Posttraumatic GrowthNCT01044160
Stress, Adjustment And Growth In Children With Cancer And Their Parents
An observational study of Posttraumatic Growth and Posttraumatic Stress Disorder, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This proposal examines trauma and growth responses in the childhood cancer experience. It addresses a number of gaps and unanswered questions in the literature, while integrating several distinct but related lines of research. The rationale for this proposal is outlined briefly as follows: 1. Read more about this study
- Who is it for?
- Ages 3 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Growth, Posttraumatic Stress Disorder
- How many people
- 663 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2009to 30 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Recruitment from the oncology group will be from outpatient clinics with procedures designed to obtain a representative sample of research participants, in terms of diagnosis and time since diagnosis. Control group participants will be accessed through schools in the greater Memphis area.
Who may be able to join
- Primary Group
- Research participant is 8-17 years inclusive
- Research participant has a primary diagnosis of malignancy
- Research participant is at least one month from diagnosis with no upper limit in terms of time elapsed since diagnosis;
- Research participant is able to speak and read English;
- Research participant does not have any significant cognitive or sensory deficits that would preclude participation;
Show all 27Show fewer
- Parent/LAR and research participant is willing to participate and provide consent/assent
- Young Child Group
- Research participant is 3 - 6 years of age, inclusive
- Primary diagnosis of malignancy
- At least one month from diagnosis
- One parent/LAR willing to participate and provide consent
- No history of sensory or developmental disorder that would invalidate study assessment procedures.
- Young Adult Group
- Research participant is 18-25 years of age inclusive
- Primary diagnosis of malignancy
- At least one month from diagnosis with no upper limit in terms of time elapsed from diagnosis
- Able to read and speak English
- No cognitive or sensory deficits that would preclude participation
- Willing to participate and provide consent
- Control Groups
- Research participant in 3 age groups (3 - 6 years; 8-17 years; 18-25 years) to match patient groups
- No history of chronic or life-threatening illness
- No cognitive or sensory impairment that would preclude completion of study measures
- Able to speak and read English
- Parent/LAR and research participant are willing to participate and provide informed consent/assent
- Exclusions Criteria:NA
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
This proposal examines trauma and growth responses in the childhood cancer experience. It addresses a number of gaps and unanswered questions in the literature, while integrating several distinct but related lines of research. The rationale for this proposal is outlined briefly as follows:
- Traumatic stress models focused on pathology dominate pediatric psychosocial oncology research despite empiric evidence of low levels of post-traumatic stress in this population.
- The assumption of 'cancer as a traumatic event' has biased research designs (including lack of control comparisons) to focus on deficits and pathological outcomes.
- This deficit-oriented approach has stimulated the development of interventions to treat or prevent PTSD, which may be unnecessary or even harmful.
- Theoretical and empiric evidence suggests that a more common response to traumatic stress is growth and positive change, but posttraumatic growth phenomenon have been understudied in pediatric populations.
- Cognitive and personality factors are important determinants of PTSD and positive growth outcomes, and some constructs from positive psychology theory may be particularly relevant in children with cancer.
- Empirically, parents of children with cancer appear to be at higher risk of PTSD/PTSS, although results are not unequivocal, and the same research biases have applied to parental outcomes. This proposal includes assessment of parental PTSS and PTG, both as an outcome and a predictor of child outcomes.
Read the detailed description
This study examines the following outcomes:
- To examine outcomes of posttraumatic growth and benefit finding (PTG) in children with cancer/cancer survivors in comparison to a population of children without history of serious illness.
- To examine outcomes of posttraumatic stress (PTSS/PTSD) in children with cancer/cancer survivors in comparison to children without a history of serious illness.
- To examine predictors of child posttraumatic stress and posttraumatic growth from medical variables, life events history, family environment, and child personality variables.
- To apply an accelerated longitudinal design to examine trajectories of both pathological outcomes such as posttraumatic stress (PTSS) and positive outcomes such as challenge-related growth (CRG) in children with cancer/cancer survivors in comparison to a population of children without a history of serious illness. Additional observations will be obtained at 1-, 3-, and 5-years post study entry.
- To examine outcomes of PTG and PTSS/PTSD in parents of children with cancer/cancer survivors in comparison to parents of healthy children. Parental PTSS/PTSD and PTG will be examined both as outcomes and as predictors of child outcomes.
- To examine predictors of parent PTSS/PTSD and PTG from demographic and medical variables, life events history, and parent personality variables.
- To determine the sensitivity/specificity of measures of PTSS in screening for PTSD based on diagnostic interview.
- To examine the validity and reliability of a new measure of child personality, the Child and Adolescent Five Factor Inventory (CAFFI).
- To examine emerging social developmental outcomes in this longitudinal cohort.
- To develop an electronic version of the study measures and to compare data obtained electronically (on desktop or laptop computer), with data obtained on paper for comparability in reliability and outcomes obtained.
- Keywords
- cancer as trauma in children, PTG/PTSS/ PTSD in children with cancer vs healthy children
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oncology Group | The study will recruit from outpatient clinics with procedures designed to obtain a representative sample of research participants, in terms of diagnosis and time since diagnosis. | |
| Control Group | The study will first identify a large cohort of children who are willing to participate, and then call them back individually as they are found to match participants in the cancer group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine outcomes of posttraumatic growth and benefit finding (PTG) in children with cancer/cancer survivors in comparison to a population of children without history of serious illness.
Measured: 5 years post study entry
Examine outcomes of posttraumatic stress (PTSS/PTSD) in children with cancer/cancer survivors in comparison to children without a history of serious illness.
Measured: 5 years post study entry
Examine predictors of child posttraumatic stress and posttraumatic growth from medical variables, life events history, family environment, and child personality variables.
Measured: 5 years post study entry
Examine difference in trajectories of pathological outcomes and positive outcomes between children with cancer/cancer survivors and children without a history of serious illness.
Measured: 5 years post study entry
Secondary outcomes (6)
Examine outcomes of PTG and PTSS/PTSD in parents of children with cancer/cancer survivors in comparison to parents of healthy children. Parental PTSS/PTSD and PTG will be examined both as outcomes and as predictors of child outcomes.
Measured: 5 years post study entry
Examine predictors of parent PTSS/PTSD and PTG from demographic and medical variables, life events history, and parent personality variables.
Measured: 5 years post study entry
Determine the sensitivity/specificity of measures of PTSS in screening for PTSD based on diagnostic interview.
Measured: 5 years post study entry
Examine the validity and reliability of a new measure of child personality, the Child and Adolescent Five Factor Inventory (CAFFI).
Measured: 5 years post study entry
Describe emerging social developmental outcomes in the longitudinal cohort.
Use the Hemingway measure of social connectedness, and the Behavioral Assessment Scale for Children, 2nd Edition (BASC-2) by child, parent and teacher report.
Measured: 5 years post study entry
Compare data obtained electronically versus data obtained on paper for reliability and outcomes obtained.
Measured: 5 years post study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study start7 Jul 2009
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic GrowthStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 663 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sean Phipps, Ph.D, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044160
- Sponsor's protocol ID
- PTSD2
- Other IDs
- R01CA136782
- Status last verified
- Aug 2026
- First submitted
- 5 Jan 2010
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress, Adjustment And Growth In Children With Cancer And Their Parents
- ClinicalTrials.gov ID
- NCT01044160
- Acronym / sponsor ID
- PTSD2
- Keywords
- cancer as trauma in children, PTG/PTSS/ PTSD in children with cancer vs healthy children
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 663 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jul 2009 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 7 Jan 2010 (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.
This proposal examines trauma and growth responses in the childhood cancer experience. It addresses a number of gaps and unanswered questions in the literature, while integrating several distinct but related lines of research. The rationale for this proposal is outlined briefly as follows:
- Traumatic stress models focused on pathology dominate pediatric psychosocial oncology research despite empiric evidence of low levels of post-traumatic stress in this population.
- The assumption of 'cancer as a traumatic event' has biased research designs (including lack of control comparisons) to focus on deficits and pathological outcomes.
- This deficit-oriented approach has stimulated the development of interventions to treat or prevent PTSD, which may be unnecessary or even harmful.
- Theoretical and empiric evidence suggests that a more common response to traumatic stress is growth and positive change, but posttraumatic growth phenomenon have been understudied in pediatric populations.
- Cognitive and personality factors are important determinants of PTSD and positive growth outcomes, and some constructs from positive psychology theory may be particularly relevant in children with cancer.
- Empirically, parents of children with cancer appear to be at higher risk of PTSD/PTSS, although results are not unequivocal, and the same research biases have applied to parental outcomes. This proposal includes assessment of parental PTSS and PTG, both as an outcome and a predictor of child outcomes.
Detailed description
This study examines the following outcomes:
- To examine outcomes of posttraumatic growth and benefit finding (PTG) in children with cancer/cancer survivors in comparison to a population of children without history of serious illness.
- To examine outcomes of posttraumatic stress (PTSS/PTSD) in children with cancer/cancer survivors in comparison to children without a history of serious illness.
- To examine predictors of child posttraumatic stress and posttraumatic growth from medical variables, life events history, family environment, and child personality variables.
- To apply an accelerated longitudinal design to examine trajectories of both pathological outcomes such as posttraumatic stress (PTSS) and positive outcomes such as challenge-related growth (CRG) in children with cancer/cancer survivors in comparison to a population of children without a history of serious illness. Additional observations will be obtained at 1-, 3-, and 5-years post study entry.
- To examine outcomes of PTG and PTSS/PTSD in parents of children with cancer/cancer survivors in comparison to parents of healthy children. Parental PTSS/PTSD and PTG will be examined both as outcomes and as predictors of child outcomes.
- To examine predictors of parent PTSS/PTSD and PTG from demographic and medical variables, life events history, and parent personality variables.
- To determine the sensitivity/specificity of measures of PTSS in screening for PTSD based on diagnostic interview.
- To examine the validity and reliability of a new measure of child personality, the Child and Adolescent Five Factor Inventory (CAFFI).
- To examine emerging social developmental outcomes in this longitudinal cohort.
- To develop an electronic version of the study measures and to compare data obtained electronically (on desktop or laptop computer), with data obtained on paper for comparability in reliability and outcomes obtained.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oncology Group | – | –The study will recruit from outpatient clinics with procedures designed to obtain a representative sample of research participants, in terms of diagnosis and time since diagnosis. |
| Control Group | – | –The study will first identify a large cohort of children who are willing to participate, and then call them back individually as they are found to match participants in the cancer group. |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Recruitment from the oncology group will be from outpatient clinics with procedures designed to obtain a representative sample of research participants, in terms of diagnosis and time since diagnosis. Control group participants will be accessed through schools in the greater Memphis area.
Key inclusion criteria (27 listed)
- Primary Group
- Research participant is 8-17 years inclusive
- Research participant has a primary diagnosis of malignancy
- Research participant is at least one month from diagnosis with no upper limit in terms of time elapsed since diagnosis;
- Research participant is able to speak and read English;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Examine outcomes of posttraumatic growth and benefit finding (PTG) in children with cancer/cancer survivors in comparison to a population of children without history of serious illness.
Time frame: 5 years post study entry
Examine outcomes of posttraumatic stress (PTSS/PTSD) in children with cancer/cancer survivors in comparison to children without a history of serious illness.
Time frame: 5 years post study entry
Examine predictors of child posttraumatic stress and posttraumatic growth from medical variables, life events history, family environment, and child personality variables.
Time frame: 5 years post study entry
Examine difference in trajectories of pathological outcomes and positive outcomes between children with cancer/cancer survivors and children without a history of serious illness.
Time frame: 5 years post study entry
6 secondary outcomes
Examine outcomes of PTG and PTSS/PTSD in parents of children with cancer/cancer survivors in comparison to parents of healthy children. Parental PTSS/PTSD and PTG will be examined both as outcomes and as predictors of child outcomes.
Time frame: 5 years post study entry
Examine predictors of parent PTSS/PTSD and PTG from demographic and medical variables, life events history, and parent personality variables.
Time frame: 5 years post study entry
Determine the sensitivity/specificity of measures of PTSS in screening for PTSD based on diagnostic interview.
Time frame: 5 years post study entry
Examine the validity and reliability of a new measure of child personality, the Child and Adolescent Five Factor Inventory (CAFFI).
Time frame: 5 years post study entry
Describe emerging social developmental outcomes in the longitudinal cohort.
Time frame: 5 years post study entry
Compare data obtained electronically versus data obtained on paper for reliability and outcomes obtained.
Time frame: 5 years post study entry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Sean Phipps, Ph.D principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Growth and Posttraumatic Stress Disorder, run by St. Jude Children's Research Hospital 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 27 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Examine outcomes of posttraumatic growth and benefit finding (PTG) in children with cancer/cancer survivors in comparison to a population of children without history of serious illness. (time frame: 5 years post study entry). The study lists 4 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 24 Aug 2026.