NCT01711944

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
629

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 22, 2012

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

6.8 years

First QC Date

September 29, 2012

Last Update Submit

July 9, 2019

Conditions

Childhood Cancer

Keywords

childhood cancerInternet communicationparentscaregiversproblem solving

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Profile of Mood States

    Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)

  • Patient Health Questionnaire (PHQ9)

    Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)

Other Outcomes (8)

  • Impact of Event Scale-Revised

    Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)

  • Bidimensional Acculturation Scale for Hispanics

    Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)

  • Hispanic Stress Inventory

    Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)

  • +5 more other outcomes

Study Arms (2)

Online PSST

EXPERIMENTAL

An online version of Problem-Solving Skills Training (PSST) will be compared to standard (face-to-face) PSST

Behavioral: Problem-Solving Skills Training

Face-to-Face PSST

ACTIVE COMPARATOR

This is an 8-session face-to-face Problem-Solving Skills Training intervention

Behavioral: Problem-Solving Skills Training

Interventions

Problem-Solving Skills TrainingBEHAVIORAL

8-session manualized intervention to provide problem-solving skills training in the context of childhood cancer.

Also known as: PSST, Bright IDEAS, Online PSST, Standard or face-to-face PSST
Face-to-Face PSSTOnline PSST

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Children's Hospital Los Angeles

Los Angeles, California, 90027-6016, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-3678, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

University of Texas/MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 32637901DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Olle Jane Z Sahler, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 29, 2012

First Posted

October 22, 2012

Study Start

July 1, 2012

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations

US(6)