NCT01168284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2011

Completed
Last Updated

December 17, 2019

Status Verified

November 21, 2016

Enrollment Period

9 months

First QC Date

July 22, 2010

Last Update Submit

December 14, 2019

Conditions

Keywords

Autism Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the intervention

    2 months

Interventions

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

  • 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.

    PMID: 12115160BACKGROUND
  • 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.

    PMID: 16870053BACKGROUND
  • 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.

    PMID: 17406348BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Barbara B Biesecker

    National Human Genome Research Institute (NHGRI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 23, 2010

Study Start

July 5, 2010

Primary Completion

April 4, 2011

Study Completion

May 6, 2011

Last Updated

December 17, 2019

Record last verified: 2016-11-21

Locations