Therapeutic RecreationNCT04546464
The Effects of Therapeutic Recreation Activities on Aberrant Behaviours of Individuals With Intellectual Disabilities
A study testing Therapeutic Recreation Program in people with Therapeutic Recreation and Intellectual Disability, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of Therapeutic Recreation Activities on Aberrant Behavior of Adolescents With Intellectual Disabilities. The research was carried out at Meram Melike Hatun Special Education Vocational School in Konya. The study took place between May 2019 and June 2019. Read more about this study
- Who is it for?
- Ages 15 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Recreation, Intellectual Disability, Recreational Activities
- What is being tested?
- Therapeutic Recreation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 30 Jun 2019
- 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 15 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- -
Who cannot join
- Having a physical disability, Having Down syndrome
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to determine the effect of Therapeutic Recreation Activities on Aberrant Behavior of Adolescents With Intellectual Disabilities.
The research was carried out at Meram Melike Hatun Special Education Vocational School in Konya. The study took place between May 2019 and June 2019. The parents of the participants who participated in the study consisted of the experimental group (n = 16) and the remaining parents (n = 16) formed the control group and the sample group (n = 32). The personal information form which measures demographic characteristics developed by the researchers according to the literature, and The Aberrant Behavior Checklist Scale were used. Data were analyzed in SPSS statistics 23 program. According to Shapiro Wilk test, sample group was not normal. For this reason, non-parametric tests were performed. In descriptive data, the mean, number, percentage will be used; Comparative statistics were made according to the assumptions of non-parametric test (Wilcoxon test, Mann Whitney U test). Therapeutic Recreation Activities was applied as total of 16 sessions, consisting of two sessions per week and each session lasting about 1 hour. The program was implemented by researcher.
- Conditions
- Therapeutic Recreation, Intellectual Disability, Recreational Activities, Aberrant Behaviors
- Being tested
- Therapeutic Recreation Program
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Recreation ProgramBehavioural
The experimental recreation program, which consisted of two sessions per week and lasted approximately
1 hour each session, lasted for 8 weeks between May 2019 and June 2019 for the adolescents in the experimental group. The Therapeutic Recreation Activity Program, which consists of 16 sessions, is organized according to the self-determination and entertainment development model. This model aims to provide individual development and prosperity by creating an entertaining environment with therapeutic recreation. According to the degree of enjoyment, activity improves freedom of choice, preferences and ability to express oneself. Pleasure is a feeling that the participant feels deeply during therapeutic recreation. Provides entertainment experience. Pleasure increases individual motivation to participate, as well as making the best use of physical, social and emotional conditions
| Study group | Role | What they receive |
|---|---|---|
| Experimental Therapeutic Recreation Program | Experimental | The experimental recreation program, which consisted of two sessions per week and lasted approximately
1 hour each session, lasted for 8 weeks between May 2019 and June 2019 for the adolescents in the experimental group. The Therapeutic Recreation Activity Program, which consists of 16 sessions, is organized according to the self-determination and entertainment development model. This model aims to provide individual development and prosperity by creating an entertaining environment with therapeutic recreation. According to the degree of enjoyment, activity improves freedom of choice, preferences and ability to express oneself. Pleasure is a feeling that the participant feels deeply during therapeutic recreation. Provides entertainment experience. Pleasure increases individual motivation to participate, as well as making the best use of physical, social and emotional conditions Receives: Behavioral: Therapeutic Recreation Program |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Aberrant Behavior Checklist total score
The Aberrant Behavior Checklist measures assessing treatment effects on maladaptive behaviors of the people with mental retardation
Measured: through study completion, an average of 1 year
The sub-factor score level of the Aberrant Behavior Checklist have been labeled as follows: Hyperactivity.
Irritability, Agitation, Crying
Measured: through study completion, an average of 1 year
The sub-factor score level of the Aberrant Behavior Checklist have been labeled as follows: Lethargy
Social Withdrawal
Measured: through study completion, an average of 1 year
The sub-factor score level of the Aberrant Behavior Checklist have been labeled as follows: Stereotypic Behavior
repetitive or ritualistic movement, posture, or utterance.
Measured: through study completion, an average of 1 year
The sub-factor score level of the Aberrant Behavior Checklist have been labeled as follows: Self-injury
self injurious behaviors
Measured: through study completion, an average of 1 year
The sub-factor score level of the Aberrant Behavior Checklist have been labeled as follows: Others behaviors
The factor includes the following questions:
Their requests must be fulfilled immediately. They have repeated conversations. His mood changes quickly. Likes to be apart from others
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 May 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic RecreationStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaye Erkmen Hadi, Selcuk University
- Investigators
- Özlem Zengin, pHD, Study chair, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546464
- Sponsor's protocol ID
- 1234567
- Status last verified
- Sep 2020
- First submitted
- 25 Aug 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Therapeutic Recreation Activities on Aberrant Behaviours of Individuals With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT04546464
- Acronym / sponsor ID
- 1234567
- Conditions
- Therapeutic Recreation, Intellectual Disability, Recreational Activities, Aberrant Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 14 Sep 2020 (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 aim of this study was to determine the effect of Therapeutic Recreation Activities on Aberrant Behavior of Adolescents With Intellectual Disabilities.
The research was carried out at Meram Melike Hatun Special Education Vocational School in Konya. The study took place between May 2019 and June 2019. The parents of the participants who participated in the study consisted of the experimental group (n = 16) and the remaining parents (n = 16) formed the control group and the sample group (n = 32). The personal information form which measures demographic characteristics developed by the researchers according to the literature, and The Aberrant Behavior Checklist Scale were used. Data were analyzed in SPSS statistics 23 program. According to Shapiro Wilk test, sample group was not normal. For this reason, non-parametric tests were performed. In descriptive data, the mean, number, percentage will be used; Comparative statistics were made according to the assumptions of non-parametric test (Wilcoxon test, Mann Whitney U test). Therapeutic Recreation Activities was applied as total of 16 sessions, consisting of two sessions per week and each session lasting about 1 hour. The program was implemented by researcher.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Therapeutic Recreation Program | Experimental | Behavioral: Therapeutic Recreation ProgramThe experimental recreation program, which consisted of two sessions per week and lasted approximately 1 hour each session, lasted for 8 weeks between May 2019 and June 2019 for the adolescents in the experimental group. The Therapeutic Recreation Activity Program, which consists of 16 sessions, is organized according to the self-determination and entertainment development model. This model aims to provide individual development and prosperity by creating an entertaining environment with therapeutic recreation. According to the degree of enjoyment, activity improves freedom of choice, preferences and ability to express oneself. Pleasure is a feeling that the participant feels deeply during therapeutic recreation. Provides entertainment experience. Pleasure increases individual motivation to participate, as well as making the best use of physical, social and emotional conditions |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Having a physical disability, Having Down syndrome
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 |
|---|---|---|
| Therapeutic Recreation ProgramThe experimental recreation program, which consisted of two sessions per week and lasted approximately 1 hour each session, lasted for 8 weeks between May 2019 and June 2019 for the adolescents in the experimental group. The Therapeutic Recreation Activity Program, which consists of 16 sessions, is organized according to the self-determination and entertainment development model. This model aims to provide individual development and prosperity by creating an entertaining environment with therapeutic recreation. According to the degree of enjoyment, activity improves freedom of choice, preferences and ability to express oneself. Pleasure is a feeling that the participant feels deeply during therapeutic recreation. Provides entertainment experience. Pleasure increases individual motivation to participate, as well as making the best use of physical, social and emotional conditions | Behavioural | Experimental Therapeutic Recreation Program |
Primary outcome
The Aberrant Behavior Checklist total score
Time frame: through study completion, an average of 1 year
The Aberrant Behavior Checklist measures assessing treatment effects on maladaptive behaviors of the people with mental retardation
The sub-factor score level of the Aberrant Behavior Checklist have been labeled as follows: Hyperactivity.
Time frame: through study completion, an average of 1 year
Irritability, Agitation, Crying
The sub-factor score level of the Aberrant Behavior Checklist have been labeled as follows: Lethargy
Time frame: through study completion, an average of 1 year
Social Withdrawal
The sub-factor score level of the Aberrant Behavior Checklist have been labeled as follows: Stereotypic Behavior
Time frame: through study completion, an average of 1 year
repetitive or ritualistic movement, posture, or utterance.
The sub-factor score level of the Aberrant Behavior Checklist have been labeled as follows: Self-injury
Time frame: through study completion, an average of 1 year
self injurious behaviors
The sub-factor score level of the Aberrant Behavior Checklist have been labeled as follows: Others behaviors
Time frame: through study completion, an average of 1 year
The factor includes the following questions: Their requests must be fulfilled immediately. They have repeated conversations. His mood changes quickly. Likes to be apart from others
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 14 Sep 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Therapeutic Recreation
Not yet recruiting
A Manualized Recreational Therapy Balance Program for Older Adults With Parkinson's and Movement Disorders
Parkinson Disease (PD), Postural Balance, Movement Disorders (Incl Parkinsonism)
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.
Özlem Zengin, pHD study chair
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Recreation Program in people with Therapeutic Recreation and Intellectual Disability, run by Selcuk 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: finished, as of the sponsor's last update on 14 Sep 2020. 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?
The Aberrant Behavior Checklist total score (time frame: through study completion, an average of 1 year). The study lists 6 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 14 Sep 2020.