Adolescent - Emotional ProblemPhase 3NCT01523561
Influencing Adolescent Girls´ With Creative Dance Twice Weekly
A Phase 3 study testing dance group in people with Adolescent - Emotional Problem, run by Örebro County Council at 1 site in Sweden.
Trial summary
The aim of this study is to evaluate if creative dance twice weekly can influence girls wellbeing. The focus lies on girls 13-18 years old that suffer from repeatedly psychosomatic problems and/or stress. Read more about this study
- Who is it for?
- Ages 13 to 18 years, women only
- Conditions the study is for
- Adolescent - Emotional Problem
- What is being tested?
- dance group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2009to Jan 2013
- Phase
- Phase 3
- 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 13 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- The study population comprised adolescent girls with internalizing problems who had recurrent visits to the school nurse due to psychosomatic symptoms such as:
- pain in the head, stomach, neck, back and/or shoulder.
- persistent feelings of tiredness
- being worried
- in low spirit or depressed were also inclusion criteria.
Who cannot join
- severe hearing impairment
- intellectual disability
- difficulties with the Swedish language or
- if the CAP had advised against participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influencing Adolescent Girls With Internalizing Problems With Creative Dance Twice Weekly. A Randomised, Controlled Study
The aim of this study is to evaluate if creative dance twice weekly can influence girls wellbeing. The focus lies on girls 13-18 years old that suffer from repeatedly psychosomatic problems and/or stress.
Specific objectives are
- To assess the effect of the dance intervention in reducing psychosomatic problems (such as pain in the head, neck, shoulder or stomach), stress and depression
- Determine which factors are important for continuing dancing and keeping up new habits
- A cost-effectiveness analyse of the health outcome.
Geographical area: Örebro County (population 276,000)
Read the detailed description
The school nurses asked girls aged 13-18 years old, who searched for psychosomatic problems, if they wished to participate in the dance project. Recruitment of girls where also carried out in information about the project at parent meetings and in school classrooms. 143 girls completed the base-line questionnaire, 138 met the inclusion criteria and were included. Randomization was carried out to intervention and control group.
The quantitative data collection is carried out with a questionnaire. Participants in the dance intervention and the control group will response to this questionnaire at 7 times during the study, at start and every six months over a total period of 3 years.
Girls who are found to be at risk of having severe depression (> 34 points) in the depression scale CES-DC met with an experienced licensed psychologist. This was to explore if there was a need for extended support and help and the girl's parents and Child and Adolescent Psychiatric Care was contacted in most cases and if there was a risk for suicide. The results from the depression scale at base - line (CES-DC) showed that 81% of the girls in the study had depressive symptoms and 29% had high levels of depressive symptoms.
The qualitative interviews were performed in order to explore the girls experience of the dance lessons and to assess if and/or how dance intervention has affected her self-esteem in any way. These interviews were conducted on a strategic sample of 20 girls who participated in the dance intervention.
The dance intervention took place in a gym in Örebro twice weekly for a period of 1 year under the guidance of two dance class teachers (one at a time). The duration of the class was 75 minutes and the dance training was always carried out to popular and suitable music. The dance choreography was adjusted to the level of the participants' skills in order to make them feel successful in their exercise. During the intervention year, the theme of dance styles varied from hip hop, jazz, aerobic dance and contemporary dance. African dance, to the music of African drums, was used in the warm up section. The dance class always ended with a 10-min-relaxation training. The dance intervention had a strong focus on emphasizing the participants' resources and creates a feeling of affinity. The dance teachers encouraged them to listen to signals from the body, reducing focus on the performance and "become part of the movement".
- Conditions
- Adolescent - Emotional Problem
- Being tested
- dance group
- Keywords
- dance, intervention, adolescent, girls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dance groupBehavioural
The dance intervention took place twice weekly for a period of 1 year under the guidance of two dance class teachers. The duration of the class was 75 min. and the dance training was always carried out to popular music. The dance choreography was adjusted to the level of the participants' skills in order to make them feel successful in their exercise. During the intervention year, the theme of dance styles varied from hip hop, jazz and contemporary dance. African dance was used in the warm up section. The dance class always ended with a relaxation. The dance intervention had a focus on emphasizing the participants' resources and creates a feeling of affinity. Listening to signals from the body, reducing focus on the performance and "become part of the movement" was encouraged.
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | The participants in the no intervention group were informed that they should continue living as usual |
| dance intervention | Experimental | The dance intervention took place twice weekly for a period of 1 year under the guidance of two dance class teachers. The duration of the class was 75 min. and the dance training was always carried out to popular music. The dance choreography was adjusted to the level of the participants' skills in order to make them feel successful in their exercise. During the intervention year, the theme of dance styles varied from hip hop, jazz and contemporary dance. African dance was used in the warm up section. The dance class always ended with a relaxation. The dance intervention had a focus on emphasizing the participants' resources and creates a feeling of affinity. Listening to signals from the body, reducing focus on the performance and "become part of the movement" was encouraged. Receives: Behavioral: dance group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported health
the single-item question "How do you rate your general health?" is frequently used in national and international surveys. The response alternatives is 1. Very poor, 2. Poor, 3. Neither good nor poor, 4. Good, 5. Very good. Measuring general health with a five-degree scale has been agreed upon in the EU.
Measured: change from baseline to follow up at 20 months
Secondary outcomes (1)
adherence to and experience of the intervention
The adherence to the dance intervention was measured by registering attendance at every dance session during the intervention period. Cancellations were made by telephone or text message.The experience of the dance intervention was evaluated with a graphic rating scale, a modified Visual Analogue Scale with five discrete alternatives.The question was "How do you experience dancing while you perform it?"; the rating scale started at "entirely negative" and ended at "entirely positive." Cut-off was set between "neutral" and "entirely positive".
Measured: change baseline to follow up at 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startOct 2009
- Primary completionMay 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent - Emotional ProblemStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Margareta Moller, Region Örebro County
- Investigators
- Margareta HL Moller, professor, Principal investigator, Örebro County Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523561
- Sponsor's protocol ID
- MMO027
- Status last verified
- Jul 2015
- First submitted
- 18 Jan 2012
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Philipsson A, Duberg A, Moller M, Hagberg L. Cost-utility analysis of a dance intervention for adolescent girls with internalizing problems. Cost Eff Resour Alloc. 2013 Feb 20;11(1):4. doi: 10.1186/1478-7547-11-4.
PubMed 23425608
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Adolescent Girls With Internalizing Problems With Creative Dance Twice Weekly. A Randomised, Controlled Study
- ClinicalTrials.gov ID
- NCT01523561
- Acronym / sponsor ID
- MMO027
- Conditions
- Adolescent - Emotional Problem
- Keywords
- dance, intervention, adolescent, girls
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Örebro County CouncilOther government
- Study start
- Oct 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 1 Feb 2012 (estimated)
- 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.
The aim of this study is to evaluate if creative dance twice weekly can influence girls wellbeing. The focus lies on girls 13-18 years old that suffer from repeatedly psychosomatic problems and/or stress.
Specific objectives are
- To assess the effect of the dance intervention in reducing psychosomatic problems (such as pain in the head, neck, shoulder or stomach), stress and depression
- Determine which factors are important for continuing dancing and keeping up new habits
- A cost-effectiveness analyse of the health outcome.
Geographical area: Örebro County (population 276,000)
Detailed description
The school nurses asked girls aged 13-18 years old, who searched for psychosomatic problems, if they wished to participate in the dance project. Recruitment of girls where also carried out in information about the project at parent meetings and in school classrooms. 143 girls completed the base-line questionnaire, 138 met the inclusion criteria and were included. Randomization was carried out to intervention and control group.
The quantitative data collection is carried out with a questionnaire. Participants in the dance intervention and the control group will response to this questionnaire at 7 times during the study, at start and every six months over a total period of 3 years.
Girls who are found to be at risk of having severe depression (> 34 points) in the depression scale CES-DC met with an experienced licensed psychologist. This was to explore if there was a need for extended support and help and the girl's parents and Child and Adolescent Psychiatric Care was contacted in most cases and if there was a risk for suicide. The results from the depression scale at base - line (CES-DC) showed that 81% of the girls in the study had depressive symptoms and 29% had high levels of depressive symptoms.
The qualitative interviews were performed in order to explore the girls experience of the dance lessons and to assess if and/or how dance intervention has affected her self-esteem in any way. These interviews were conducted on a strategic sample of 20 girls who participated in the dance intervention.
The dance intervention took place in a gym in Örebro twice weekly for a period of 1 year under the guidance of two dance class teachers (one at a time). The duration of the class was 75 minutes and the dance training was always carried out to popular and suitable music. The dance choreography was adjusted to the level of the participants' skills in order to make them feel successful in their exercise. During the intervention year, the theme of dance styles varied from hip hop, jazz, aerobic dance and contemporary dance. African dance, to the music of African drums, was used in the warm up section. The dance class always ended with a 10-min-relaxation training. The dance intervention had a strong focus on emphasizing the participants' resources and creates a feeling of affinity. The dance teachers encouraged them to listen to signals from the body, reducing focus on the performance and "become part of the movement".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –The participants in the no intervention group were informed that they should continue living as usual |
| dance intervention | Experimental | Behavioral: dance groupThe dance intervention took place twice weekly for a period of 1 year under the guidance of two dance class teachers. The duration of the class was 75 min. and the dance training was always carried out to popular music. The dance choreography was adjusted to the level of the participants' skills in order to make them feel successful in their exercise. During the intervention year, the theme of dance styles varied from hip hop, jazz and contemporary dance. African dance was used in the warm up section. The dance class always ended with a relaxation. The dance intervention had a focus on emphasizing the participants' resources and creates a feeling of affinity. Listening to signals from the body, reducing focus on the performance and "become part of the movement" was encouraged. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- The study population comprised adolescent girls with internalizing problems who had recurrent visits to the school nurse due to psychosomatic symptoms such as:
Key exclusion criteria (4 listed)
- severe hearing impairment
- intellectual disability
- difficulties with the Swedish language or
- if the CAP had advised against participation.
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 |
|---|---|---|
| dance groupThe dance intervention took place twice weekly for a period of 1 year under the guidance of two dance class teachers. The duration of the class was 75 min. and the dance training was always carried out to popular music. The dance choreography was adjusted to the level of the participants' skills in order to make them feel successful in their exercise. During the intervention year, the theme of dance styles varied from hip hop, jazz and contemporary dance. African dance was used in the warm up section. The dance class always ended with a relaxation. The dance intervention had a focus on emphasizing the participants' resources and creates a feeling of affinity. Listening to signals from the body, reducing focus on the performance and "become part of the movement" was encouraged. | Behavioural | dance intervention |
Primary outcome
Self reported health
Time frame: change from baseline to follow up at 20 months
the single-item question "How do you rate your general health?" is frequently used in national and international surveys. The response alternatives is 1. Very poor, 2. Poor, 3. Neither good nor poor, 4. Good, 5. Very good. Measuring general health with a five-degree scale has been agreed upon in the EU.
1 secondary outcome
adherence to and experience of the intervention
Time frame: change baseline to follow up at 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Derived from this study: PubMed 23425608Philipsson A, Duberg A, Moller M, Hagberg L. Cost-utility analysis of a dance intervention for adolescent girls with internalizing problems. Cost Eff Resour Alloc. 2013 Feb 20;11(1):4. doi: 10.1186/1478-7547-11-4.
- The centers goal is to heighten the scientific competence within the Örebro county through stimulation, initiation and support for research and developement projects.Link provided by the sponsor.
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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.
Margareta HL Moller, professor principal investigator
Örebro County Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dance group in people with Adolescent - Emotional Problem, run by Örebro County Council at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self reported health (time frame: change from baseline to follow up at 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01523561, which also lists 1 linked publication.
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 15 Jul 2015.