Childhood Chronic Illness: An Educational Program for Parents of Children With On-Going Health Care Needs

September 25, 2008 updated by: University of Washington

Building on Family Strengths: An Educational Program for Parents of Children With On-Going Health Care Needs

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:

  1. Greater perceived self-efficacy regarding their ability to manage the child's chronic condition;
  2. Greater parental ability to involve their child in shared management activities;
  3. Greater parental ability to cope at 6 and 12 months following the end of the intervention;
  4. Greater emotional health; and
  5. Greater parental perceived family quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Behavioral: 7 week Building on Family Strengths Program
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.
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
depressive symptoms
Time Frame: 6, and 12 months
6, and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
self-efficacy
Time Frame: 6 and 12 months
6 and 12 months
parent-child shared management
Time Frame: 6, and 12 months
6, and 12 months
coping
Time Frame: 6, and 12 months
6, and 12 months
quality of life
Time Frame: 6, and 12 months
6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Seattle Children's Hospital

Investigators

  • Principal Investigator: Gail M Kieckhefer, PhD, University of Washington

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

October 1, 2004

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

September 29, 2008

Last Update Submitted That Met QC Criteria

September 25, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-0564-01
  • 1R01HS013384-04 (U.S. AHRQ Grant/Contract)

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.

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