Predictors of Caregiver Adaptation to Pervasive Developme... | NCT00496210

Studies
Predictors of Caregiver Adaptation to Pervasive Developmental Disorders

NCT00496210

Sponsor

National Human Genome Research Institute (NHGRI)

Status

Completed

Last Update Posted

Nov 15, 2019Actual

Enrollment

324Actual

Phase

Not provided

Conditions

Autism
Asperger's Syndrome
Rett's Disorder

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
07-HG-N178

Status Module

Record Verification Date

Dec 7, 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 27, 2007

Primary Completion Date

Not provided

Completion Date

Dec 7, 2015

First Submitted Date

Jul 3, 2007

First Submission Date that Met QC Criteria

Jul 3, 2007

First Posted Date

Jul 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2019

Last Update Posted Date

Nov 15, 2019Actual

Description Module

Brief Summary

This study will explore predictors of how caregivers might adapt to children diagnosed with a pervasive developmental disorder (PDD), including autism, Asperger s syndrome, childhood disintegrative disorder, Rett s disorder or other not specified PDD. PDD presents particular challenges for caregivers because of the communication and socialization challenges of affected children and because of the uncertainty surrounding the cause, prognosis and recurrence risks.

People 18 years of age or older who are the primary caregiver for a child diagnosed with a PDD may be eligible for this study. Participants fill out a survey, either online or in hard copy, that includes information in the following categories:

How being a caregiver for a child with a PDD has impacted the caregiver.
How much control the caregiver feels that he or she or others have over certain aspects of their child s PDD.
What the caregiver thinks caused the child s PDD.
What coping techniques the caregiver uses in caring for a child with a PDD.
How uncertain the caregiver feels about his or her child s PDD.
What the caregiver feels about him- or herself as a caregiver of a child with a PDD.
General questions about the caregiver, his or her family and the child with a PDD.

Detailed Description

This study aims to understand the predictors of adaptation among primary caregivers of children with a pervasive developmental disorder (PDD). PDD presents particular challenges for caregivers because of the communication and socialization challenges of affected children, as well as the uncertainty surrounding the cause, prognosis and recurrence risks. The literature suggests that these challenges may make the process of adapting to having a child with a PDD different than it is for other chronic conditions. This study of caregivers is based on Lazarus and Folkman s Transactional Model of Stress and Coping. A cross-sectional design will be used to investigate the relationships among causal attributions, control perceptions, coping and adaptation. Caregivers will be recruited from support groups, listservs and magazines targeted to autism and other PDDs. Participants will be asked to complete either a web-based or paper survey. The main outcome measure is psychological adaptation to caregiving a child with PDD.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

324Actual

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

Must be 18 or older and the primary caregiver for a child with one of the five diagnosis categorized as a pervasive developmental disorder.

EXCLUSION CRITERIA:

May not be younger than 18 years of age.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barbara B Biesecker	National Human Genome Research Institute (NHGRI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3625467	Background	Affleck G, Tennen H, Pfeiffer C, Fifield J. Appraisals of control and predictability in adapting to a chronic disease. J Pers Soc Psychol. 1987 Aug;53(2):273-9. doi: 10.1037//0022-3514.53.2.273.
3806354	Background	Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173.

ID	Term
D001321	Autistic Disorder
D020817	Asperger Syndrome
D015518	Rett Syndrome
D002659	Child Development Disorders, Pervasive
D000067877	Autism Spectrum Disorder

ID	Term
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D038901	X-Linked Intellectual Disability
D008607	Intellectual Disability