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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Psychological Adjustment
• Intervention / Treatment: Behavioral: Wonders & Worries Psychosocial Intervention

Detailed Description

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. The Wonders & Worries program curriculum is a psychosocial intervention that was designed to address the communication and distress issues raised in prior descriptive research and to respond to the limitations of current research. The goals of the program are to improve children's behavioral-emotional adjustment to their parent's cancer, improve parenting behavior (parenting quality, skills and self-efficacy), and increase family communication about the illness. The aim of the current study is to evaluate the efficacy of the Wonders & Worries program on child and parent outcomes within a randomized clinical trial.

Wonders & Worries is an Austin based non-profit agency. Wonders & Worries works with families in all stages of survivorship, who are affected by any serious or chronic physical illness.

The fully scripted intervention involves 6 group or individual sessions for the children, each of which is briefly summarized, in Table 1. Families will be enrolled at the time of initial parent consultation at Wonders & Worries, 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), the Family Communication Scale FACES IV, and the AMMI-EC3- About My Mommy's Illness 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.

The intervention will be provided by Wonders & Worries certified child life specialists. Child life specialists are professionals trained to help children and their families understand and manage challenging life events and stressful health care experiences. By using play, recreation, education, self-expression and theories of child development, these specialists help promote the psychological well-being and optimum development of children and families faced with stressful situations. At Wonders & Worries all services are provided by master's prepared certified child life specialists.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Families with children ages 5-14 at time of study. Children have a parent with early stage cancer, and are English-speaking.

Exclusion Criteria:

• Children are not living in the home with the ill parent at least 50% of the time. Non-English speaking families.

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: W & W Intervention; Wonders & Worries Psychosocial intervention is a 6 week group or individual sessions for children who have a parent with cancer focusing on psycho-educational information about cancer, treatment and its side effects, feelings expression, positive coping strategies, and family communication about the illness.	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.
Other: Wait list control; Wait list group will complete baseline, 6 week and 8 week follow up measures and then will be enrolled to receive W & W intervention.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Child's Anxiety level (RCMAS) from baseline to 6 weeks and 8 week follow up	Revised Children's Manifest Anxiety Scale - child self report	Baseline, 6 week, 8 week follow up
Change in Child's Emotional/Behavioral Status (CBCL) from baseline to 6 weeks and 8 week follow up	Child Behavior Checklist - parent report	Baseline, 6 week, 8 week follow up
Change in Family Communication Scale FACES IV from baseline to 6 weeks and 8 week follow up	parent & child report	Baseline, 6 week, 8 week follow up
Change in The Family Quality of Life Scale (FQOL) from baseline to 6 weeks and 8 week follow up	parent & child report	Baseline, 6 week, 8 week follow up
Change in Cancer Self-Efficacy Scale (CASE) from baseline to 6 weeks and 8 week follow up	parent report of parenting self efficacy	Baseline, 6 week, 8 week follow up
Change in Spielberger State-Trait Anxiety Inventory (STAI) from baseline to 6 weeks and 8 week follow up	parent self report of anxiety	Baseline, 6 week, 8 week follow up
Change in Depression scale (CES-D) from baseline to 6 weeks and 8 week follow up	parent self report of depression	Baseline, 6 week, 8 week follow up
Change in Parenting Concerns Questionnaire (PCQ) for adults with cancer from baseline to 6 weeks and 8 week follow up	parent self report	Baseline, 6 week, 8 week follow up
Change in child's worries about their parent's illness from baseline to 6 weeks and 8 week follow up	child self report of worries related to parent's illness AMMI-EC3- About My Mommy's Illness	Baseline, 6 week, 8 week follow up

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: Wonders & Worries
• Investigators: Principal Investigator: Farya Phillips, PhD, University of Texas at Austin

Publications and helpful links

General Publications

• Phillips F, Prezio EA. Wonders & Worries: evaluation of a child centered psychosocial intervention for families who have a parent/primary caregiver with cancer. Psychooncology. 2017 Jul;26(7):1006-1012. doi: 10.1002/pon.4120. Epub 2016 Mar 8.
• Phillips F, Prezio EA, Currin-McCulloch J, Jones BL. Wonders & Worries: A randomized clinical trial of a psychosocial intervention for children who have a parent with cancer. Psychooncology. 2022 Aug;31(8):1399-1411. doi: 10.1002/pon.5943. Epub 2022 Apr 29.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): August 19, 2018
• Study Completion (Actual): August 19, 2018

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: psychosocial intervention; parental cancer; children psychosocial adjustment
• Other Study ID Numbers: 201502573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No