- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01168284
A Coping Effectiveness Training Intervention for Caregivers of Children With Autism Spectrum: A Feasibility Study
December 14, 2019 updated by: National Human Genome Research Institute (NHGRI)
A Coping Effectiveness Training Intervention for Caregivers of Children With Autism Spectrum Disorders: A Feasibility Study
In recent years, there have been a growing number of individuals diagnosed with Autism Spectrum Disorders (ASD).
As such, this increase has expanded the number of caregivers of children with ASD.
Research has shown that having a child with an ASD is stressful for caregivers and their families.
More specifically, prior research suggests that caregivers of children with ASD may find it difficult to maintain feelings of control and to cope with the overall physical and emotional demands of caring for their child.
A previous study of caregivers of children with ASD found that caregivers felt a lack of personal control over aspects of their child s condition and also found it difficult to cope with various demands of caregiving.
Furthermore, this study found that greater levels of perceived personal control and the use of problem-focused coping strategies were associated with caregivers adaptation to their child s condition.
As such, the goal of our research is to conduct a feasibility study using a coping effectiveness training (CET) intervention designed to enhance perceived personal control (PPC) and coping efficacy in caregivers of children with ASD.
There has been a growing interest in developing interventions targeted at constructs involved in the adaptation process.
However, there have been few studies of interventions targeting predictors of adaptation such as PPC and coping efficacy.
Research has shown that the CET intervention can enhance coping efficacy in several other populations.
This intervention also incorporates appraisals of one s ability to change a particular situation.
The conceptual framework for our study was adapted from Lazarus and Folkman s Transactional Model of Stress and Coping.
A cross-sectional randomized treatment-control design is proposed to evaluate the use of a CET intervention intended to enhance PPC and coping efficacy.
Caregivers of children with ASD will be recruited from support groups, autism resource centers, and four clinics.
Participants randomized to the treatment group will be asked to complete baseline and follow-up surveys and two 1.5-hour individualized in-person sessions.
Participants randomized to the control group will be asked to complete baseline and follow-up surveys and two 1.5-hour individualized in-person client-centered discussion sessions.
The main outcome measures will be participation, reasons for withdrawal, participants experiences within the intervention setting and their experiences in applying the intervention, PPC, coping efficacy, and coping effectiveness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In recent years, there have been a growing number of individuals diagnosed with Autism Spectrum Disorders (ASD).
As such, this increase has expanded the number of caregivers of children with ASD.
Research has shown that having a child with an ASD is stressful for caregivers and their families.
More specifically, prior research suggests that caregivers of children with ASD may find it difficult to maintain feelings of control and to cope with the overall physical and emotional demands of caring for their child.
A previous study of caregivers of children with ASD found that caregivers felt a lack of personal control over aspects of their child s condition and also found it difficult to cope with various demands of caregiving.
Furthermore, this study found that greater levels of perceived personal control and the use of problem-focused coping strategies were associated with caregivers adaptation to their child s condition.
As such, the goal of our research is to conduct a feasibility study using a coping effectiveness training (CET) intervention designed to enhance perceived personal control (PPC) and coping efficacy in caregivers of children with ASD.
There has been a growing interest in developing interventions targeted at constructs involved in the adaptation process.
However, there have been few studies of interventions targeting predictors of adaptation such as PPC and coping efficacy.
Research has shown that the CET intervention can enhance coping efficacy in several other populations.
This intervention also incorporates appraisals of one s ability to change a particular situation.
The conceptual framework for our study was adapted from Lazarus and Folkman s Transactional Model of Stress and Coping.
A cross-sectional randomized treatment-control design is proposed to evaluate the use of a CET intervention intended to enhance PPC and coping efficacy.
Caregivers of children with ASD will be recruited from support groups, autism resource centers, and four clinics.
Participants randomized to the treatment group will be asked to complete baseline and follow-up surveys and two 1.5-hour individualized in-person sessions.
Participants randomized to the control group will be asked to complete baseline and follow-up surveys and two 1.5-hour individualized in-person client-centered discussion sessions.
The main outcome measures will be participation, reasons for withdrawal, participants experiences within the intervention setting and their experiences in applying the intervention, PPC, coping efficacy, and coping effectiveness.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Kennedy Krieger Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- INCLUSION CRITERIA:
- Must be a primary caregiver (biological or adoptive parent or grandparent) of a child with an ASD [note: no restrictions with regard to age of the child or how recently s/he was diagnosed
- Must be at least 18 years of age
- Caregivers must reside with the child
- Only one caregiver per household and this person should be the caregiver that spends the most time with the child.
- Must be able to read, write, and speak English
EXCLUSION CRITERIA:
- Those who have a child with any specific genetic diagnosis associated with ASD [including Rett, Tuberous Sclerosis Complex, Fragile X Syndrome, Neurofibromatosis, Prader-Willi Syndrome, and Angelman Syndrome will not be eligible to participate in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Feasibility of the intervention
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Astin JA, Beckner W, Soeken K, Hochberg MC, Berman B. Psychological interventions for rheumatoid arthritis: a meta-analysis of randomized controlled trials. Arthritis Rheum. 2002 Jun 15;47(3):291-302. doi: 10.1002/art.10416.
- Chesney MA, Neilands TB, Chambers DB, Taylor JM, Folkman S. A validity and reliability study of the coping self-efficacy scale. Br J Health Psychol. 2006 Sep;11(Pt 3):421-37. doi: 10.1348/135910705X53155.
- Hall S, Reid E, Ukoumunne OC, Weinman J, Marteau TM. Brief smoking cessation advice from practice nurses during routine cervical smear tests appointments: a cluster randomised controlled trial assessing feasibility, acceptability and potential effectiveness. Br J Cancer. 2007 Apr 10;96(7):1057-61. doi: 10.1038/sj.bjc.6603684.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 5, 2010
Primary Completion (Actual)
April 4, 2011
Study Completion (Actual)
May 6, 2011
Study Registration Dates
First Submitted
July 22, 2010
First Submitted That Met QC Criteria
July 22, 2010
First Posted (Estimate)
July 23, 2010
Study Record Updates
Last Update Posted (Actual)
December 17, 2019
Last Update Submitted That Met QC Criteria
December 14, 2019
Last Verified
November 21, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999910160
- 10-HG-N160
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorders
-
Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
-
Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
Emory UniversityNational Institute of Mental Health (NIMH)Terminated
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Florida State University; Autism...CompletedAutism Spectrum DisordersUnited States
-
University Hospital, MontpellierCaisse Nationale de Solidarité pour l'AutonomieActive, not recruitingAutism Spectrum DisordersFrance
-
Institut National de la Santé Et de la Recherche...Completed
-
Linmarie SikichEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedAutism Spectrum DisordersUnited States
-
University of California, San DiegoCompletedAutism Spectrum DisordersUnited States
-
Stanford UniversityNational Institute of Mental Health (NIMH)Completed
-
Syracuse UniversityTexas Woman's UniversityCompleted
Clinical Trials on Coping Effectiveness Training
-
Karolinska InstitutetSwedish Red Cross University CollegeCompleted
-
University of California, San FranciscoNational Institute of Mental Health (NIMH)CompletedHIV InfectionsUnited States
-
Research Foundation for Mental Hygiene, Inc.Columbia UniversityWithdrawn
-
Oregon Health and Science UniversityUniversity of GeorgiaActive, not recruitingHIV SeropositivityUnited States
-
VA Office of Research and DevelopmentCompletedTinnitusUnited States
-
Ohio UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...CompletedCardiorespiratory FailureUnited States
-
Duke UniversityCompletedHematopoietic Neoplasms (Leukemia, Lymphoma, Multiple Myeloma)United States
-
Children's Hospital and Health System Foundation...University of Wisconsin, MadisonCompletedEpilepsy | Asthma | Spina Bifida | Rheumatologic Conditions (JRA,Lupus)United States
-
Fundació Institut de Recerca de l'Hospital de la...CompletedMindfulness Skills | Interpersonal Effectiveness SkillsSpain