Mental Health ImpairmentPHUNCT04094324
Mental Health in Children and Youth Within Pediatric Care
An observational study of Mental Health Impairment and Obesity, Adolescent, run by Region Skane at 2 sites in Sweden.
Trial summary
Over the last decades, there has been an increase in the number of children and youth with mental illness, such as anxiety and depression. Mental illness in youth has a strong negative influence on the youth's quality of life and generally leads to dysfunction in several important areas, such as school and social… Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Mental Health Impairment, Obesity, Adolescent, IBD
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Oct 2020to 31 Dec 2025
- Phase
- Observational
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and youth (11-18y) who are patients at a pediatric clinic in Region Skåne SUS (obesity, gatronomy).
Who may be able to join
- Children and youth who are patients at a pediatric clinic in Region Skåne SUS(obesity, gatronomy)
Who cannot join
- Children who are unable to reply qustions on an iPad, due to language difficulties or cognitive challenges.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Mental Health in Children and Youth Within Pediatric Care.
Over the last decades, there has been an increase in the number of children and youth with mental illness, such as anxiety and depression. Mental illness in youth has a strong negative influence on the youth's quality of life and generally leads to dysfunction in several important areas, such as school and social activities. Early detection and treatment of mental illness entails great treatment benefits, and thus provide opportunity to prevent or reduce individual suffering.
Youth who suffer från Medical conditions, such as diabetes, epilepsy, gastro-intestinal disease, and obesity, show an increased risk of developing mental illness. There are well-established, careful programs for examining somatic co-morbidities to diseases in children and youth. Currently, despite the fact that mental illness is more common in these children than medical sequelae and despite that such a procedure is recommended, no routine exist for examining mental health in children and youth presenting for treatment at pediatric clinics in Skåne. The absence of such a general screening entails that mental illness rarely is recognized by medical care providers until it has become severe.
Read more
The purpose of this study is to describe the prevalence of mental illness in children and adolescents, 11-18 years of age, that undergo Medical treatment at a Clinic for children and youth. Groups recruited for the first part of the study are obesity clinics and gastro clinics. In addition, we want to examine if mental health affects outcome success in their medical treatment. The long-term main objective of this project is early discovery and treatment of mental illness in somatically ill children and youth, thereby preventing the development of severe mental illness, and to reduce suffering.
By the end of the project we will have a well-functioning routine for examining mental health status in 11-18 years olds that present for and undergo treatment in Clinics for children and youth in Skåne. Furthermore, we hope that the screening tool can contribute to, and affect, nationally established guide-lines regarding the discovery and treatment of mental illness in children and adolescents within pediatric care.
Read the detailed description
Children and youth, 11-18 years of age, that receive treatment for obesity or Irritable Bowel Disease (IBD), will be asked to fill out three questionnaires on an iPad during a regular visit at their clinic. Information about the study will be sent home before the visit, and will be repeated again at the clinic.
The questionnaires takes about 10-15 minutes in total to answer, and the Child will be able to sit in a separate room while answering. The questionnaires are well validated screening tools for various forms of mental illness; General anxiety disorder 7 item scale (GAD-7) (anxiety), Psycic Health questionnaire 8 items (PHQ-8) (depression), The Child Eating Disorder Examination 8 items (ChEDE-Q8) (eating habits), and Pediatric quality of Life inventory (PedsQL).
Patients that receive high scores will be offered a psychologist appointment for further evaluation and treatment (e. g. individual- or family centered therapy).
- Conditions
- Mental Health Impairment, Obesity, Adolescent, IBD
- Being tested
- Questionnaires
- Keywords
- Mental health, pediatric medicine, obesity, IBD
- Medical subject headings
- Pediatric Obesity, Psychological Well-Being, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
4 questionnaires will be answered via iPads
| Study group | Role | What they receive |
|---|---|---|
| Children and youth at obesity clinic | Children 11-18 who are patients at obesity clinics in region Skåne SUS. Receives: Behavioral: Questionnaires | |
| Children and youth at a pediatric gastrointestinal clinic | Children 11-18 who are patients at a gastrointestinal clinic i region Skåne SUS. Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Eating Disorder Examination-Questionnaire for children (ChEDE-Q8)
Self-reported eating habits Minimum maximum score: 0-6 Total: 48 Better or worse score: 0= never (no problematic eating habits) 6=daily (very problematic eating habits). High svore = very problematic eating habits
Measured: 2020-2022
The psychic health questionnaire 8 items (PHQ-8)
Self-reported signs of depression Minimum maximum score: 0-3 Total: 24 Better or worse score: 0= never (never experiences depressive thoughts) 4=daily (experiences depressive thoughts daily). High score = high levels of depression
Measured: 2020-2022
General anxiety scale 7 items (GAD-7)
Self-reported signs of anxiety Minimum maximum score: 0-3 Total: 21 Better or worse score: 0= never (never experiences anxiety) 4=daily (experiences anxiety daily). High score = excessive feelings of anxiety
Measured: 2020-2022
Pediatric quality of Life scale (PedsQL) 23 items
Self-reported quality of life. Measures feelings of generel well-being Minimum maximum score: 0-4 Total: 92 Better or worse score: 0= never (never experiences well-being) 4=daily (experiences well-being daily). High score = good genereal well-being
Measured: 2020-2022
Changes in ISO-BMI
Measures treatment outcome in obese Children by comparing ISO-BMi levels 1y apart.
Measured: 2021-2022
Changes in F-kalprotectin levels
Measures treatment outcome in Children with iriitable bowel disease (IBD) by comparing levels 1y apart.
Measured: 2021-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Oct 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health ImpairmentStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094324
- Sponsor's protocol ID
- HBG/MMÖ PED2019
- Acronym
- PHU
- Status last verified
- Oct 2023
- First submitted
- 3 Apr 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health in Children and Youth Within Pediatric Care.
- ClinicalTrials.gov ID
- NCT04094324
- Acronym / sponsor ID
- PHU / HBG/MMÖ PED2019
- Conditions
- Mental Health Impairment, Obesity, Adolescent, IBD
- Keywords
- Mental health, pediatric medicine, obesity, IBD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Sep 2019 (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.
Over the last decades, there has been an increase in the number of children and youth with mental illness, such as anxiety and depression. Mental illness in youth has a strong negative influence on the youth's quality of life and generally leads to dysfunction in several important areas, such as school and social activities. Early detection and treatment of mental illness entails great treatment benefits, and thus provide opportunity to prevent or reduce individual suffering.
Youth who suffer från Medical conditions, such as diabetes, epilepsy, gastro-intestinal disease, and obesity, show an increased risk of developing mental illness. There are well-established, careful programs for examining somatic co-morbidities to diseases in children and youth. Currently, despite the fact that mental illness is more common in these children than medical sequelae and despite that such a procedure is recommended, no routine exist for examining mental health in children and youth presenting for treatment at pediatric clinics in Skåne. The absence of such a general screening entails that mental illness rarely is recognized by medical care providers until it has become severe.
The purpose of this study is to describe the prevalence of mental illness in children and adolescents, 11-18 years of age, that undergo Medical treatment at a Clinic for children and youth. Groups recruited for the first part of the study are obesity clinics and gastro clinics. In addition, we want to examine if mental health affects outcome success in their medical treatment. The long-term main objective of this project is early discovery and treatment of mental illness in somatically ill children and youth, thereby preventing the development of severe mental illness, and to reduce suffering.
By the end of the project we will have a well-functioning routine for examining mental health status in 11-18 years olds that present for and undergo treatment in Clinics for children and youth in Skåne. Furthermore, we hope that the screening tool can contribute to, and affect, nationally established guide-lines regarding the discovery and treatment of mental illness in children and adolescents within pediatric care.
Detailed description
Children and youth, 11-18 years of age, that receive treatment for obesity or Irritable Bowel Disease (IBD), will be asked to fill out three questionnaires on an iPad during a regular visit at their clinic. Information about the study will be sent home before the visit, and will be repeated again at the clinic.
The questionnaires takes about 10-15 minutes in total to answer, and the Child will be able to sit in a separate room while answering. The questionnaires are well validated screening tools for various forms of mental illness; General anxiety disorder 7 item scale (GAD-7) (anxiety), Psycic Health questionnaire 8 items (PHQ-8) (depression), The Child Eating Disorder Examination 8 items (ChEDE-Q8) (eating habits), and Pediatric quality of Life inventory (PedsQL).
Patients that receive high scores will be offered a psychologist appointment for further evaluation and treatment (e. g. individual- or family centered therapy).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children and youth at obesity clinic | – | Behavioral: QuestionnairesChildren 11-18 who are patients at obesity clinics in region Skåne SUS. |
| Children and youth at a pediatric gastrointestinal clinic | – | Behavioral: QuestionnairesChildren 11-18 who are patients at a gastrointestinal clinic i region Skåne SUS. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and youth (11-18y) who are patients at a pediatric clinic in Region Skåne SUS (obesity, gatronomy).
Key inclusion criteria (1 listed)
- Children and youth who are patients at a pediatric clinic in Region Skåne SUS(obesity, gatronomy)
Key exclusion criteria (1 listed)
- Children who are unable to reply qustions on an iPad, due to language difficulties or cognitive challenges.
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 |
|---|---|---|
| Questionnaires4 questionnaires will be answered via iPads | Behavioural | Children and youth at a pediatric gastrointestinal clinic, Children and youth at obesity clinic |
Primary outcome
The Eating Disorder Examination-Questionnaire for children (ChEDE-Q8)
Time frame: 2020-2022
Self-reported eating habits Minimum maximum score: 0-6 Total: 48 Better or worse score: 0= never (no problematic eating habits) 6=daily (very problematic eating habits). High svore = very problematic eating habits
The psychic health questionnaire 8 items (PHQ-8)
Time frame: 2020-2022
Self-reported signs of depression Minimum maximum score: 0-3 Total: 24 Better or worse score: 0= never (never experiences depressive thoughts) 4=daily (experiences depressive thoughts daily). High score = high levels of depression
General anxiety scale 7 items (GAD-7)
Time frame: 2020-2022
Self-reported signs of anxiety Minimum maximum score: 0-3 Total: 21 Better or worse score: 0= never (never experiences anxiety) 4=daily (experiences anxiety daily). High score = excessive feelings of anxiety
Pediatric quality of Life scale (PedsQL) 23 items
Time frame: 2020-2022
Self-reported quality of life. Measures feelings of generel well-being Minimum maximum score: 0-4 Total: 92 Better or worse score: 0= never (never experiences well-being) 4=daily (experiences well-being daily). High score = good genereal well-being
Changes in ISO-BMI
Time frame: 2021-2022
Measures treatment outcome in obese Children by comparing ISO-BMi levels 1y apart.
Changes in F-kalprotectin levels
Time frame: 2021-2022
Measures treatment outcome in Children with iriitable bowel disease (IBD) by comparing levels 1y apart.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Impairment and Obesity, Adolescent, run by Region Skane at 2 sites in Sweden.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
The Eating Disorder Examination-Questionnaire for children (ChEDE-Q8) (time frame: 2020-2022). The study lists 6 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 23 Oct 2023.