SibACCESS: Developing a Telehealth Intervention to Address Unmet Psychosocial Needs of Siblings of Children With Cancer

Posttraumatic Stress Disorder Clinical Trial

— R03 CA259898  

Official title:

SibACCESS: Developing a Telehealth Intervention to Address Unmet Psychosocial Needs of Siblings of Children With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889755
• Other study ID #: 5870E
• Secondary ID: R03CA259898
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to address barriers to psychosocial care for siblings of children with cancer by piloting a group-based telehealth program for adolescent siblings of youth with cancer. The pilot trial will be preceded by a treatment development stage during which study staff will interview English- and Spanish-speaking families and psychosocial providers to assess preferences for program content, format, timing, and cultural feasibility and acceptability, while considering ideas to minimize participation barriers. Information from interviews will inform any revisions to the proposed pilot program. Then, the new SibACCESS program will be tested with a small group of families located in Massachusetts, Delaware, or Rhode Island using video-teleconferencing technology. Families will complete exit interviews to assess program acceptability and perceived benefits.

Description:

Background:

Prolonged, complicated, and intensive pediatric cancer treatment regimens challenge and disrupt the entire family. Siblings of youth with cancer are a psychosocially at-risk and underserved group. Siblings frequently report strong negative emotions, disruptions to family life, poorer academic functioning, more school absenteeism (school-aged siblings), and riskier health behaviors and poorer health outcomes than comparisons (adult siblings). Approximately one-quarter of siblings meet diagnostic criteria for cancer-related posttraumatic stress disorders. Outcomes are worse for siblings from under-represented minority groups and those with fewer socioeconomic resources. Additionally, siblings report low social support and indicate a strong desire to connect with other siblings. The need for sibling support is well established, as outlined in the recently developed evidence- and consensus-based Standards for Psychosocial Care for Children with Cancer and Their Families. Unfortunately, the Sibling Standard is among those least likely to be met within pediatric oncology programs nationwide.

SibACCESS Program Description:

SibACCESS (Acceptance, Coping, Communication, Engagement, and Social Support) targets the proposed mechanisms of sibling difficulties. The primary goal is to increase siblings' exposure and opportunities to process cancer-related cues to decrease the onset or intensification of posttraumatic stress (PTS). Treatment targets include emotional acceptance, treatment involvement, family communication (via between-session assignments), and social support (fostered by the group format).

SibACCESS is based on acceptance-based cognitive-behavioral frameworks, drawing primarily on trauma-focused CBT (TF-CBT). TF-CBT is a structured, short-term treatment that incorporates cognitive-behavioral approaches to promote recovery from trauma. It is a logical starting point for the present study for multiple reasons: (a) TF-CBT was developed specifically for children and adolescents; parent participation is recommended but not required; (b) it has been tested in a group format and using telehealth; (c) it has demonstrated effectiveness across cultural groups; and (d) it is appropriate for youth who meet diagnostic criteria for PTSD and those with sub-clinical PTS. TF-CBT has not yet been evaluated in the context of childhood cancer and may require some adaptations. Thus, SibACCESS also includes skills from Dialectical and Behavioral Therapy (i.e., self-validation of emotions, mindfulness, radical acceptance) to better address distress tolerance and acceptance of the aspects of cancer that are beyond siblings' control.

SibACCESS sessions will be facilitated remotely using Zoom. The intervention includes one pre-recorded parent webinar, one brief orientation meeting (sibling and parent), seven weekly sibling group sessions, one individual sibling session, and one individual parent session. The 30-minute parent webinar will provide a program overview, psychoeducation, and brief skills training. Parents will be given "discussion starter" questions to facilitate communication throughout the program. Sibling group sessions are 75 minutes and will include an ice breaker, review of last week's homework (except first session), introduction of new topics, interactive practice of new skills, and assignment of home practice (except final session). Exposure to cancer-related emotions and cues will be emphasized throughout the program, including talking about cancer, confronting cancer-related thoughts and emotions, selecting several individualized cancer-related exposures, and crafting a sibling narrative.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 2 or more children in the family (i.e., child with cancer and >1 sibling)

• Sibling(s) and child with cancer each under the age of 18 at the time of cancer diagnosis

• Sibling(s) can be biologically-related, step-siblings, foster-siblings, or adopted-siblings

• Parent and sibling(s) fluent in English

• Sibling(s) 12-17 years of age

• Sibling report of at least mild posttraumatic stress (score >11 on the Child Posttraumatic Stress Scale for DSM-5)

• Child with cancer must have received cancer diagnosis at least 3 months prior to the family's enrollment in the study

Exclusion Criteria:

• A cognitive impairment that would interfere with pilot program and interview completion (as reported by parent)

• Bereavement

• Significant externalizing behaviors that would interfere with group participation (as reported by parent)

Related Conditions & MeSH terms

• Childhood Cancer
• Pediatric Cancer
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• SibACCESS
The primary goal of the SibACCESS program is to increase siblings' exposure to and opportunity to process cancer-related cues to decrease onset or intensification of posttraumatic stress. The program is focused on siblings, with a brief parent education component. Parents will receive psychoeducation and brief skills training to support siblings enrolled in the program. Siblings will participate in 7 group sessions and one individual session in which they will learn skills and strategies to confront information about cancer and tolerate uncomfortable thoughts and feelings related to cancer, and thereby reduce avoidance of cancer-related emotions.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University Charles River Campus	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Posttraumatic Stress Disorder Symptom Scale for DSM-5	Measure of youth posttraumatic stress symptoms (score range: 0-80; higher scores reflect more posttraumatic stress)	through study completion, an average of 4 months