Childhood CancersP-SCIPNCT00939380
Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial
A study testing Behavioral intervention sessions, CD-ROM and DVD and pamphlet in people with Childhood Cancers, run by Rutgers, The State University of New Jersey at 5 sites in United States.
Trial summary
The investigators have developed a parent social-cognitive processing intervention (P-SCIP) to help decrease distress among parent caregivers of children undergoing hematopoietic stem cell transplant (HSCT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Cancers
- What is being tested?
- Behavioral intervention sessions, CD-ROM and DVD and pamphlet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2010to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- biological or foster parent of children under 19 years of age who are scheduled for HSCT within the next month
- participant is the primary caregiver
- participant must have phone service
- caregiver speaks, reads, and writes English or Spanish (Spanish is for Childrens Hospital Los Angeles and Columbia University only)
Who cannot join
- pediatric patient has a diagnosis of medulloblastoma or other cancer of the brain
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University/Childrens Healthcare of Atlanta
Atlanta, Georgia, 30322
Childrens Hospital Los Angeles
Los Angeles, California, 90027
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 080903
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Columbia University
New York, New York, 10032
About this study
The investigators have developed a parent social-cognitive processing intervention (P-SCIP) to help decrease distress among parent caregivers of children undergoing hematopoietic stem cell transplant (HSCT). The investigators will evaluate the efficacy of P-SCIP in reducing short- and long-term distress and parenting stress among 300 parents of children undergoing HSCT. P-SCIP will be delivered during the child's inpatient HSCT hospitalization and is specifically designed to improve parent social (e.g., sharing concerns) and cognitive (e.g., acceptance) processing of the transplant experience. The intervention includes five in-person sessions that are accompanied by an interactive CD-ROM. The CD-ROM complements the materials in the in-person sessions and provides parents with the opportunity to enhance and deepen their cognitive and social processing of the HSCT experience. The intervention will be tested against best-practices psychosocial care (BPC) available in four enriched pediatric HSCT settings across the United States. P-SCIP will be provided to both Spanish- and English-speaking parents. Participants will complete measures of psychological distress, well-being, and social and cognitive processing at the time of HSCT, two, six and twelve months after HSCT. Research questions will address the effects of P-SCIP versus BPC on parent psychological adaptation and social and cognitive processing, as well as evaluate parent personal resources as well as child medical course variables that contribute to intervention response. The investigators will also examine barriers to participation in the intervention by comparing barriers to participation among parents who refuse participation in the trial and parents who accept.
- Conditions
- Childhood Cancers
- Being tested
- Behavioral intervention sessions, CD-ROM, DVD and pamphlet, Respite care
- Keywords
- hematopoietic stem cell transplant, bone marrow transplant, children, parents, counseling, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral intervention sessionsBehavioural
Participants undergo five 60-minute behavioral intervention sessions once or twice weekly for 3 weeks to learn how to engage in effective social and cognitive processing to deal with fears and worries about the transplant and transplant-related concerns.
CD-ROMOther
Participants receive a laptop computer and a CD-ROM after the first session of behavioral intervention.
DVD and pamphletOther
Participants receive a "Discovery to Recovery" DVD and pamphlet developed by the National Marrow Donor Program (NMDP) describing psychological issues associated with hematopoietic stem cell transplantation (HSCT), the booklet "Top Tips for Parent Caregivers During the BMT Process" published by National Marrow Donor Program-Link describing caregiver issues during HSCT and advice on how to handle them, 2 walkie-talkies, a laptop to view the DVD.
Respite careOther
Participants receive 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| P-SCIP | Experimental | Arm I (Parent Social-Cognitive Intervention Program [P-SCIP]): Participants undergo five 60-minute behavioral intervention sessions once or twice weekly for 3 weeks to learn how to engage in effective social and cognitive processing to deal with fears and worries about the transplant and transplant-related concerns. Participants receive a laptop computer and a CD-ROM after the first session. Receives: Behavioral: Behavioral intervention sessions; Other: CD-ROM |
| BPC | Experimental | Arm II (Best-recommended Psychosocial Care [BPC]): Participants undergo usual care and receive a "Discovery to Recovery" DVD and pamphlet developed by the National Marrow Donor Program (NMDP) describing psychological issues associated with hematopoietic stem cell transplantation (HSCT), the booklet "Top Tips for Parent Caregivers During the BMT Process" published by National Marrow Donor Program-Link describing caregiver issues during HSCT and advice on how to handle them, 2 walkie-talkies, a laptop to view the DVD, and 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks. Receives: Other: DVD and pamphlet; Other: Respite care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
Measured: 7 years
Beck Anxiety Inventory
Measured: 7 years
Mental Health Inventory
Measured: 7 years
Impact of Events Scale-Revised
Measured: 7 years
Axis I Structured Clinical Interview for DSM-IV (SCID)
Measured: 7 years
Secondary outcomes (2)
Fear Structure
Measured: 7 years
Brief COPE
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startMay 2010
- Primary completionJan 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancersStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Children's Hospital Los Angeles, Columbia University, Emory University, Memorial Sloan Kettering Cancer Center, University of Medicine and Dentistry of New Jersey, Icahn School of Medicine at Mount Sinai, Weill Medical College of Cornell University, National Marrow Donor Program
- Responsible party
- Sponsor
- Investigators
- Sharon L Manne, Ph.D., Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939380
- Sponsor's protocol ID
- 130906
- Other IDs
- 1R01CA127488-01A1, CDR0000632012, FCCC-07848, 0220090280, P30CA072720, IRB#07-848; 15032-01
- Acronym
- P-SCIP
- Status last verified
- Mar 2016
- First submitted
- 14 Jul 2009
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial
- ClinicalTrials.gov ID
- NCT00939380
- Acronym / sponsor ID
- P-SCIP / 130906
- Conditions
- Childhood Cancers
- Keywords
- hematopoietic stem cell transplant, bone marrow transplant, children, parents, counseling, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Children's Hospital Los Angeles, Columbia University, Emory University, Memorial Sloan Kettering Cancer Center, University of Medicine and Dentistry of New Jersey, Icahn School of Medicine at Mount Sinai, Weill Medical College of Cornell University, National Marrow Donor Program
- Study start
- May 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have developed a parent social-cognitive processing intervention (P-SCIP) to help decrease distress among parent caregivers of children undergoing hematopoietic stem cell transplant (HSCT). The investigators will evaluate the efficacy of P-SCIP in reducing short- and long-term distress and parenting stress among 300 parents of children undergoing HSCT. P-SCIP will be delivered during the child's inpatient HSCT hospitalization and is specifically designed to improve parent social (e.g., sharing concerns) and cognitive (e.g., acceptance) processing of the transplant experience. The intervention includes five in-person sessions that are accompanied by an interactive CD-ROM. The CD-ROM complements the materials in the in-person sessions and provides parents with the opportunity to enhance and deepen their cognitive and social processing of the HSCT experience. The intervention will be tested against best-practices psychosocial care (BPC) available in four enriched pediatric HSCT settings across the United States. P-SCIP will be provided to both Spanish- and English-speaking parents. Participants will complete measures of psychological distress, well-being, and social and cognitive processing at the time of HSCT, two, six and twelve months after HSCT. Research questions will address the effects of P-SCIP versus BPC on parent psychological adaptation and social and cognitive processing, as well as evaluate parent personal resources as well as child medical course variables that contribute to intervention response. The investigators will also examine barriers to participation in the intervention by comparing barriers to participation among parents who refuse participation in the trial and parents who accept.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P-SCIP | Experimental | Behavioral: Behavioral intervention sessions, Other: CD-ROMArm I (Parent Social-Cognitive Intervention Program [P-SCIP]): Participants undergo five 60-minute behavioral intervention sessions once or twice weekly for 3 weeks to learn how to engage in effective social and cognitive processing to deal with fears and worries about the transplant and transplant-related concerns. Participants receive a laptop computer and a CD-ROM after the first session. |
| BPC | Experimental | Other: DVD and pamphlet, Other: Respite careArm II (Best-recommended Psychosocial Care [BPC]): Participants undergo usual care and receive a "Discovery to Recovery" DVD and pamphlet developed by the National Marrow Donor Program (NMDP) describing psychological issues associated with hematopoietic stem cell transplantation (HSCT), the booklet "Top Tips for Parent Caregivers During the BMT Process" published by National Marrow Donor Program-Link describing caregiver issues during HSCT and advice on how to handle them, 2 walkie-talkies, a laptop to view the DVD, and 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- biological or foster parent of children under 19 years of age who are scheduled for HSCT within the next month
- participant is the primary caregiver
- participant must have phone service
- caregiver speaks, reads, and writes English or Spanish (Spanish is for Childrens Hospital Los Angeles and Columbia University only)
Key exclusion criteria (1 listed)
- pediatric patient has a diagnosis of medulloblastoma or other cancer of the brain
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 |
|---|---|---|
| Behavioral intervention sessionsParticipants undergo five 60-minute behavioral intervention sessions once or twice weekly for 3 weeks to learn how to engage in effective social and cognitive processing to deal with fears and worries about the transplant and transplant-related concerns. | Behavioural | P-SCIP |
| CD-ROMParticipants receive a laptop computer and a CD-ROM after the first session of behavioral intervention. | Other | P-SCIP |
| DVD and pamphletParticipants receive a "Discovery to Recovery" DVD and pamphlet developed by the National Marrow Donor Program (NMDP) describing psychological issues associated with hematopoietic stem cell transplantation (HSCT), the booklet "Top Tips for Parent Caregivers During the BMT Process" published by National Marrow Donor Program-Link describing caregiver issues during HSCT and advice on how to handle them, 2 walkie-talkies, a laptop to view the DVD. | Other | BPC |
| Respite careParticipants receive 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks. | Other | BPC |
Primary outcome
Beck Depression Inventory
Time frame: 7 years
Beck Anxiety Inventory
Time frame: 7 years
Mental Health Inventory
Time frame: 7 years
Impact of Events Scale-Revised
Time frame: 7 years
Axis I Structured Clinical Interview for DSM-IV (SCID)
Time frame: 7 years
2 secondary outcomes
Fear Structure
Time frame: 7 years
Brief COPE
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
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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.
Sharon L Manne, Ph.D. principal investigator
Rutgers Cancer Institute of New Jersey
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral intervention sessions, CD-ROM and DVD and pamphlet in people with Childhood Cancers, run by Rutgers, The State University of New Jersey at 5 sites 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 4 inclusion and 1 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 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Beck Depression Inventory (time frame: 7 years). The study lists 5 primary outcomes in all. 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 10 Mar 2016.