Hair Cortisol and Symptoms in Children With Psychopathology During CBT

Child Behavior Problem Clinical Trial

Official title:

Association Between Hair Cortisol and Symptoms in Children With Psychopathology During CBT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06274424
• Other study ID #: HUS/211/2016 and HUS/2699/2018
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: October 1, 2019

Study information

• Verified date: February 2024
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

Inclusion Criteria:

• symptoms of anxiety or depression
• deficiencies in emotional and behavioral skills impairing functioning
• sufficient social and cognitive skills to participate in group work.

Exclusion Criteria:

• excessive physical aggression
• excessive physical restlessness
• severity of psychiatric symptoms requiring individual psychotherapy (e.g., acute suicidality).

Related Conditions & MeSH terms

• Child Behavior Problem
• Problem Behavior

Intervention

Behavioral:
• The Friends Program
A group CBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair Cortisol Concentration	Level of hair cortisol concentration measured from hair samples	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
Primary	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	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
Primary	Child-rated internalizing symptoms	The Spence Children´s Anxiety Scale. A total score of 60 or higher is indicative of elevated anxiety.	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
Primary	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.	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