Active, not recruitingNCT01044160Updated Aug 24, 2026

Stress, Adjustment And Growth In Children With Cancer And Their Parents

An observational study in Posttraumatic Growth and Posttraumatic Stress Disorder, sponsored by St. Jude Children's Research Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 3 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by St. Jude Children's Research Hospital · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 663
Ages: 3 Years to 25 Years
Sex: All

Study 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:

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.

Conditions studied

Posttraumatic Growth
Posttraumatic Stress Disorder

Browse trials for

Stress Disorders, Post-Traumatic 2,239

Keywords

cancer as trauma in children
PTG/PTSS/ PTSD in children with cancer vs healthy children

In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's enrollment of 663 is above the median of 136 across 295 observational studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 3 Years to 25 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

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.

Eligibility criteria

Inclusion Criteria:

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;
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

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 663 participants (actual)

Groups and cohorts

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 researchers measure

Primary outcomes

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

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.
Use the Hemingway measure of social connectedness, and the Behavioral Assessment Scale for Children, 2nd Edition (BASC-2) by child, parent and teacher report.
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

Study locations

1 site

St. Jude Children's Research Hospital
Memphis, Tennessee 38105, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01044160
Lead sponsor: St. Jude Children's Research Hospital
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jan 7, 2010
Start date: Jul 7, 2009
Primary completion: Apr 30, 2029 (estimated)
Completion: Apr 30, 2029 (estimated)
Last update: Aug 24, 2026

Study contacts

Sean Phipps, Ph.D

principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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