Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03775135
Status:
WITHDRAWN
Last Update Posted:
2018-12-13
First Post:
2018-11-13
Brief Title:
Identity Development in Youth With Neuromuscular Diseases
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Identity Development in Youth With Neuromuscular Diseases A Clinically Relevant But Forgotten Issue in the Transition to Adulthood
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Changed plans
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Up to 20 of the adolescents worldwide are diagnosed with a chronic illness Although its known that these young people suffer from a wide range of physical discomfort in real life they have to cope with much more challenges whether or not caused by their physical situation Psychiatric disorders eg ASS ADHD or depression are more often diagnosed in this population compared to their healthy peers The causal mechanisms for this higher risk however are yet unknown
This project examines three underlying intrapersonal processes possibly having an impact on the evolution of these secondary symptoms Previous research confirmed the significant impact of having a chronic illness on the development of identity and the association with a higher prevalence of depressive symptoms Identity formation is a crucial developmental task to transfer from a child to an independent responsible adult We believe this developmental task is more at risk for youngsters and young adults suffering from a physical disability caused by a neuromuscular disease In this longitudinal research project we investigate the development of identity in youth with a neuromuscular disease compared to healthy peers and compared to a group of peers with a non-visible chronical illness We also evaluate the impact of the degree of physical functioning on those mechanisms Second we examine if parental behavior and parental functioning is linked with the formation of identity in a neuromuscular populations Finally the impact of identity formation on psychosocial outcomes eg feelings of depression and anxiety quality of life is measured
By addressing these research questions this project will add substantially to our knowledge on identity in chronic illness and can inform future prevention and intervention efforts targeting illness adaptation and parental functioning in order to prevent negative psychosocial outcomes and to optimize quality of life
This project examines three underlying intrapersonal processes possibly having an impact on the evolution of these secondary symptoms Previous research confirmed the significant impact of having a chronic illness on the development of identity and the association with a higher prevalence of depressive symptoms Identity formation is a crucial developmental task to transfer from a child to an independent responsible adult We believe this developmental task is more at risk for youngsters and young adults suffering from a physical disability caused by a neuromuscular disease In this longitudinal research project we investigate the development of identity in youth with a neuromuscular disease compared to healthy peers and compared to a group of peers with a non-visible chronical illness We also evaluate the impact of the degree of physical functioning on those mechanisms Second we examine if parental behavior and parental functioning is linked with the formation of identity in a neuromuscular populations Finally the impact of identity formation on psychosocial outcomes eg feelings of depression and anxiety quality of life is measured
By addressing these research questions this project will add substantially to our knowledge on identity in chronic illness and can inform future prevention and intervention efforts targeting illness adaptation and parental functioning in order to prevent negative psychosocial outcomes and to optimize quality of life
Detailed Description:
A large-scale multi-informant two-wave longitudinal study is proposed to investigate our three different research objectives using complementary methods and multiple sources for data collection Such a longitudinal design allows for examining developmental trajectories of our core identity variables as well as examining how these identity variables are related to other variables over time As such we will investigate integrative pathways linking contextual factors to identity development and broader psychosocial functioning enabling us to forward important information for clinical practice Before the start of the study an approval from the ethical commission will be obtained All data will be coded anonymously and stored in a confidential database We aim to recruit 200 adolescents and emerging adults with a neuromuscular disease like DMD patients Duchenne Muscular Dystrophy SMA patients Spinal Muscular Atrophy CMT patients Charcot Marie Tooth and MD1 patients Myotonic Dystrophy type 1 Patients will be included in this study if they meet the following criteria confirmed diagnoses of a neuromuscular disorder aged 12-25 years at baseline last neuromuscular consult at our NMRC is 5 or less years ago able to read and write Dutch and valid contact details available in the clinical database or the hospital information system Given the complex data-analyses it is difficult to perform an exact power analysis but the anticipated sample size is suited for the planned analyses Kline 2005 To make a useful comparison we will include a control sample of age- and gender-matched healthy adolescents and a group of age- and gender-matched adolescents diagnosed with type 1 diabetes Those control participants will be recruited in secondary schools and universities while we are able to use the data of an ongoing research project in patients with diabetes To achieve these aims this project as noted will be in cooperation with the research team from the Faculty of Psychology and Educational Sciences at KU Leuven
To investigate our objectives data will be systematically collected during two years on two different occasions T1 and T2 with one year between subsequent time-points All neuromuscular patients are supposed to consult their multidisciplinary team every 6 months in the context of a general control and this gives us the opportunity to ask both adolescents and parents to complete questionnaires once a year Depending on the date of the appointment patients will start in this survey on different moments but we will use the same time interval between time-points for every single patient For inclusion adolescents and parents will be asked to sign informed consents where after demographic and clinical data can be obtained anonymously from the patients medical records Additional demographic and socio-economic information will be gathered using a demographic questionnaire at T1 Other data will be collected using instruments with well-established psychometric characteristics that mostly include self-reports on all two time-points T1 and T2 Parents will also be asked to report on youth functioning as well Figure 2 shows an overview of our research design and estimated timeline
In order to investigate objective 1 adolescents will be asked to complete following questionnaires on the two different time-points Dimensions of Identity Development Scale 25 items Illness Identity Resolution Scale 27 items and Brief Illness Perception Questionnaire 8 items In addition to examine reciprocal associations between identity development and the variables forwarded under objectives 2 en 3 adolescents will be asked to complete self-report questionnaires on psychosocial functioning and perceived support using the Center for Epidemiologic Studies Depression Scale CESD 20 items to screen for depressive symptoms the Screen for Child Anxiety Related Emotional Disorders SCARED-NL the PedsQLTM Neuromuscular Module to measure quality of life and the Inventory of Peer and Parent Attachment subscales Trust Communication and Alienation 12 items At the same time-points parents will be asked to complete the Illness Intrusive Scale 13 items a scale about different factors of their parenting responsiveness 7 items psychological control 8 items behavioral control 7 items and overprotectionanxious parenting 8 items Parenting Questionnaire and about the physical dependence of their child Activ-Lim To report about the psychosocial functioning of their child parents will be asked to fulfill the Screen for Child Anxiety Related Emotional Disorders SCARED-NL and the PedsQLTM Neuromuscular Module to measure perceived quality of life in the youngster For evaluating their own psychosocial functioning they will be asked to complete the Center for Epidemiologic Studies Depression Scale 20 items and a LAS-scale to evaluate their own quality of life Necessary measures will be taken to minimize dropout all participants receive a reward and Dillmans approach will be used to minimize non-response Occasional missing data will be dealt with using appropriate methods Enders 2010 State-of-the-art longitudinal techniques will be used Cross-lagged analysis will be used to examine directionality of effect with appropriate controls for all within-time associations and stability coefficients Hence we can investigate for instance whether parents actually predict illness identity resolutions over time or whether reciprocal effects emerge with for instance illness acceptance also leading to more support Further mediation will be tested from a longitudinal perspective allowing us to examine for instance whether illness identity resolutions mediate the associations between parental support and outcomes To chart developmental trajectories over time latent growth curve modeling estimates both linear and non-linear growth and uses information collected at all different time points to derive parameters of change ie intercept and slope Finally latent class growth analysis will be used to identify distinct developmental trajectory classes in terms of personal and illness identity resolutions
To investigate our objectives data will be systematically collected during two years on two different occasions T1 and T2 with one year between subsequent time-points All neuromuscular patients are supposed to consult their multidisciplinary team every 6 months in the context of a general control and this gives us the opportunity to ask both adolescents and parents to complete questionnaires once a year Depending on the date of the appointment patients will start in this survey on different moments but we will use the same time interval between time-points for every single patient For inclusion adolescents and parents will be asked to sign informed consents where after demographic and clinical data can be obtained anonymously from the patients medical records Additional demographic and socio-economic information will be gathered using a demographic questionnaire at T1 Other data will be collected using instruments with well-established psychometric characteristics that mostly include self-reports on all two time-points T1 and T2 Parents will also be asked to report on youth functioning as well Figure 2 shows an overview of our research design and estimated timeline
In order to investigate objective 1 adolescents will be asked to complete following questionnaires on the two different time-points Dimensions of Identity Development Scale 25 items Illness Identity Resolution Scale 27 items and Brief Illness Perception Questionnaire 8 items In addition to examine reciprocal associations between identity development and the variables forwarded under objectives 2 en 3 adolescents will be asked to complete self-report questionnaires on psychosocial functioning and perceived support using the Center for Epidemiologic Studies Depression Scale CESD 20 items to screen for depressive symptoms the Screen for Child Anxiety Related Emotional Disorders SCARED-NL the PedsQLTM Neuromuscular Module to measure quality of life and the Inventory of Peer and Parent Attachment subscales Trust Communication and Alienation 12 items At the same time-points parents will be asked to complete the Illness Intrusive Scale 13 items a scale about different factors of their parenting responsiveness 7 items psychological control 8 items behavioral control 7 items and overprotectionanxious parenting 8 items Parenting Questionnaire and about the physical dependence of their child Activ-Lim To report about the psychosocial functioning of their child parents will be asked to fulfill the Screen for Child Anxiety Related Emotional Disorders SCARED-NL and the PedsQLTM Neuromuscular Module to measure perceived quality of life in the youngster For evaluating their own psychosocial functioning they will be asked to complete the Center for Epidemiologic Studies Depression Scale 20 items and a LAS-scale to evaluate their own quality of life Necessary measures will be taken to minimize dropout all participants receive a reward and Dillmans approach will be used to minimize non-response Occasional missing data will be dealt with using appropriate methods Enders 2010 State-of-the-art longitudinal techniques will be used Cross-lagged analysis will be used to examine directionality of effect with appropriate controls for all within-time associations and stability coefficients Hence we can investigate for instance whether parents actually predict illness identity resolutions over time or whether reciprocal effects emerge with for instance illness acceptance also leading to more support Further mediation will be tested from a longitudinal perspective allowing us to examine for instance whether illness identity resolutions mediate the associations between parental support and outcomes To chart developmental trajectories over time latent growth curve modeling estimates both linear and non-linear growth and uses information collected at all different time points to derive parameters of change ie intercept and slope Finally latent class growth analysis will be used to identify distinct developmental trajectory classes in terms of personal and illness identity resolutions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None