Chronic IllnessNCT00194584
Childhood Chronic Illness: An Educational Program for Parents of Children With On-Going Health Care Needs
A study testing 7 week Building on Family Strengths Program in people with Chronic Illness, run by University of Washington.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Illness
- What is being tested?
- 7 week Building on Family Strengths Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Feb 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Child in active hospice treatment
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Chronic Illness
- Being tested
- 7 week Building on Family Strengths Program
- Keywords
- children, chronic illness, parent education, parent support
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 week Building on Family Strengths ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: 7 week Building on Family Strengths Program |
| 0 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
depressive symptoms
Measured: 6, and 12 months
Secondary outcomes (4)
self-efficacy
Measured: 6 and 12 months
parent-child shared management
Measured: 6, and 12 months
coping
Measured: 6, and 12 months
quality of life
Measured: 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startOct 2004
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital
- Investigators
- Gail M Kieckhefer, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194584
- Sponsor's protocol ID
- 04-0564-01
- Other IDs
- 1R01HS013384-04
- Status last verified
- Sep 2008
- First submitted
- 13 Sep 2005
- Last updated
- 29 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building on Family Strengths: An Educational Program for Parents of Children With On-Going Health Care Needs
- ClinicalTrials.gov ID
- NCT00194584
- Acronym / sponsor ID
- 04-0564-01
- Conditions
- Chronic Illness
- Keywords
- children, chronic illness, parent education, parent support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital
- Study start
- Oct 2004
- Study completion
- Feb 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: 7 week Building on Family Strengths Program |
| 0 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Child in active hospice treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7 week Building on Family Strengths ProgramParents 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. | Behavioural | 1 |
Primary outcome
depressive symptoms
Time frame: 6, and 12 months
4 secondary outcomes
self-efficacy
Time frame: 6 and 12 months
parent-child shared management
Time frame: 6, and 12 months
coping
Time frame: 6, and 12 months
quality of life
Time frame: 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2008.
- Website that directs parents to registration for research projectLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail M Kieckhefer, PhD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing 7 week Building on Family Strengths Program in people with Chronic Illness, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depressive symptoms (time frame: 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2008.