NCT05587647

Brief Summary

Negative emotions experienced during life processes and the burden of caregiving affect the quality of life of parents. It has been found that parents who care for their children with intellectual disability (ID) for a long time have difficulties in coping with stress and their quality of life is adversely affected. However, families play a key role in maintaining the care of their children with ID, so it is very important that parents are supported in the matters they need.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

October 17, 2022

Last Update Submit

January 10, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Personal Information Form

    The personal information form consists of various socio-demographic questions about the participant and the mentally handicapped child, such as gender, age and educational status.

    All mothers will be asked to fill in 1 hour before the training.

  • Beach Center Family Quality of Life (BCFQOL) Scale

    The scale, developed by University of Kansas Beach Center on Family and Disability (2006) (Beach Center on Disability at the University of Kansas in partnership with families, 2006) and adapted into Turkish by Meral et al. (2012), consists of 25 questions, five sub-dimensions and 5 It is a data collection tool consisting of likert-type responses. The scale aims to determine the quality of life of families with children with special needs.

    Immediately after the training is completed (average of 5 minutes), mothers will be asked to complete this scale.

  • Beach Center Family Quality of Life (BCFQOL) Scale

    The scale, developed by University of Kansas Beach Center on Family and Disability (2006) (Beach Center on Disability at the University of Kansas in partnership with families, 2006) and adapted into Turkish by Meral et al. (2012), consists of 25 questions, five sub-dimensions and 5 It is a data collection tool consisting of likert-type responses. The scale aims to determine the quality of life of families with children with special needs.

    One month after the training is completed, mothers will be asked to complete this scale to evaluate the effectiveness of the training.

  • Perceived Stress Scale

    The scale developed by Cohen, Kamarck, and Mermelstein (1983) to measure how individuals evaluate stressful life events as unpredictable, uncontrollable and difficult to cope with in the last month consists of 10 items.

    Immediately after the training is completed (average of 5 minutes), mothers will be asked to complete this scale.

  • Perceived Stress Scale

    The scale developed by Cohen, Kamarck, and Mermelstein (1983) to measure how individuals evaluate stressful life events as unpredictable, uncontrollable and difficult to cope with in the last month consists of 10 items.

    Immediately afteImmediately after the training is completed (average of 5 minutes), mothers will be asked to complete this scale.r the training is completed (average of 5 minutes), mothers will be asked to complete this scale.

Study Arms (2)

Experimental: YEGEP group/Intervention

EXPERIMENTAL

Mothers will be informed about the program and invited to work. In the phone call, information will be given about the purpose, duration, requirements and volunteering of the study. The planned training schedule will be applied to these mothers.

Other: Transition to Adulthood Education Program

Control group

NO INTERVENTION

Annual care trainings are given to parents at the disabled center where the study will be conducted. There is no similar practice to these mothers on the same dates. place in the control group

Interventions

YEGEP was developed by the authors based on the information in the literature, based on the needs of mothers of children who have reached adulthood or are going through. Three training modules are planned in line with current requirements. Education will also be supported by audio-visual and written materials. It is planned that the trainings, which will last for 3 weeks in total, for 1 hour a week for each group, in the form of 3 sessions of 1 hour with these contents, will be held at a disabled center. Titles of training modules: 1. Developmental Period Characteristics of Young Adults with Intellectual Disabilities (Transition to Adulthood, Future Planning / Social Life (employment, peers, etc.) 2. Protecting and Sustaining the Health of Young Adult with Intellectual Disabilities 3. Coping with Stress

Also known as: There is no other intervention
Experimental: YEGEP group/Intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Whose child is registered with the disability center,
  • Have a young adult child between the ages of 20 and 35 with moderate and severe mental disabilities,
  • Speaking Turkish and literate Turkish,
  • Not visually and speech impaired,
  • Mothers who volunteered to participate in the study will be included.

You may not qualify if:

  • Mothers who did not volunteer to participate in the study and were illiterate in Turkish were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koc University

Istanbul, 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching and Research Assistant

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 20, 2022

Study Start

January 1, 2023

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations