Enhancing Connections: Helping the Mother With Breast Cancer Support Her Child (EC R01)
Recruitment status was Active, not recruiting
This is a 6-state randomized controlled trial (RCT) that uses a behavioral intervention to enhance parenting skills for school age children when a mother is recently diagnosed with early stage breast cancer. Efficacy analyses will include measures of the child's and mother's psychosocial adjustment, including enhanced parenting quality and skills related to the cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Helping the Mother With Breast Cancer Support Her Child|
- Increased parenting skills and confidence by diagnosed mothers [ Time Frame: 1-year ] [ Designated as safety issue: No ]
- Decreased anxiety and depressed mood in diagnosed mothers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||June 1999|
|Estimated Study Completion Date:||May 2009|
|Estimated Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Behavioral: Educational counseling intervention
This is a Phase 3 randomized clinical trial of recently diagnosed mothers with local or regional breast cancer and their school age child. After baseline measures are taken, mothers are randomized into either intervention and control group. Intervention participants are given 5, 1-hour at home educational counseling sessions by a specially trained nurse. Control participants are mailed an educational booklet whose content focuses on supportive parenting behaviors that are part of the face to face sessions given to the experimental group.
The theoretical framework for the study derives from Bandura's Social Cognitive Theory, a contextual model of parenting, and stress and coping theory. Efficacy is evaluated through standardized valid and reliable questionnaires of psychosocial functioning in the mother (affect, mood, self-efficacy) and psychosocial functioning in the child (cognitive-emotional functioning, including behavioral problems, anxiety, depressed mood, and cancer-related concerns). Primary study hypotheses will be evaluated comparing pre-posttest measures of the intervention compared to controls at post-test and 1-year follow up.
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Frances M Lewis, PhD||University of Washington|