Hair Cortisol and Symptoms in Children With Psychopathology During CBT

NCT06274424 | Completed

• 1 other identifier: HUS/211/2016 and HUS/2699/2018
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Child Behavior Problem

Keywords

Children; group cognitive behavioral therapy; hair cortisol concentration; internalizing symptoms; externalizing symptoms; sleep disturbance symptoms

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Group Cognitive Behavioral Therapy Intervention

EXPERIMENTAL

The Friends Program

Behavioral: The Friends Program

Interventions

The Friends Program BEHAVIORAL

A group CBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions.

Group Cognitive Behavioral Therapy Intervention

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 23, 2024
• Study Start: July 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share