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Completed

NCT Number: NCT06274424

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.

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Key information

Conditions

Child Behavior Problem

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

The Friends program

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2024
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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