A Coping Effectiveness Training Intervention for Caregivers of Children With Autism Spectrum: A Feasibility Study
Primary Purpose
Autism Spectrum Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coping Effectiveness Training
Sponsored by
About this trial
This is an interventional other trial for Autism Spectrum Disorders focused on measuring Autism Spectrum Disorders
Eligibility Criteria
- 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.
Sites / Locations
- Kennedy Krieger Institute
Outcomes
Primary Outcome Measures
Feasibility of the intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT01168284
First Posted
July 22, 2010
Last Updated
December 14, 2019
Sponsor
National Human Genome Research Institute (NHGRI)
1. Study Identification
Unique Protocol Identification Number
NCT01168284
Brief Title
A Coping Effectiveness Training Intervention for Caregivers of Children With Autism Spectrum: A Feasibility Study
Official Title
A Coping Effectiveness Training Intervention for Caregivers of Children With Autism Spectrum Disorders: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 21, 2016
Overall Recruitment Status
Completed
Study Start Date
July 5, 2010 (undefined)
Primary Completion Date
April 4, 2011 (Actual)
Study Completion Date
May 6, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Human Genome Research Institute (NHGRI)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
Autism Spectrum Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Coping Effectiveness Training
Primary Outcome Measure Information:
Title
Feasibility of the intervention
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara B Biesecker
Organizational Affiliation
National Human Genome Research Institute (NHGRI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12115160
Citation
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.
Results Reference
background
PubMed Identifier
16870053
Citation
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.
Results Reference
background
PubMed Identifier
17406348
Citation
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.
Results Reference
background
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A Coping Effectiveness Training Intervention for Caregivers of Children With Autism Spectrum: A Feasibility Study
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