Cystic Fibrosis (CF)TIDES 2NCT07048574
TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
An observational study of Cystic Fibrosis (CF), run by State University of New York at Buffalo at 13 sites in United States.
Trial summary
This is a longitudinal, observational epidemiological study designed to estimate the prevalence of depression, anxiety, and behavior problems in children ages 18 months through 11 years with cystic fibrosis (CF). Read more about this study
- Who is it for?
- Ages 18 months to 11 years
- Conditions the study is for
- Cystic Fibrosis (CF)
- How many people
- 600 participants
- Where
- 13 sitesUnited States
- Study dates
- 2 Jun 2025to 30 Jun 2028
- 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 18 months to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with Cystic Fibrosis between 18 months and 11 years
Who may be able to join
- Child with a diagnosis of Cystic fibrosis (CF) actively followed by the CF care team at a participating site
- Child is age 18 months thru 11 years
- English and/or Spanish speaking
- Parent/legal guardian willing and able to give informed consent, and for minor participants ages 7 thru 11 years able to give assent.
Who cannot join
- Unable or unwilling to participate in study procedures, or at Site PI discretion.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Minu Mohan, MPH contact
13 sites in 1 country
United States13 sites, 12 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Emily Muther, PhD, 720- 777-3257, Emily.Muther@childrenscolorado.org
- Recruiting
Indiana University
Bloomington, Indiana, 47405
Emma M Tillman, PhD, PharmD, (317) 274-2797, emtillma@iu.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Anna M Georgiopoulos, MD, 617-724 -6300, AGEORGIOPOULOS@mgh.harvard.edu
- Recruiting
University at Buffalo
Buffalo, New York, 14215
Danielle M Goetz, MD, 716-323-0110, dgoetz@upa.chob.edu
- Recruiting
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
Mary Beth Prieur, PhD, 919-843-3209, mary_grimley@med.unc.edu
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Stephanie Filigno, PhD, 513-636-7793, stephanie.filigno@cchmc.org
- Recruiting
Joe DiMaggio
Hollywood, Florida, 33021
Alexandra L Quittner, PhD, 305-992-2411, aquittner@mhs.net
- Recruiting
Children's Hospital of Orange County
Orange, California, 92868
Adrianne Alpern, PhD, 657-767-2730, aalpern@choc.org
- Recruiting
Nemours Foundation
Orlando, Florida, 32827
David Fedele, PhD, 352-294-5765, David.Fedele@nemours.org
- Recruiting
UT Southwestern
Plano, Texas, 75235
Meghna Sathe, MD, 214-456-8000, meghna.sathe@utsouthwestern.edu
- Active, not recruiting
Brown University Health
Providence, Rhode Island, 02903
- Recruiting
Children's Hospital of Richmond at Virginia Commonwealth University
Richmond, Virginia, 23219
Michael S Schechter, MD, MPH, 410- 550-7755, michael.schechter@vcuhealth.org
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Freda Liu, PhD, 206-987-3295, freda.liu@seattlechildrens.org
About this study
This is a longitudinal, observational epidemiological study designed to estimate the prevalence of depression, anxiety, and behavior problems in children ages 18 months through 11 years with cystic fibrosis (CF).
Read the detailed description
Integration of mental health (MH) screening and treatment into cystic fibrosis (CF) care represents over 10 years of research and clinical progress, driven by elevated rates of depression and anxiety in the International Depression Epidemiological Study, MH guidelines, and CF Foundation implementation support to screen adolescents and adults in all CF Centers. Benefits of screening include earlier identification, greater access to care, reduced stigma, and positive uptake from the CF community.
However, TIDES did not include children with CF under 12 years. Depression and anxiety have increased dramatically in young children, with new guidelines for MH screening of children in primary care. Given the pediatric MH crisis and the widespread adoption of cystic fibrosis fibrosis transmembrane conductance regulator (CFTR) modulator therapy, which have been associated with adverse events, there is an urgent need to gather MH data in children with CF <12 years. Thus, the goals of this study are to evaluate the national, longitudinal prevalence of depression, anxiety, and behavior problems in children with CF 18 months through 11 years, evaluate and compare the performance of two widely used brief screeners (criterion validity, sensitivity, specificity) to identify the optimal measures for this population, and characterize neuropsychiatric adverse events (AEs) associated with CFTR modulator therapy in this age group. Purposive randomized sampling will be used to recruit 600 children (half 18 mos.-5 yrs. and half 6-11 yrs.) at 16 CF Centers across the US. This study will estimate the prevalence of children above the clinical cut-score on each symptom domain (depression, anxiety, behavior problems) and evaluate their longitudinal course and predictors. Rigorous mixed methods will be used to describe any potential AEs perceived by parents or children to be associated with CFTR modulator therapy. This study will provide the groundwork to extend mental health screening and care to younger children with CF.
- Conditions
- Cystic Fibrosis (CF)
- Keywords
- Cystic Fibrosis, Children, Mental health screening, Depression, Anxiety, CFTR modulators, Neuropsychiatric adverse events
- Medical subject headings
- Cystic Fibrosis, Depression, Anxiety Disorders
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 |
|---|---|---|
| Preschool / Early Childhood Group (18 mos - 5 years) | 300 children with CF and their parents will be recruited. This cohort will help identify early signs of internalizing and externalizing behaviors, attention-related concerns, and the impact of CF treatments on psychosocial health. Children in this cohort may also be identified for participation in Aim 3 if they are on or eligible for modulator therapy. | |
| School-Age Group (6 - 11 years) | 300 children with CF and their parents will be recruited. Includes school-aged children who can self-report their emotional and behavioral health, beginning at age 8 years. This group will be assessed for emerging mental health symptoms, cognitive development, and procedural anxiety related to CF treatments. Children in this cohort may also be identified for participation in Aim 3 if they are on or eligible for modulator therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of depression, anxiety, and behavioral problems in children with cystic fibrosis
Estimate the national prevalence of depression, anxiety, and behavioral problems among children with cystic fibrosis aged 18 months through 11 years using the Behavior Assessment System for Children, Third Edition (BASC-3). At the baseline assessment (Time 1), parents complete the age-appropriate BASC-3 Parent Rating Scale, and children aged 8-11 years complete the BASC-3 Self-Report of Personality. BASC-3 classifications of emotional and behavioral symptoms will be used to estimate the prevalence of clinically significant symptoms.
Measured: 07/01/2024 - 06/30/2028
Secondary outcomes (6)
Diagnostic performance of brief behavioral and mental health screening instruments
Evaluate the diagnostic accuracy and clinical utility of the Pediatric Symptom Checklist (PSC-Preschool, PSC-17, and PSC-Y-17) and PROMIS short forms for anxiety, depressive symptoms, anger/irritability, sleep disturbance, cognitive functioning, flexibility, and persistence by comparing their performance with BASC-3 at baseline.
Measured: 07/01/2024 - 06/30/2028
Longitudinal changes in child mental health symptoms
Assess changes in parent-reported and child self-reported mental health symptoms over three study assessments using PSC and PROMIS measures. BASC-3 is administered only at the first assessment.
Measured: 07/01/2024 - 06/30/2028
Cystic fibrosis-specific health-related quality of life
Assess CF-specific health-related quality of life using age-appropriate versions of the Cystic Fibrosis Questionnaire-Revised (CFQ-R). Parent-proxy and child self-report versions are administered according to participant age, with the Preschool Pictorial CFQ-R administered once for eligible children.
Measured: 07/01/2024 - 06/30/2028
Parent symptoms of depression and anxiety
Assess parent mental health using the Patient Health Questionnaire-8 (PHQ-8) and Generalized Anxiety Disorder-7 (GAD-7) at each assessment.
Measured: 07/01/2024 - 06/30/2028
Neuropsychiatric symptoms associated with CFTR modulator therapy
Evaluate parent-reported new or worsening neuropsychiatric symptoms following initiation of elexacaftor/tezacaftor/ivacaftor (ETI) or vanzacaftor/tezacaftor/deutivacaftor (VTD) using the CFTR Modulator Survey. Symptoms include anxiety, depression, attention problems, behavioral dysregulation, irritability, and sleep disturbance. The Modified Naranjo Scale will be used to assess the likelihood that reported symptoms are related to CFTR modulator therapy.
Measured: 07/01/2024 - 06/30/2028
Qualitative experiences related to CFTR modulator-associated neuropsychiatric symptoms
Conduct semi-structured qualitative interviews with a purposive sample of parents reporting worsening neuropsychiatric symptoms following CFTR modulator initiation or non-initiation because of mental health concerns. Eligible school-aged children may also participate. Interview transcripts will undergo thematic analysis.
Measured: 07/01/2024 - 06/30/2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start2 Jun 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Brown University
- Responsible party
- Principal investigator, Beth A Smith, MD, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048574
- Sponsor's protocol ID
- STUDY00008868
- Other IDs
- SMITH 24A0
- Acronym
- TIDES 2
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An application process will be established for external data requests. Initially, data access will be granted upon request by Brown University Health (BUH), with full public access only after a defined period following study completion. Beyond academic publications, BUH will contribute to the creation of publicly available study summaries, ensuring that key findings are accessible to the CF community, healthcare providers, and patient advocacy groups.
Publications
Quittner AL, Goldbeck L, Abbott J, Duff A, Lambrecht P, Sole A, Tibosch MM, Bergsten Brucefors A, Yuksel H, Catastini P, Blackwell L, Barker D. Prevalence of depression and anxiety in patients with cystic fibrosis and parent caregivers: results of The International Depression Epidemiological Study across nine countries. Thorax. 2014 Dec;69(12):1090-7. doi: 10.1136/thoraxjnl-2014-205983. Epub 2014 Sep 21.
PubMed 25246663Smith BA, Barker DH, Georgiopoulos AM, Schechter MS, Mohan MP, Singh L, Mutti G, Quittner AL. TIDES 2.0: A protocol for examining the prevalence and longitudinal course of depression, anxiety and behaviour problems in children with cystic fibrosis under 12 years of age. BMJ Open Respir Res. 2026 Sep 22;13(1):e004611. doi: 10.1136/bmjresp-2026-004611.
PubMed 42772816
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
- ClinicalTrials.gov ID
- NCT07048574
- Acronym / sponsor ID
- TIDES 2 / STUDY00008868
- Conditions
- Cystic Fibrosis (CF)
- Keywords
- Cystic Fibrosis, Children, Mental health screening, Depression, Anxiety, CFTR modulators, Neuropsychiatric adverse events
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Brown University
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 Jul 2025 (actual)
- 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 is a longitudinal, observational epidemiological study designed to estimate the prevalence of depression, anxiety, and behavior problems in children ages 18 months through 11 years with cystic fibrosis (CF).
Detailed description
Integration of mental health (MH) screening and treatment into cystic fibrosis (CF) care represents over 10 years of research and clinical progress, driven by elevated rates of depression and anxiety in the International Depression Epidemiological Study, MH guidelines, and CF Foundation implementation support to screen adolescents and adults in all CF Centers. Benefits of screening include earlier identification, greater access to care, reduced stigma, and positive uptake from the CF community.
However, TIDES did not include children with CF under 12 years. Depression and anxiety have increased dramatically in young children, with new guidelines for MH screening of children in primary care. Given the pediatric MH crisis and the widespread adoption of cystic fibrosis fibrosis transmembrane conductance regulator (CFTR) modulator therapy, which have been associated with adverse events, there is an urgent need to gather MH data in children with CF <12 years. Thus, the goals of this study are to evaluate the national, longitudinal prevalence of depression, anxiety, and behavior problems in children with CF 18 months through 11 years, evaluate and compare the performance of two widely used brief screeners (criterion validity, sensitivity, specificity) to identify the optimal measures for this population, and characterize neuropsychiatric adverse events (AEs) associated with CFTR modulator therapy in this age group. Purposive randomized sampling will be used to recruit 600 children (half 18 mos.-5 yrs. and half 6-11 yrs.) at 16 CF Centers across the US. This study will estimate the prevalence of children above the clinical cut-score on each symptom domain (depression, anxiety, behavior problems) and evaluate their longitudinal course and predictors. Rigorous mixed methods will be used to describe any potential AEs perceived by parents or children to be associated with CFTR modulator therapy. This study will provide the groundwork to extend mental health screening and care to younger children with CF.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preschool / Early Childhood Group (18 mos - 5 years) | – | –300 children with CF and their parents will be recruited. This cohort will help identify early signs of internalizing and externalizing behaviors, attention-related concerns, and the impact of CF treatments on psychosocial health. Children in this cohort may also be identified for participation in Aim 3 if they are on or eligible for modulator therapy. |
| School-Age Group (6 - 11 years) | – | –300 children with CF and their parents will be recruited. Includes school-aged children who can self-report their emotional and behavioral health, beginning at age 8 years. This group will be assessed for emerging mental health symptoms, cognitive development, and procedural anxiety related to CF treatments. Children in this cohort may also be identified for participation in Aim 3 if they are on or eligible for modulator therapy. |
Who may qualify
- Ages
- 18 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with Cystic Fibrosis between 18 months and 11 years
Key inclusion criteria (4 listed)
- Child with a diagnosis of Cystic fibrosis (CF) actively followed by the CF care team at a participating site
- Child is age 18 months thru 11 years
- English and/or Spanish speaking
- Parent/legal guardian willing and able to give informed consent, and for minor participants ages 7 thru 11 years able to give assent.
Key exclusion criteria (1 listed)
- Unable or unwilling to participate in study procedures, or at Site PI discretion.
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
Prevalence of depression, anxiety, and behavioral problems in children with cystic fibrosis
Time frame: 07/01/2024 - 06/30/2028
Estimate the national prevalence of depression, anxiety, and behavioral problems among children with cystic fibrosis aged 18 months through 11 years using the Behavior Assessment System for Children, Third Edition (BASC-3). At the baseline assessment (Time 1), parents complete the age-appropriate BASC-3 Parent Rating Scale, and children aged 8-11 years complete the BASC-3 Self-Report of Personality. BASC-3 classifications of emotional and behavioral symptoms will be used to estimate the prevalence of clinically significant symptoms.
6 secondary outcomes
Diagnostic performance of brief behavioral and mental health screening instruments
Time frame: 07/01/2024 - 06/30/2028
Longitudinal changes in child mental health symptoms
Time frame: 07/01/2024 - 06/30/2028
Cystic fibrosis-specific health-related quality of life
Time frame: 07/01/2024 - 06/30/2028
Parent symptoms of depression and anxiety
Time frame: 07/01/2024 - 06/30/2028
Neuropsychiatric symptoms associated with CFTR modulator therapy
Time frame: 07/01/2024 - 06/30/2028
Qualitative experiences related to CFTR modulator-associated neuropsychiatric symptoms
Time frame: 07/01/2024 - 06/30/2028
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 3 Nov 2026.
- Background: PubMed 25246663Quittner AL, Goldbeck L, Abbott J, Duff A, Lambrecht P, Sole A, Tibosch MM, Bergsten Brucefors A, Yuksel H, Catastini P, Blackwell L, Barker D. Prevalence of depression and anxiety in patients with cystic fibrosis and parent caregivers: results of The International Depression Epidemiological Study across nine countries. Thorax. 2014 Dec;69(12):1090-7. doi: 10.1136/thoraxjnl-2014-205983. Epub 2014 Sep 21.
- Derived from this study: PubMed 42772816Smith BA, Barker DH, Georgiopoulos AM, Schechter MS, Mohan MP, Singh L, Mutti G, Quittner AL. TIDES 2.0: A protocol for examining the prevalence and longitudinal course of depression, anxiety and behaviour problems in children with cystic fibrosis under 12 years of age. BMJ Open Respir Res. 2026 Sep 22;13(1):e004611. doi: 10.1136/bmjresp-2026-004611.
- Individual participant dataSharing planned: Yes. An application process will be established for external data requests. Initially, data access will be granted upon request by Brown University Health (BUH), with full public access only after a defined period following study completion. Beyond academic publications, BUH will contribute to the creation of publicly available study summaries, ensuring that key findings are accessible to the CF community, healthcare providers, and patient advocacy groups.
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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.
Minu Mohan, MPH contact
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis (CF), run by State University of New York at Buffalo at 13 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
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?
Contact Beth A Smith, MD (716-898-5940, balucas@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of depression, anxiety, and behavioral problems in children with cystic fibrosis (time frame: 07/01/2024 - 06/30/2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07048574, which also lists 2 linked publications.
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 3 Nov 2026.