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Behavioral Intervention

eHealth Psychosocial Intervention for Parents of Children with Pediatric Cancer

N/A

Recruiting

Research Sponsored by Nemours Children's Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be the parent or primary caregiver of a child (ages 0 - 18 years old) diagnosed with cancer

Participants must be able to speak and read English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 20 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an eHealth intervention to help parents and caregivers of children with cancer deal with the psychological risks associated with the disease. The goal is to improve coping abilities and decrease negative psychological effects.

Who is the study for?

This trial is for English or Spanish speaking parents or primary caregivers of children (ages 0-18) diagnosed with cancer. They must have internet access via a computer or mobile device. Parents whose child may not survive beyond six months are excluded.

What is being tested?

The study tests eSCCIP/eSCCIP-SP, an online psychosocial support program aimed at reducing distress, posttraumatic stress, and anxiety among parents while enhancing coping skills during their child's cancer treatment.

What are the potential side effects?

As this is a psychosocial intervention focused on providing emotional support through digital means, there are no direct physical side effects like those associated with medication. However, participants may experience varying levels of emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am the main caregiver for a child with cancer.

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I can speak and read either English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

K-6

Secondary study objectives

Cognitive Emotion Regulation Questionnaire

Coping Self-Efficacy Scale

Distress Thermometer

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Coping SpaceActive Control1 Intervention

PCCC randomized to the patient education control condition will be given access to a website with information about psychosocial functioning, coping, and PTSS related to pediatric cancer. This website will be hosted on the same platform as the intervention, available in English and Spanish, and will consist of information modified from CopingSpace.org. CopingSpace.org is an evidence-informed website developed by Ryan's Case for Smiles, a national organization dedicated to supporting families impacted by pediatric cancer and other chronic diseases.

Group II: eSCCIP/eSCCIP-SPActive Control1 Intervention

The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative eHealth intervention that combines cognitive behavioral and family systems therapy to provide parents and caregivers of children with cancer (PCCC) with evidence-based coping skills and psychosocial support focused on the family unit. eSCCIP has three 30-minute, self-directed, online modules which feature a unique mix of original video content and interactive activities, supplemented by three telehealth follow-up sessions. A stakeholder-informed Spanish-language adaption of eSCCIP (eSCCIP-SP) has been developed and will be offered to Spanish-speaking PCCC. eSCCIP aims to reduce acute distress and symptoms of post-traumatic stress while increasing positive coping self-appraisal and use of cognitive coping skills.

0 / 2Eligibility criteria met