Childhood Chronic Illness: An Educational Program for Parents of Children With On-Going Health Care Needs
Primary Purpose
Chronic Illness
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
7 week Building on Family Strengths Program
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Illness focused on measuring children, chronic illness, parent education, parent support
Eligibility Criteria
Inclusion Criteria: Child 2-11 years of age, with diagnosed chronic illness Parent at least 18 years of age, able to speak and read English at 4th grade level and able to attend a 7 week two-hour class program Exclusion Criteria: Child in active hospice treatment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
0
Arm Description
Outcomes
Primary Outcome Measures
depressive symptoms
Secondary Outcome Measures
self-efficacy
parent-child shared management
coping
quality of life
Full Information
NCT ID
NCT00194584
First Posted
September 13, 2005
Last Updated
September 25, 2008
Sponsor
University of Washington
Collaborators
Seattle Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00194584
Brief Title
Childhood Chronic Illness: An Educational Program for Parents of Children With On-Going Health Care Needs
Official Title
Building on Family Strengths: An Educational Program for Parents of Children With On-Going Health Care Needs
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Washington
Collaborators
Seattle Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The long-term goal of this research is to strengthen parents' abilities to manage the complexities of childhood chronic illness. To achieve this goal, the team of parents, health care professionals, and researchers proposes the following specific aim:
Develop, implement, and test a unique psycho-educational program, Living with Childhood Chronic Illness (the Program), for effectiveness with parents of children who have chronic illnesses.
The investigators propose the following hypotheses:
At both 6 and 12 month follow-up points, parents taking part in the intervention, in contrast to control parents, will have:
Greater perceived self-efficacy regarding their ability to manage the child's chronic condition;
Greater parental ability to involve their child in shared management activities;
Greater parental ability to cope at 6 and 12 months following the end of the intervention;
Greater emotional health; and
Greater parental perceived family quality of life.
Detailed Description
Parents will enroll in the study by contacting the study number: 206-987-1000 or by sending an email message to family.strengths@seattlechildrens.org. They will complete a survey taking no more than 60 minutes. Parents will then be randomized to either take the class immediately or be in the control group which can take the class in 12 months. At the end of 6 and 12 months all the participants again take the survey.
Classes are 7 weeks in length, 2 hours each and are offered at various locations throughout the Greater Seattle area.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Illness
Keywords
children, chronic illness, parent education, parent support
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
0
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
7 week Building on Family Strengths Program
Intervention Description
Parents in intervention group attend a 2 hr class for seven weeks. These classes provide information, time for discussion and creation of an action plan for the parent to complete in the intervening week.
Primary Outcome Measure Information:
Title
depressive symptoms
Time Frame
6, and 12 months
Secondary Outcome Measure Information:
Title
self-efficacy
Time Frame
6 and 12 months
Title
parent-child shared management
Time Frame
6, and 12 months
Title
coping
Time Frame
6, and 12 months
Title
quality of life
Time Frame
6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Child 2-11 years of age, with diagnosed chronic illness
Parent at least 18 years of age, able to speak and read English at 4th grade level and able to attend a 7 week two-hour class program
Exclusion Criteria:
Child in active hospice treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail M Kieckhefer, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Childhood Chronic Illness: An Educational Program for Parents of Children With On-Going Health Care Needs
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