SiblingsR03 CA259898NCT04889755
SibACCESS: Developing a Telehealth Intervention to Address Unmet Psychosocial Needs of Siblings of Children With Cancer
A study testing SibACCESS in people with Siblings and Childhood Cancer, run by Boston University Charles River Campus at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Siblings, Childhood Cancer, Pediatric Cancer
- What is being tested?
- SibACCESS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 10 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Being tested
- SibACCESS
- Medical subject headings
- Neoplasms, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SibACCESSBehavioural
Also called SibACCESS (Acceptance, Coping, Communication, Engagement, and Social Support)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SibACCESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Secondary outcomes (7)
Strengths & Difficulties Questionnaire (SDQ)
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
Measured: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Sibling Perception Questionnaire (SPQ)
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
Measured: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Coping Self-efficacy Scale
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
Measured: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Emotional Avoidance Strategy Inventory For Adolescents
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.
Measured: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Perceived Filial Self-Efficacy Scale
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
Measured: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Sibling Cancer Needs Inventory (SCNI)
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
Measured: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Acceptability of Program
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
Measured: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Feb 2023
- Primary completion10 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SiblingsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kristin A. Long, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889755
- Sponsor's protocol ID
- 5870E
- Other IDs
- R03CA259898
- Acronym
- R03 CA259898
- Status last verified
- Jan 2025
- First submitted
- 11 May 2021
- Last updated
- 17 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SibACCESS: Developing a Telehealth Intervention to Address Unmet Psychosocial Needs of Siblings of Children With Cancer
- ClinicalTrials.gov ID
- NCT04889755
- Acronym / sponsor ID
- R03 CA259898 / 5870E
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Posted 17 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| SibACCESS | Other | Behavioral: SibACCESSThis 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 2 or more children in the family (i.e., child with cancer and >1 sibling)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SibACCESSAlso: SibACCESS (Acceptance, Coping, Communication, Engagement, and Social Support)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. | Behavioural | SibACCESS |
Primary outcome
Child Posttraumatic Stress Disorder Symptom Scale for DSM-5
Time frame: 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
7 secondary outcomes
Strengths & Difficulties Questionnaire (SDQ)
Time frame: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Sibling Perception Questionnaire (SPQ)
Time frame: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Coping Self-efficacy Scale
Time frame: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Emotional Avoidance Strategy Inventory For Adolescents
Time frame: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Perceived Filial Self-Efficacy Scale
Time frame: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Sibling Cancer Needs Inventory (SCNI)
Time frame: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Acceptability of Program
Time frame: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin A. Long, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SibACCESS in people with Siblings and Childhood Cancer, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Posttraumatic Stress Disorder Symptom Scale for DSM-5 (time frame: Within 2 weeks post-intervention, data were collected over a period of up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.