AutismNCT00496210
Predictors of Caregiver Adaptation to Pervasive Developmental Disorders
An observational study of Autism and Asperger's Syndrome, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism, Asperger's Syndrome, Rett's Disorder
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2007to 7 Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 or older and the primary caregiver for a child with one of the five diagnosis categorized as a pervasive developmental disorder.
Who cannot join
- May not be younger than 18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Understanding Caregiver Adaptation to Pervasive Developmental Disorders
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.
Read the 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.
- Conditions
- Autism, Asperger's Syndrome, Rett's Disorder
- Keywords
- Adaptation, Pervasive Developmental Disorder, Autism Spectrum Disorders, Pervasive Developmental Disorders, Caregiver Adaptation
- Medical subject headings
- Autistic Disorder, Asperger Syndrome, Rett Syndrome, Child Development Disorders, Pervasive, Autism Spectrum Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study start27 Jun 2007
- Study completion7 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Barbara B Biesecker, Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496210
- Sponsor's protocol ID
- 999907178
- Other IDs
- 07-HG-N178
- Status last verified
- 7 Dec 2015
- First submitted
- 3 Jul 2007
- Last updated
- 15 Nov 2019
- Results posted
- No
Publications
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.
PubMed 3625467Baron 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.
PubMed 3806354Aldwin CM, Revenson TA. Does coping help? A reexamination of the relation between coping and mental health. J Pers Soc Psychol. 1987 Aug;53(2):337-48. doi: 10.1037//0022-3514.53.2.337.
PubMed 3625471
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Caregiver Adaptation to Pervasive Developmental Disorders
- ClinicalTrials.gov ID
- NCT00496210
- Acronym / sponsor ID
- 999907178
- Conditions
- Autism, Asperger's Syndrome, Rett's Disorder
- Keywords
- Adaptation, Pervasive Developmental Disorder, Autism Spectrum Disorders, Pervasive Developmental Disorders, Caregiver Adaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 27 Jun 2007
- Study completion
- 7 Dec 2015
- First posted
- 4 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be 18 or older and the primary caregiver for a child with one of the five diagnosis categorized as a pervasive developmental disorder.
Key exclusion criteria (1 listed)
- May not be younger than 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Background: PubMed 3625467Affleck 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.
- Background: PubMed 3806354Baron 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.
- Background: PubMed 3625471Aldwin CM, Revenson TA. Does coping help? A reexamination of the relation between coping and mental health. J Pers Soc Psychol. 1987 Aug;53(2):337-48. doi: 10.1037//0022-3514.53.2.337.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara B Biesecker principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Asperger's Syndrome, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Nov 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00496210, which also lists 3 linked publications.
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 15 Nov 2019.