NCT05808114

Brief Summary

This study examines the immediate and long-term effectiveness of a group cognitive behavioral therapy intervention (GCBT) in improving health-related quality of life (HRQOL) in children treated for mixed psychiatric disorders in naturalistic child psychiatric outpatient settings. The effects of a treatment-as-usual condition (TAU) is also examined. Further, the study aims to explore the associations among children´s HRQOL dimensions and parental well-being, and how GCBT may influence these associations.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable quality-of-life

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
Last Updated

April 11, 2023

Status Verified

March 1, 2023

Enrollment Period

3.5 years

First QC Date

March 15, 2023

Last Update Submit

March 29, 2023

Conditions

Quality of Life

Keywords

Quality of lifeHealth-related quality of lifeChildrencognitive behavioral therapygroup cognitive behavioral therapyparental wellbeing

Outcome Measures

Primary Outcomes (2)

  • Changes in self-and parent-rated health-related quality of life after the group cognitive behavior therapy (GCBT) intervention

    Children´s health-related quality of life measured using the KINDL-R measure, total scores range from 0-100 with higher scores indicating better health-related quality of life

    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

  • Changes in self-and parent-rated health-related quality of life after treatment as usual (TAU)

    Children´s health-related quality of life measured using the KINDL-R measure, total scores range from 0-100 with higher scores indicating better health-related quality of life

    Before and after TAU (duration circa 3.2 months)

Secondary Outcomes (3)

  • Associations among children´s health-related quality of life and parental well-being dimensions

    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

  • Associations among children´s HRQOL and parental well-being dimensions (parental psychological distress)

    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

  • Associations among children´s HRQOL and parental well-being dimensions (parental 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 (2)

Group cognitive behavioral therapy

EXPERIMENTAL

Friends Program

Behavioral: Friends program

Treatment as Usual

EXPERIMENTAL

A TAU condition during which participants received routine care services tailored to each child individually.

Behavioral: TAU

Interventions

Friends programBEHAVIORAL

A GCBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions

Group cognitive behavioral therapy
TAUBEHAVIORAL

Individually tailored and delivered specialized child psychiatric care

Treatment as Usual

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • child psychiatric outpatient care
  • sufficient skills to participate in group sessions

You may not qualify if:

  • child psychiatric inpatient care
  • acute suicidality
  • excessive physical aggression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2023

First Posted

April 11, 2023

Study Start

July 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 11, 2023

Record last verified: 2023-03