Governorate, Saudi Arabia
- Within the targeted educational stage of the study
- Low scores on the Psychological Hardiness Scale at (pre-test)
- Ability to participate in and complete the intervention program
Key exclusion criteria (4 listed)
- Failure to provide informed consent
- Incomplete participation in (pre-test) or post-intervention (post-test) assessments
- Diagnosis of profound deafness that limits effective communication required for the intervention
- Male students (excluded due to logistical and cultural constraints related to intervention delivery)
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 |
|---|---|---|
| Integrative Therapeutic ProgramThe therapeutic program was developed based on the integrative therapy approach, which involves combining techniques and strategies derived from multiple therapeutic schools in accordance with the characteristics of the target population, without adhering to a single theoretical framework. The integrative approach draws on contemporary integrative perspectives that emphasize flexibility in intervention according to the needs of beneficiaries. The program was also grounded in the psychological hardiness theory developed by Suzanne Kobasa, which conceptualizes hardiness through three dimensions: commitment, control, and challenge. In addition, the program incorporated techniques drawn from several therapeutic approaches, including: (Cognitive Behavioral Therapy (CBT), Rational Emotive Behavioral Therapy (REBT), Mindfulness-Based Therapy, Group Therapy, Gratitude Therapy, Reality Therapy, Supportive spiritual techniques) | Other | Integrative Therapeutic Program Group |
Primary outcome
Psychological Hardiness Scale for deaf and hard of hearing
Time frame: 8 weeks
The final version of the Psychological Hardiness Scale consisted of two sections. The first section included demographic items related to: (degree of hearing loss, grade level, type of hearing assistive device, preferred communication method, parents' hearing status, type of educational environment attended). The second section, which constitutes the main scale, consisted of 24 items distributed across three dimensions: commitment, control, and challenge. Each item was rated using a four-point Likert scale: (1 = Never, 2 = Rarely, 3 = Often, 4 = Always). Minimum value 1 Maximum value 4 Therefore, a student who scores higher on the scale will have a higher degree of psychological resilience.
Change in Psychological Hardiness Scores
Time frame: 8 weeks
This outcome measures the change in psychological hardiness among hard-of-hearing female students using a validated psychological hardiness scale developed by the researchers. The assessment evaluates key dimensions such as commitment, control, and challenge before and after the intervention. Accordingly, the higher the student's score on the psychological resilience scale between the pre-test and post-test, the more effective the implemented program is considered to be.
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 7 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Nourah I Albash principal investigator
King Faisal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Therapeutic Program in people with Deaf and Hard of Hearing, run by King Faisal University at 1 site in Saudi Arabia.
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 4 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 7 Apr 2026. 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 Saudi Arabia. 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?
Psychological Hardiness Scale for deaf and hard of hearing (time frame: 8 weeks). The study lists 2 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 7 Apr 2026.