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NCT04889755: R03 CA259898

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

Completed NA Results posted Last updated 17 February 2025
What this trial tests

NA trial testing SibACCESS in Siblings in 6 participants. Completed in 10 June 2023.

Timeline
1 February 2023
Primary endpoint
10 June 2023
10 June 2023

Quick facts

Lead sponsorBoston University Charles River Campus
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment6
Start date1 February 2023
Primary completion10 June 2023
Estimated completion10 June 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Boston University Charles River Campus

Who can join

12 and older, any sex, with Siblings or Childhood Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Child Posttraumatic Stress Disorder Symptom Scale for DSM-5 Primary · Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

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

GroupValue95% CI
SibACCESS (Sibling Participants)15.3± 3.5
Strengths & Difficulties Questionnaire (SDQ) Secondary · Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

The Strengths \& Difficulties Questionnaire (Goodman, 1997) is a 25-item measure of children's psychosocial adjustment. It has five scales: Emotional Symptoms, Conduct Symptoms, Hyperactivity/ Inattention Symptoms, Peer Relationship Problems, and Prosocial Behavior. Adapted versions were given to sibling (self-report) and parent (parent-report) participants. Measure was scored by a total summation reflecting total child difficulties, scores may range from 0-40. \*Higher scores reflect worse child difficulties

GroupValue95% CI
SibACCESS (Sibling Participants)16.3± 5.5
SibACCESS (Parent Participants)13.0± 2.8
Sibling Perception Questionnaire (SPQ) Secondary · Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

The Sibling Perception Questionnaire (SPQ) evaluates group interventions for siblings and parents designed to increase sibling understanding of and adjustment to chronic illness and developmental disability (CI/DD). Present measure was adapted from Sahler \& Carpenter (1989) and Lobato \& Kao (2002) versions to reflect cancer-related topics and create a parent-report version. Siblings and parents completed Sibling-report and Parent-report versions respectively. Measure was scored by a total summation, scores may range from 18 to 72. \*Higher scores reflect more negative sibling adjustment

GroupValue95% CI
SibACCESS (Sibling Participants)24.7± 13.9
SibACCESS (Parent Participants)36.5± 6.4
Coping Self-efficacy Scale Secondary · Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

The Coping self-efficacy scale (Chesney et. al, 2006) was used to assess participants' confidence in performing coping behaviors when faced with life challenges. This measure was only used with sibling participants. Measure was scored by a total summation, scores may range from 0 to 260. \*Higher scores reflect higher levels of coping self-efficacy

GroupValue95% CI
SibACCESS (Sibling Participants)188.0± 46.0
Emotional Avoidance Strategy Inventory For Adolescents Secondary · Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

The Emotional Avoidance Strategy Inventory for Adolescents (Kennedy \& Ehrenreich-May, 2017) is a 17-item measure of emotional avoidance with acceptable psychometrics. Measure was scored by a total summation, scores may range from 0-68.

GroupValue95% CI
SibACCESS (Sibling Participants)11.7± 12.0
Perceived Filial Self-Efficacy Scale Secondary · Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

The Perceived Filial Self-Efficacy Scale (PFSES) (Caprara et. al, 2004) is a 16-item measure that assess efficacy beliefs that family members hold about their role as spouse, parent, and child, as well as about the functioning of family as a holistic system. This survey was administered only to sibling participants. Measure was scored by a total summation, scores may range from 16 to 112. \*Higher scores reflect better efficacy beliefs

GroupValue95% CI
SibACCESS (Sibling Participants)89.7± 16.0
Sibling Cancer Needs Inventory (SCNI) Secondary · Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

The Sibling Cancer Needs Inventory (SCNI) (Patterson et. al, 2014) is a 45 item measure that assesses psychosocial needs of siblings are established to assist in the provision of appropriate support. This survey was administered only to sibling participants. The overall SCNI score are determined by summing the responses to all items, giving a possible range of SCNI scores from 45 to 180. \*Higher scores reflect higher sibling psychosocial needs

GroupValue95% CI
SibACCESS (Sibling Participants)68.7± 15.5
Acceptability of Program Secondary · Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks

Based from the Client Satisfaction Questionnaire (Roberts et. el, 1984), this measure assesses participants general acceptability of the SibACCESS intervention. Measure was scored by a total summation, scores may range from 0 to 52. \*Higher scores reflect higher levels of acceptability

GroupValue95% CI
SibACCESS (Sibling Participants)40.0± 7.0
SibACCESS (Parent Participants)40.0± 11.3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Siblings

Currently open trials in the same condition.

Other Boston University Charles River Campus trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04889755.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing