NCT06535100

Brief Summary

Special needs individuals with mental disabilities and other special conditions accompanying mental needs (hearing disability, visual disability, physical disability, autism spectrum disorder, multiple disabilities, language and speech disorder, learning disability and emotional/behavioral disorder) are diagnosed with special needs individuals. It includes mothers who are in service. Caregivers of children with mental special needs may experience mental problems such as anxiety, hopelessness and depression, which negatively affects the caregiver's mental resilience and increases their care burden. In order to reduce the care burden, artistic activities will be organized to express the emotions of caregivers.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

June 3, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2024

Completed
Last Updated

October 15, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

July 8, 2024

Last Update Submit

October 10, 2024

Conditions

Child Behavior Problem

Keywords

Child Behavior Problem

Outcome Measures

Primary Outcomes (1)

  • increasing mental well-being

    enabling mothers to take a positive path in communication

    seven weeks apply

Study Arms (2)

trial (initiative will be implemented)

EXPERIMENTAL

Art therapy artistic therapy, wood painting, lithography, jewelry design, mud free shaping, expression workshop and training workshops

Behavioral: Art therapy

control

NO INTERVENTION

standart care

Interventions

Art therapyBEHAVIORAL

artistic therapy, wood painting, lithography, jewelry design, mud free shaping, expression workshop and training workshops

trial (initiative will be implemented)

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kastamonu University

Kastamonu, Kastamonu, 37300, Turkey (Türkiye)

RECRUITING

Kastamonu Üniversity

Kastamonu, Kastamonu, 37300, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Art Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Havva Kaçan, Dr

    hkacan@kastamonu.edu.tr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Havva Kaçan, Dr

CONTACT

05057753893hkacan@kastamonu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof, Director

Study Record Dates

First Submitted

July 8, 2024

First Posted

August 2, 2024

Study Start

June 3, 2024

Primary Completion

October 17, 2024

Study Completion

November 17, 2024

Last Updated

October 15, 2024

Record last verified: 2024-08

Locations

TU(2)