NCT04546464

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

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 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

August 25, 2020

Last Update Submit

September 4, 2020

Conditions

Outcome Measures

Primary Outcomes (6)

  • The Aberrant Behavior Checklist total score

    The Aberrant Behavior Checklist measures assessing treatment effects on maladaptive behaviors of the people with mental retardation

    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

    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

    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.

    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

    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

    through study completion, an average of 1 year

Study Arms (2)

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

Behavioral: Therapeutic Recreation Program

Standard care

NO INTERVENTION

Interventions

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

Experimental Therapeutic Recreation Program

Eligibility Criteria

Age15 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • Having a physical disability, Having Down syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, 42400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Özlem Zengin, pHD

    Researcher

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 14, 2020

Study Start

May 1, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

September 14, 2020

Record last verified: 2020-09

Locations