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Wonders & Worries: A Clinical Trial of a Psychosocial Intervention for Children Who Have a Parent With Cancer

NCT02758639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-10-10

No results posted yet for this study

Summary

Parental cancer can cause substantial behavioral and emotional distress in both parent and child. Parents struggle with talking with their child about their cancer and supporting the child during treatment. Over 73% of patients with children desire information and services to support their children yet only 9% of these families report receiving this support. The purpose of this study is to evaluate the Wonders \& Worries psychosocial intervention designed for children ages 5-14 who have a parent diagnosed with early stage cancer.This study is a randomized controlled clinical trial (RCT) evaluating the Wonders \& Worries group and individual intervention for school age children (5 -14 years old) who have a parent with cancer. Families will be enrolled at the time of initial parent consultation, given informed consent, and then randomized either to the intervention group of 30 families or the wait-listed control group of 30 families. Both groups will be given a series of standardized validated assessment instruments including the Revised Children's Manifest Anxiety Scale (RCMAS), the Child Behavior Checklist (CBCL), and the Family Communication Scale FACES IV at baseline, post intervention, and 8 week follow up. Upon completion of the follow up measures, families in the wait-listed control group will be enrolled into the intervention. Parent exit interviews for both groups will be used to measure parent-reported child outcomes and program utility.

Conditions

  • Cancer
  • Psychological Adjustment

Interventions

BEHAVIORAL

Wonders & Worries Psychosocial Intervention

Session 1: Getting to Know Each Other The goal is to create a sense of safety within the group so that the children feel comfortable discussing difficult topics. Session 2: Cancer Education to provide developmentally appropriate education about the illness, treatment, and side effects. Session 3: Cancer Treatment Center Tour: This session consists of a treatment center tour and education about treatment plan involved in family's care in a safe environment. Session 4: Feelings: The focus of this session is expression and validation of all feelings the children may experience. Session 5: Stress and Coping: Goal is to emphasize the different ways individuals cope and differentiate positive vs. negative coping strategies. Session 6: Hopes for the Future/Closure: An emphasis is made on the idea that positive things may evolve from the most difficult circumstances.

Sponsors & Collaborators

  • Wonders & Worries

    collaborator UNKNOWN

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Farya Phillips, PhD · University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-08-19
Completion
2018-08-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02758639 on ClinicalTrials.gov