Wonders & Worries: A Clinical Trial of a Psychosocial Intervention for Children Who Have a Parent With Cancer
Condition: Cancer; Psychological Adjustment
Study type: Interventional

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.
    

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.
    

Intervention name(s): Wonders & Worries Psychosocial Intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: parental cancer; children psychosocial adjustment; psychosocial intervention