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Disability, IntellectualNCT06156124

The Role of Family and Individual Factors in Going Through Adolescence - Perspective of a Healthy Child.

An observational study of Disability, Intellectual and Disability Psychological, run by University of Gdansk at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this observational study is to investigate the specificity of the growing up process in young people with disabled siblings. The functioning of adolescents with disabled siblings as a person growing up in three environments will be examined: family, peers and school. Read more about this study

Who is it for?
Ages 16 to 18 yearsHealthy volunteers can take part
What is being tested?
Psychological tests and psychosocial questionnaires
How many people
320 participants
Where
1 sitePoland
Study dates
13 Jun 2023to 12 Jan 2025
Phase
Observational
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 16 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Polish adolescents having sibling.

Who may be able to join

  • age between 16 and 18 years;
  • having disabled sibling, depending on the group: with intellectual disability or motor disability or with chronic somatic disease (diabetes);
  • participation in the study of one of the parents.
  • Inclusion Criteria to the group having sibling without disability (control group):
  • age between 16 and 18 years;
  • having healthy siblings without any disability;
  • participation in the study of one of the parents.

Who cannot join

  • siblings with multiple disabilities, e.g. intellectual and motor disabilities.
  • Exclusion Criteria to the control group and groups having disabled sibling:
  • being an adolescent with disability/disorder/disease;
  • age below 16 and above 18 years.

Trial locations and contacts

1 site in 1 country.

Ariadna B Łada-Maśko, M.A. contact

+48 607 713 958

ariadna.lada@ug.edu.pl

Małgorzata Lipowska, Prof. contact

+48 502 334 687

malgorzata.lipowska@ug.edu.pl

Poland1 site, 1 recruiting
  • University of Gdansk

    Gdansk, Pomeranian Voivodeship, 80-309

    Ariadna B Łada-Maśko, M.A., +48 607 713 958, ariadna.lada@ug.edu.pl

    Małgorzata Lipowska, Prof., +48 502334687, malgorzata.lipowska@ug.edu.pl

    Recruiting

Other trials in Poland

About this study

Official title: Growing up With Disabled Siblings - Opportunity or a Threat to Development? The Role of Family and Individual Factors in Going Through Adolescence - Perspective of a Healthy Child.

The goal of this observational study is to investigate the specificity of the growing up process in young people with disabled siblings. The functioning of adolescents with disabled siblings as a person growing up in three environments will be examined: family, peers and school.

The main questions it aims to answer are:

Read more
  • Does having a disabled sibling influence the functioning of a healthy child in the family system?
  • Do siblings of disabled children show a higher level of maturity than their peers with properly developing siblings?
  • Does having a disabled sibling modify a child's functioning among peers?
  • Does having a disabled sibling modify healthy adolescent's educational experience?
  • Is there a greater risk of psychological disorders among siblings of disabled children than among siblings of normally developing children?

The 160 participants' dyads will take part in the study: healthy adolescent having disabled sibling and one of his/her parents. The parents' participation is necessary to assess the presence of possible internalizing and externalizing disorders among adolescents taking part in the study. The healthy adolescent will be filling out questionnaires regarding the remaining studied variables: functioning in the family - siblings relations, parental attitudes; at school - school achievement, extracurricular activities; relations with peers - time spending with peers, number of friends, as well as the growing up process trajectory - parentification and the way of going through an adolescent crisis.

Researchers will compare four groups (40 dyads in each group): three groups of adolescents having disabled sibling 1) intellectual disability, 2) motor disability, 3) chronic somatic disease, and 4) control group - healthy adolescent having sibling without any disability, to see if they differ from each other referring to the studied variables.

Read the detailed description

Background: Having a disabled sibling can be a source of extremely important and enriching experiences that foster both, the development of socio-emotional competences, as well as broaden the child's perspective and knowledge. However, the presence of the disabled child in the family, also poses many challenges for their siblings, especially in adolescence. Thus, having a disabled sibling is analysed in the literature from two main perspectives: threat and opportunity for development: 1) Children with disabled siblings often receive less attention from their parents and friends. They often experience a sense of injustice and anger, which may then result in hyperactivity, irritation and aggression manifested in school and peer functioning. Research also indicates that adolescents in this group exhibit higher levels of depression, separation anxiety, and internalizing behaviors. 2) The resource perspective, in turn, indicates a higher sense of responsibility, self-efficacy and pride in caring for sick siblings. There is less quarrel and competition among siblings, increased level of empathy, as well as an increase in self-control, tolerance and understanding are observed in siblings of children with disabilities.

Current scientific research on the functioning of families with a disabled child has focused mainly on relations with parents, parental roles, teachers, and medical staff surrounding the disabled child. The role of siblings has been limited. Therefore, the aim of the project is to investigate the specificity of the growing up process in young people with disabled siblings. The functioning of adolescents with disabled siblings as a person growing up in three environments: family, peers and school will be examined.

Participants: 160 participants' dyads will take part in the study: healthy adolescent having disabled sibling and one of his/her parents. Participants will be divided in four groups (40 dyads in each group): three groups of adolescents having disabled sibling 1) intellectual disability, 2) motor disability, 3) chronic somatic disease, and 4) control group - healthy adolescent having sibling without any disability, one of the parents will take part in the study together with every teenager.

Methodology: The proposed research model focuses both, on the difficulties associated with having a disabled sibling (e.g. possible occurrence of disorders), as well as resources (e.g. the higher quality of relationships in the family, especially in the sibling subsystem). The parents' participation is necessary to assess the presence of possible internalizing and externalizing disorders among adolescents taking part in the study. The healthy adolescent will be filling out questionnaires regarding the remaining studied variables: functioning in the family - siblings relations, parental attitudes; at school - school achievement, extracurricular activities; relations with peers - time spending with peers, number of friends, as well as the growing up process trajectory - parentification and the way of going through an adolescent crisis.

Being tested
Psychological tests and psychosocial questionnaires
Keywords
siblings, disability, teenagers, adolescence, family, adolescent crisis, development, internalizing and externalizing disorders, resiliency
Medical subject headings
Intellectual Disability, Developmental Disabilities, Diabetes Mellitus, Adolescent Behavior, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychological tests and psychosocial questionnairesDiagnostic test

    Assessment of psychological functioning of adolescents (including occurrence of internalizing and externalizing problems, coping with adolescent crisis), family functioning (siblings relations, parental attitudes, parentification), functioning at school (school achievement, extracurricular activities), relations with peers (time spending with peers, number of friends, quality of relations). Further, the sociodemographic variables will be also measured.

Study groups in NCT06156124
Study groupRoleWhat they receive
Adolescents having sibling with intellectual disabilityDyads of healthy Polish adolescents 16-18 y.o., who have sibling with intellectual disability and one of their parent. The parent's participation is necessary to assess the presence of possible disorders in a healthy child.
Receives: Diagnostic Test: Psychological tests and psychosocial questionnaires
Adolescents having sibling with motor disabilityDyads of healthy Polish adolescents 16-18 y.o., who have sibling with motor disability and one of their parent. The parent's participation is necessary to assess the presence of possible disorders in a healthy child.
Receives: Diagnostic Test: Psychological tests and psychosocial questionnaires
Adolescents having sibling with diabetesDyads of healthy Polish adolescents 16-18 y.o., who have sibling with chronic somatic disease - diabetes, and one of their parent. The parent's participation is necessary to assess the presence of possible disorders in a healthy child.
Receives: Diagnostic Test: Psychological tests and psychosocial questionnaires
Adolescents having healthy siblingDyads of healthy Polish adolescents 16-18 y.o., who ave healthy sibling, and one of their parent. The parent's participation is necessary to assess the presence of possible disorders in a healthy child.
Receives: Diagnostic Test: Psychological tests and psychosocial questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Siblings relations

    Questionnaire of Relationships with Siblings. Questionnaire consist of 20 items, composed of three subscales: 1) cohesion, 2) communication, and 3) rivalry. The study participants evaluate the frequency of experiencing the given feelings and behaviors about sibling on 5-point Likert-type scale (from 1 - never, to 5 - very often).

    Measured: June 13, 2023 until January 12, 2025

  2. Parental Attitudes

    Parental Attitude Scale - 2. The questionnaire enables the evaluation of five parental attitudes: Acceptance-rejection, Demanding, Autonomy, Inconsistency, and Overprotective. The questionnaire consists of 45 items (separately for mother and father). The participants provide answers on a 5-point scale, assessing which answer best corresponds to the behavior of the mother/father towards the adolescent (from 1 - not true at all to 5 - completely true).

    Measured: June 13, 2023 until January 12, 2025

  3. Relations with peers

    Relationships with peers will be assessed on the basis of the answers given to the questions in the survey created for the purposes of the study. The questions will consider issues such as: amount of time spend with peers, number of close friends, participation in joint activities with peers. Furthermore to investigate the adolescents' quality of life in terms of relationship with peers and support from them the Polish adaptation of KidScreen-27 will be used. This questionnaire, consists of 27 items. Adolescent answers the given questions on 5-point scale (from 1 - never to 5 - always. The KidScreen-27 measures five dimensions of quality of life 1) physical well-being, 2) psychological well-being, 3) parent relationships and autonomy, 4) social support and peers, and 5) school environment. The social support and peers dimension will be used in the research.

    Measured: June 13, 2023 until January 12, 2025

  4. Functioning at school

    Functioning at school will be assessed on the basis of the answers given to the questions in the survey created for the purposes of the study. The questions will consider issues such as: school achievement (arithmetical mean grade is reported for students on the yearly certificate of class completion, in our study will be self-reported by adolescent), extracurricular activities.

    Measured: June 13, 2023 until January 12, 2025

  5. Quality of life in school environment dimension

    The Polish adaptation of KidScreen-27 will be used to investigate adolescent's quality of life in school environment dimension, which refers to adolescents' feelings towards school, their relationships with teachers and ability to concentrate and learn.

    Measured: June 13, 2023 until January 12, 2025

  6. Parentification

    Parentification Questionnaire for Youth - PQY. The self-report questionnaire captures the multidimensional nature of parentification. PQY consists of 26 items, participants rated their responses 5-point Likert-type scale (1 - never true, to 5 - always true). The scale is composed of four subscales: 1) emotional parentification toward parents, 2) instrumental parentification toward parents, 3) sense of injustice, and 4) satisfaction with the role; and additional two subscales for adolescents who have siblings: 1) instrumental parentification toward siblings, and 2) emotional parentification toward siblings. The above PQY questionnaire does not provide a total score, and score for each subscale is calculated as the mean of the ratings for the subscale items.

    Measured: June 13, 2023 until January 12, 2025

  7. Adolescent crisis

    Teenage Rebellion Questionnaire to assess one of the manifestations of the adolescent crisis - teenage rebellion. Part I describes 39 situations in which teenagers may rebel. These situations refer to three triggers (limitations, threats or discrepancies) and contain a description of a specific subject of rebellion. Part II of the questionnaire contains descriptions relating to four subject groups: 1) behaviors that are a manifestation of rebellion and the reasons for refraining from manifesting rebellion outside; 2) the judgments underlying the rebellion; 3) emotions related to rebellion; and 4) indicators on the basis of which adolescents distinguish rebellion from other mental states. The results obtained in the second part of the questionnaire make it possible to recreate the behaviors, judgments and emotions involved in adolescent rebellion that are characteristic of an individual.

    Measured: June 13, 2023 until January 12, 2025

  8. Clinical problems

    Child Behavior Checklist 6-18 (CBCL). CBCL is a widely known parent measure of emotional and behavioral problems in children and adolescents ages 6-18 years. CBCL consist of 113 items and several scales, which are arranged hierarchically. Each level of the hierarchy reflects a range of different emotional and behavioral problems. At the top of this hierarchy are the Internalizing Domain and the Externalizing Domain. The Internalizing Domain: includes three narrower scales of syndromes 1) Anxious/Depressed, 2) Withdrawn/Depressed, and 3) Somatic Complaints, whereas the Externalizing Domain includes 1) Rule Breaking Behavior and 2) Aggressive Behavior syndrome scales.

    Measured: June 13, 2023 until January 12, 2025

Secondary outcomes (1)
  1. Sociodemographic data

    Authors survey of socio-demographic data including: sex, age, place of residence, school, class, parents education level and work, number of siblings (brothers and sisters separately), age of the siblings.

    Measured: June 13, 2023 until January 12, 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2023
  2. Study start13 Jun 2023
  3. Primary completion12 Jan 2025 (estimated)
  4. Study completion12 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06156124
Sponsor's protocol ID
2021/41/N/HS6/00864
Status last verified
Dec 2023
First submitted
30 Aug 2023
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Disability, Intellectual and Disability Psychological, run by University of Gdansk at 1 site in Poland.

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 7 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: status not confirmed, as of the sponsor's last update on 5 Dec 2023. 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 Poland. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ariadna B Łada-Maśko, M.A. (+48 607 713 958, ariadna.lada@ug.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Siblings relations (time frame: June 13, 2023 until January 12, 2025). The study lists 8 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 5 Dec 2023.

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