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The Role of Family Functioning in Adaptation to Being a Caregiver of an Individual With Rett Syndrome

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ClinicalTrials.gov Identifier: NCT00891956
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

Tracking Information
First Submitted Date April 30, 2009
First Posted Date May 1, 2009
Last Update Posted Date September 6, 2019
Study Start Date April 24, 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00891956 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Role of Family Functioning in Adaptation to Being a Caregiver of an Individual With Rett Syndrome
Official Title The Role of Family Functioning in Adaptation to Being a Caregiver of an Individual With Rett Syndrome
Brief Summary

Background:

  • Rett syndrome (RS) is a panethnic (affecting all ethnicities) neurodevelopmental (impairment of the growth and development of the brain) disorder affecting primarily females. RS is characterized by the loss of intellectual functioning, fine and gross motor skills, and communicative abilities after a period of seemingly normal development.
  • Caregivers of individuals with RS face many psychosocial challenges. The stressors can be grouped into the following six categories: emotional difficulties, health-related stressors, uncertainty about their daughter s illness, rejection by their social environment, lack of available or competent experts, and unfavorable comparison with healthy children.
  • Researchers are making a significant contribution to the adaptation literature with a focus on family functioning and to the little psychosocial research that exists on families with RS.
  • Researchers hope to narrow down the most important areas on which to focus for intervention strategies in families with RS.

Objectives:

  • To describe family functioning, perceived illness burden, self-efficacy, types of coping methods, and adaptation in caregivers of individuals with RS to examine the relationships between these variables and the outcomes of family functioning and adaptation.
  • To examine the extent to which appraisals of being a caregiver of an individual with RS and methods of coping are associated with family functioning.
  • To examine the extent to which appraisals of being a caregiver of an individual with RS, methods of coping, and family functioning are associated with caregiver adaptation.

Eligibility:

- Eligibility is based on answering yes to the following three questions: Are you 18 years old or older? Are you the caregiver of a child diagnosed with Rett Syndrome? and Does the child with Rett Syndrome currently reside in your home with you?

Design:

  • Participants in this cross-sectional research design will answer a quantitative survey that includes some open-ended questions. The cross-sectional study involves a one-time self-administered questionnaire that takes approximately 20 to 30 minutes to complete.
  • The survey will be available in paper and electronic versions and includes demographics questions, measures of perceived illness burden, parental self-efficacy, coping methods, family functioning, and adaptation. Participants also will answer open-ended questions related to the individual s diagnosis.
  • Participants may withdraw from the study at any point up until submission of the survey and may skip any question.
  • Participants who experience psychological distress as a result of taking the survey are advised to contact the researcher. Study coordinators at the various clinics from which participants will be recruited will be notified of the possibility of adverse events and instructed to direct any members who experience distress to the appropriate professional services.
  • Participants will receive a small financial compensation for completing the survey.
Detailed Description This study aims to investigate the predictors of family functioning and adaptation in caregivers of individuals with Rett Syndrome (RS), a neurodevelopmental disorder affecting primarily females. After an apparently normal prenatal and postnatal period of development, individuals with RS lose intellectual functioning, fine and gross motor skills including purposeful hand use, and communicative abilities. Individuals with RS also experience a host of other medical problems including seizures and respiratory dysfunction. Prior research demonstrates that caregivers of individuals with RS experience more stress than normative samples and that family functioning plays a role in maternal mental health. However, there is much that is not understood about how cognitive appraisals (thoughts that assess the circumstances), coping methods, and family functioning are related to caregiver adaptation in this population. This study is based on Thompson and colleagues Transactional Stress and Coping Model which conceptualizes family functioning and adaptation to being a caregiver of an individual with RS. A cross-sectional research design using quantitative methodology will explore the relationships between perceived illness burden, self-efficacy, coping methods, family functioning and adaptation. In addition, an open-ended section will be included to qualitatively describe the role of family relationships on the caregivers perception of their ability to care for their child with RS. Caregivers of individuals with RS will be recruited through an international RS organization, a national RS educational meeting, and several national RS clinics. Eligible participants will be able to complete a paper or online version of the survey.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Rett Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 4, 2018)
426
Original Enrollment
 (submitted: April 30, 2009)
600
Study Completion Date January 13, 2016
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:
  • The study population will consist of men and women ages 18 or older who are the primary caregivers of a child with Rett Syndrome.
  • The parent may be a biological or adoptive parent or other primary caregiver and the child must reside with the primary caregiver.
  • Individuals of all ethnic, religious, socioeconomic, and educational backgrounds and from a variety of geographic locations in the United States will be included.

EXCLUSION CRITERIA:

-Participants must be able to read and write in English, as it is essential for the researchers to be able to understand participants responses.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00891956
Other Study ID Numbers 999909132
09-HG-N132
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
Study Sponsor National Human Genome Research Institute (NHGRI)
Collaborators Not Provided
Investigators
Principal Investigator: Barbara B Biesecker National Human Genome Research Institute (NHGRI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date January 13, 2016