NCT00359775

Brief Summary

Purpose of the study The purpose of this study is to pilot an adapted Coping Skills Training (CST) intervention for feasibility and preliminary efficacy with a sample of children 8 to 12 years of age and their parents. The participants in this study at Children's Hospital of Wisconsin are dealing with one of three chronic health conditions (Rheumatologic Conditions, Epilepsy,Spina Bifida, and Asthma). Research Questions/Study Aims The research questions addressed in the full study are:

  1. 1.What is the impact of CST on child depression, QOL, health motivation, attitude toward illness, and self-management efficacy?
  2. 2.What is the impact of CST on parent depression, perception of child's quality of life, perception of impact of CHC on family, and family conflict?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2006

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

5.5 years

First QC Date

July 31, 2006

Last Update Submit

February 16, 2012

Conditions

Keywords

CopingpsychosocialQuality of Lifeproblem solving

Outcome Measures

Primary Outcomes (4)

  • Child Depression measured by Child Depression Inventory (CDI)

    ongoing

  • Parent Depression measured by Beck Depression inventory (BDI)

    ongoing

  • Quality of life measured by Child Health Questionnaire

    ongoing

  • Impact on Family measured by the Impact of Family Scale.

    ongoing

Interventions

6 session behavioral program

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male and female children ages 8 to 12 with no known severe cognitive delays,
  • Who are English speaking,
  • With one of the three target conditions; and
  • Have at least one parent willing to participate.

You may not qualify if:

  • Children with cognitive delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

EpilepsySpinal DysraphismAsthma

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeural Tube DefectsNervous System MalformationsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Betsy Roth-Wojcicki, MS, CPNP

    Medical College of Wisconsin/Children's Hospital of Wisconsin

    PRINCIPAL INVESTIGATOR
  • Kathleen Sawin, DNS, CPNP,

    University of Wisconsin Milwaukee/Children's Hopsital of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Nurse Practitioner

Study Record Dates

First Submitted

July 31, 2006

First Posted

August 2, 2006

Study Start

July 1, 2006

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations