Online Problem Solving Skills Training

Childhood Cancer Clinical Trial

Official title:

Online Implementation of Problem Solving Skills Training for Mothers of Newly Diagnosed Childhood Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711944
• Other study ID #: 1R01CA159013-01A1
• Secondary ID: R01CA159013-01A1
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: April 30, 2019

Study information

• Verified date: July 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Parents of children newly diagnosed with cancer experience depression and anxiety, especially in the first several months of treatment. Bright IDEAS, an 8-session problem-solving skills training (PSST) program has been used in studies with more than 900 mothers including more than 125 monolingual Spanish-speaking mothers. It has been shown to significantly decrease mothers' distress and to particularly benefit Latina immigrants. This past spring, the NCI/NIH designated Bright IDEAS as a Research-Tested Intervention Program and has included it in the National Registry of Evidence-based Programs and Practices. To date, Bright IDEAS has been available to mothers at only a few cancer centers with specially trained personnel. This proposal is designed to bring Bright IDEAS on-line to make it available to mothers and fathers 24/7 anywhere with Internet access. The investigators will carefully analyze acceptability and use to gain insight into the most promising ways of disseminating interventions like Bright IDEAS using Internet, Internet II, and other emerging technologies.

Description:

Research and experience document that caregivers of children with cancer encounter extraordinary stresses during the child's illness. These stresses are particularly severe during diagnosis and early therapy and can interfere significantly with a caregiver's ability to make reasoned and timely decisions on their child's behalf. With increasing survivor rates, it has become evident that decisions made in the early stages of cancer management can have profound long-term effects, adding to the distress caregivers feel trying to make the "right" decisions. Too help mothers of newly diagnosed children cope more effectively with these challenges, the investigators conducted randomized controlled trials (R25CA65520, R01CA098954) to develop, field test, and evaluate the efficacy of the Bright IDEAS paradigm of problem-solving skills training (PSST), a cognitive-behavioral therapy shown to decrease anxiety and depression - two symptoms of post-traumatic stress commonly experienced among this group of mothers. Our findings clearly show that PSST significantly increases problem-solving skills (primary effect) and decreases negative affectivity (secondary effect) in mothers from a variety of racial, ethnic, and socioeconomic backgrounds. Particularly powerful and long-lasting effects were noted in Spanish-speaking mothers, an especially underserved population. In March 2010, the NCI designated Bright IDEAS as a Research-based Therapy/Intervention Program (RTIP) and entered it into the National Registry of Evidence-based Programs and Practices (NREPP). As an 8-session, in-person intervention, Bright IDEAS is labor intensive and, to date, has only been available at a few institutions with trained personnel. However, as a part of the RTIPs evaluation process, the Dissemination Capability of Bright IDEAS was rated 5/5. This proposal is designed to meet the challenge inherent in this perfect score. The investigators will also immediately broaden the scope of users by including fathers as eligible participants in this study of a new delivery paradigm the investigators believe they will find appealing. Aim 1 is implementation of an engaging, easy-to-use on-line version of Bright IDEAS that would be available 24/7 to any person anywhere who has access to the Internet. Aim 2 is the use of "Diffusion of Innovations" theory to craft a framework for disseminating not only Bright IDEAS but other similar interventions with the greatest effectiveness and efficiency. In past studies, the investigators have shown that the human element (time and attention) inherent in in-person interventions is effective in bringing immediate relief of distress but not sufficient to maintain its benefits over time. In contrast, mothers receiving PSST increase their skills and continue to improve their sense of well-being 3 months after the intervention. What the investigators have not investigated is whether a computer-based intervention is as effective as (not inferior to) an in-person intervention. The results will have significant implications for future dissemination strategies, especially the use of Internet II and other emerging technologies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 629
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Subjects will be drawn from the pool of all parents who are primary caregivers of children diagnosed with any form of cancer 4-16 weeks prior to contact about the Problem Solving Skills Training intervention and cared for at one of the 4 data collection sites. No attempt will be made to stratify the sample by any particular demographic variables (e.g., age, ethnic background, or type of cancer diagnosed in their child), except that monolingual Spanish-speaking parents will be specifically recruited to provide adequate representation for statistical analysis at Childrens Hospital Los Angeles and UT/MD Anderson Cancer Center. Goal: 20% total enrollment.

Exclusion Criteria: Parents of children with cancer will be excluded if (1) they do not read or speak English or Spanish; (2) their child is in severe a medical crisis, as determined by the oncologist, or (3) they live a prohibitive distance to complete the intervention (typically, >50 miles from the Center) and do not have access to a telephone for phone intervention sessions. Internet access will be facilitated as part of the e-PSST intervention arm. These exclusionary criteria are identical to our previous work; <10% of eligible mothers have been excluded.

Related Conditions & MeSH terms

• Childhood Cancer

Intervention

Behavioral:
• Problem-Solving Skills Training
8-session manualized intervention to provide problem-solving skills training in the context of childhood cancer.

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas
United States	University of Texas/MD Anderson Cancer Center	Houston	Texas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (9)

Lead Sponsor	Collaborator
University of Rochester	Children's Hospital Los Angeles, M.D. Anderson Cancer Center, National Institutes of Health (NIH), Rutgers Cancer Institute of New Jersey, St. Jude Children's Research Hospital, University of Colorado, Denver, University of Pittsburgh, University of Texas, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of Event Scale-Revised	This is a well-validated assessment of the impact of a specified event (in this case, the diagnosis of cancer in a child)	Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)
Other	Bidimensional Acculturation Scale for Hispanics	This is a well-validated measure of the degree to which an individual born in another country has adopted the customs of their new country	Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)
Other	Hispanic Stress Inventory	This is a well validated assessment of the social, financial, and emotional ramifications associated with being a minority individual (in this case, Hispanic).	Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)
Other	Current Problems Inventory	The Current Problems Inventory was developed by the investigators to provide examples of the kinds of problems commonly encountered in families with a child with cancer. This form has been completed by participants at T1 in all studies of Bright IDEAS PSST to date. During this project, the CPI will be given at T1, T2, and T3 to monitor change over time.	Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)
Other	Demographic Information	Includes information about the child with cancer (age, diagnosis, date of diagnosis), parental age, marital status, educational level, occupational prestige of the family, and previous experience with the Internet.	Baseline (T1)
Other	Impact of Event Scale-Revised (IES-R)	A 22-item self-report measuring perceived post-traumatic stress, includes three subscales (intrusion, avoidance, and hyperarousal) that assess PTS symptoms (PTSSx) during the past week experienced in response to a specific event. Widely used to measure PTSSx associated with events such as diagnosis with cancer. Internal consistency reliabilities of the intrusion, avoidance, and hyperarousal subscales are .91, .84, and .90, respectively.	Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)
Other	Credibility/Expectancy	Credibility is measured along four dimensions and expectancy is rated on a scale of 0 to 100. These rating scales were developed by the investigators specifically for this purpose and used in our most recent previous study.	After the first face-to-face PSST or ePSST session and after the fourth face-to-face PSST session or four weeks after the first ePSST session
Other	User Satisfaction	Will be assessed using a 21-item questionnaire developed by the investigators to address intervention-specific and website-specific issues. Only the first five questions and the open-ended questions modified for the face-to-face group (specific to Bright IDEAS itself) will be completed by participants receiving the standard intervention. The questionnaire will be administered at T2.	Post intervention (3 months; T2)
Primary	Social Problem Solving Skills Inventory	This is a well validated assessment of problem-solving strategies and positive or negative orientation to problem solving.	Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)
Secondary	Profile of Mood States	This is a well validated measure of depression and anxiety	Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)
Secondary	Patient Health Questionnaire (PHQ9)	A 9-item self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ9 is the depression module which rates each of the nine DSM-IV criteria as 0 (not at all) to 3 (nearly every day). It will be used in place of the Beck Depression Inventory.	Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)