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

NCT04889755 | Completed Results

• 2 other identifiers: 5870ER03CA259898
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Siblings; Childhood Cancer; Pediatric Cancer; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Child Posttraumatic Stress Disorder Symptom Scale for DSM-5

  The Child PTSD Symptom Scale for DSM-5 (CPSS-V) \[citation\] is a 27-item measure of posttraumatic stress. Strong test-retest reliability, internal consistency, and convergent validity with other child PTSD measures have been established. This survey was administered only to sibling participants. Measure was scored by a total summation, scores may range from 0 to 80. \*Higher scores reflect higher levels of post-traumatic stress symptoms

  Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

Secondary Outcomes (7)

• Strengths & Difficulties Questionnaire (SDQ)

  Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

• Sibling Perception Questionnaire (SPQ)

  Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

• Coping Self-efficacy Scale

  Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

• Emotional Avoidance Strategy Inventory For Adolescents

  Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

• Perceived Filial Self-Efficacy Scale

  Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

Study Arms (1)

SibACCESS

OTHER

This is a single-arm trial of a group-based, posttraumatic stress intervention for adolescent siblings of children with cancer. The intervention includes a parent educational webinar, seven group sibling sessions, one individual parent session, and one individual sibling session.

Behavioral: SibACCESS

Interventions

SibACCESS BEHAVIORAL

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.

Also known as: SibACCESS (Acceptance, Coping, Communication, Engagement, and Social Support)

SibACCESS

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Neoplasms; Stress Disorders, Post-Traumatic

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The present study explores the greater development of a psychosocial intervention program for siblings of children with cancer. Above outcomes reflect data from a proof of concept trial (Phase 2) regarding the SibACCESS program, which was not designed to measure statistically significant results.

Results Point of Contact

• Title: Associate Professor
• Organization: Boston University

kalong@bu.edu

(617) 358-4296

Study Officials

• Kristin A. Long, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parent Pre-session: Webinar on Supporting Siblings Session 1 (Sibling Group): Program Introduction Session 2 (Sibling Group): Understanding Emotions Session 3 (Sibling Group): Adaptive Thinking Session 4 (Sibling Group): Sitting with Emotions Session 5 (Sibling Group): Avoidance vs. Sitting with Emotions Sessions 6 (Sibling Individual): Telling Your Story Session 7 (Sibling Group): Keeping up with Skills Session 8 (Parent Individual): Parent/caregiver Check-In Session 9 (Sibling Group): Wrap-Up

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: February 1, 2023
• Primary Completion: June 10, 2023
• Study Completion: June 10, 2023
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)