Online Problem Solving Skills Training

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

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.

Study Overview

• Status: Completed
• Conditions: Childhood Cancer
• Intervention / Treatment: Behavioral: Problem-Solving Skills Training

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 629
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027-6016
      • Children's Hospital Los Angeles
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Children's Hospital of Pittsburgh
  • Tennessee
    • Memphis, Tennessee, United States, 38105-3678
      • St. Jude Children's Research Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
    • Houston, Texas, United States, 77030
      • University of Texas/MD Anderson Cancer Center

Participation Criteria

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: 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online PSST; An online version of Problem-Solving Skills Training (PSST) will be compared to standard (face-to-face) PSST	Behavioral: Problem-Solving Skills Training; 8-session manualized intervention to provide problem-solving skills training in the context of childhood cancer.; Other Names: PSST; Bright IDEAS; Online PSST; Standard or face-to-face PSST
Active Comparator: Face-to-Face PSST; This is an 8-session face-to-face Problem-Solving Skills Training intervention	Behavioral: Problem-Solving Skills Training; 8-session manualized intervention to provide problem-solving skills training in the context of childhood cancer.; Other Names: PSST; Bright IDEAS; Online PSST; Standard or face-to-face PSST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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
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)

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: M.D. Anderson Cancer Center; University of Colorado, Denver; University of Pittsburgh; National Institutes of Health (NIH); St. Jude Children's Research Hospital; Children's Hospital Los Angeles; Rutgers Cancer Institute of New Jersey; University of Texas, El Paso
• Investigators: Principal Investigator: Olle Jane Z Sahler, MD, University of Rochester

Publications and helpful links

General Publications

• Phipps S, Fairclough DL, Noll RB, Devine KA, Dolgin MJ, Schepers SA, Askins MA, Schneider NM, Ingman K, Voll M, Katz ER, McLaughlin J, Sahler OJZ. In-person vs. web-based administration of a problem-solving skills intervention for parents of children with cancer: Report of a randomized noninferiority trial. EClinicalMedicine. 2020 Jun 27;24:100428. doi: 10.1016/j.eclinm.2020.100428. eCollection 2020 Jul.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: September 29, 2012
• First Submitted That Met QC Criteria: October 18, 2012
• First Posted (Estimate): October 22, 2012

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: caregivers; parents; childhood cancer; problem solving; Internet communication
• Other Study ID Numbers: 1R01CA159013-01A1 (U.S. NIH Grant/Contract); R01CA159013-01A1 (U.S. NIH Grant/Contract)