Child Behavior ProblemNCT06274424
Hair Cortisol and Symptoms in Children With Psychopathology During CBT
A study testing The Friends Program in people with Child Behavior Problem, run by Helsinki University Central Hospital.
Trial summary
This study aims to examine the relationship between hair cortisol concentration and behavior and sleep disturbance symptoms in children with psychiatric disorders. It also investigates potential changes in hair cortisol and symptomatology after group-based cognitive behavior therapy. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Child Behavior Problem
- What is being tested?
- The Friends Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 1 Oct 2019
- 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 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- symptoms of anxiety or depression
- deficiencies in emotional and behavioral skills impairing functioning
- sufficient social and cognitive skills to participate in group work.
Who cannot join
- excessive physical aggression
- excessive physical restlessness
- severity of psychiatric symptoms requiring individual psychotherapy (e.g., acute suicidality).
About this study
Official title: Association Between Hair Cortisol and Symptoms in Children With Psychopathology During CBT
This study aims to examine the relationship between hair cortisol concentration and behavior and sleep disturbance symptoms in children with psychiatric disorders. It also investigates potential changes in hair cortisol and symptomatology after group-based cognitive behavior therapy. Furthermore, the study explores the effects of any alterations in hair cortisol concentration levels on potential behavior and sleep disturbance symptom change over the course of the study.
- Conditions
- Child Behavior Problem
- Being tested
- The Friends Program
- Keywords
- Children, group cognitive behavioral therapy, hair cortisol concentration, internalizing symptoms, externalizing symptoms, sleep disturbance symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Friends ProgramBehavioural
A group CBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group Cognitive Behavioral Therapy Intervention | Experimental | The Friends Program Receives: Behavioral: The Friends Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Cortisol Concentration
Level of hair cortisol concentration measured from hair samples
Measured: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
Parent- and teacher rated internalizing and externalizing symptoms
The Achenbach System of Empirically Based Assessment (ASEBA). Scores below 60 reflect the normal range, scores from 60 to 63 the borderline range, and scores above 63 the clinical range
Measured: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
Child-rated internalizing symptoms
The Spence Children´s Anxiety Scale. A total score of 60 or higher is indicative of elevated anxiety.
Measured: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
Parent-rated sleep disturbance symptoms
Sleep Disturbance Scale for Children (SDSC). A cutoff score of 39 and above has been suggested to identify children with sleep disturbance.
Measured: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Jul 2016
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior ProblemStudies of the same condition, open and under way.
- More trials run by Helsinki University Central 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarianna Barron-Linnankoski, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274424
- Sponsor's protocol ID
- HUS/211/2016 and HUS/2699/2018
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- 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 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Hair Cortisol and Symptoms in Children With Psychopathology During CBT
- ClinicalTrials.gov ID
- NCT06274424
- Acronym / sponsor ID
- HUS/211/2016 and HUS/2699/2018
- Conditions
- Child Behavior Problem
- Keywords
- Children, group cognitive behavioral therapy, hair cortisol concentration, internalizing symptoms, externalizing symptoms, sleep disturbance symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 23 Feb 2024 (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 study aims to examine the relationship between hair cortisol concentration and behavior and sleep disturbance symptoms in children with psychiatric disorders. It also investigates potential changes in hair cortisol and symptomatology after group-based cognitive behavior therapy. Furthermore, the study explores the effects of any alterations in hair cortisol concentration levels on potential behavior and sleep disturbance symptom change over the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Cognitive Behavioral Therapy Intervention | Experimental | Behavioral: The Friends ProgramThe Friends Program |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- symptoms of anxiety or depression
- deficiencies in emotional and behavioral skills impairing functioning
- sufficient social and cognitive skills to participate in group work.
Key exclusion criteria (3 listed)
- excessive physical aggression
- excessive physical restlessness
- severity of psychiatric symptoms requiring individual psychotherapy (e.g., acute suicidality).
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 |
|---|---|---|
| The Friends ProgramA group CBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions. | Behavioural | Group Cognitive Behavioral Therapy Intervention |
Primary outcome
Hair Cortisol Concentration
Time frame: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
Level of hair cortisol concentration measured from hair samples
Parent- and teacher rated internalizing and externalizing symptoms
Time frame: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
The Achenbach System of Empirically Based Assessment (ASEBA). Scores below 60 reflect the normal range, scores from 60 to 63 the borderline range, and scores above 63 the clinical range
Child-rated internalizing symptoms
Time frame: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
The Spence Children´s Anxiety Scale. A total score of 60 or higher is indicative of elevated anxiety.
Parent-rated sleep disturbance symptoms
Time frame: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
Sleep Disturbance Scale for Children (SDSC). A cutoff score of 39 and above has been suggested to identify children with sleep disturbance.
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 29 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The Friends Program in people with Child Behavior Problem, run by Helsinki University Central Hospital.
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 3 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 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Hair Cortisol Concentration (time frame: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up). 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 29 Feb 2024.