Mental IllnessNCT02114593
Ladnaan - an Evaluation of a Parent Support Program for Somali Parents
A study testing Parent support program in people with Mental Illness, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of this project is to evaluate the effectiveness of a culturally adapted parenting support program for Somali parents living in Sweden on children's and parent´s mental health. In recent years the Somali population in Sweden has increased and is currently one of the largest groups among ethnic minorities. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Mental Illness
- What is being tested?
- Parent support program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2014to Oct 2015
- Phase
- Interventional
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Somali born parent
- Parent with children in Sweden and in the age 11-16 years old
- Parent with self-perceived stress about parenting
Who cannot join
- parent who is already participating in a parenting program
- Parent with psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Parent Support Program to Promote Somali Parent's and Children's Mental Health
The aim of this project is to evaluate the effectiveness of a culturally adapted parenting support program for Somali parents living in Sweden on children's and parent´s mental health. In recent years the Somali population in Sweden has increased and is currently one of the largest groups among ethnic minorities. Most of the Somali people have arrived as refugees and have experienced war, trauma and conflict. Research shows that migration to a new social context/society is challenging for a family and may together with previous experiences of war, separation, create stress and mental illness. This leads to consequences such as family violence, child abuse, relational problems, drug problems and school problems for children. There is a vast knowledge on the association between parents' mental health, positive parent-child relationship and children's health and well-being. Previous studies have shown that parenting programs aimed to support parent-child relationship and/or improve parental skills have positive effects on parental mental health and on children's behavior. Most municipalities in Sweden offer their residents a structured parenting program, but these programs do not reach those of ethnic minorities. Studies show that parenting programs mainly target parents who can speak Swedish fluently and that the parenting programs are not yet culturally adapted.
Read the detailed description
In recent years the Somali population in Sweden has increased and is currently one of the largest groups among ethnic minorities in Sweden (http://www.scb.se). Most of the Somali people living in Sweden have arrived as refugees and they have experienced war, trauma and conflict. Research shows that migration to a new social context/society is challenging for a family and may together with previous experiences of war, separation, create mental ill-health (Bhugra, 2004; FoU, 2008). According to several studies, refugee families have poorer health and low social status compared to the native Swedish (Bhugra, 2004). Previous studies reported that both parents and children who have experienced war and conflict suffer from stress and are at risk for mental ill-health. This stress leads to various consequences such as family violence, child abuse, relational problems between parents and children, drug problems and school problems for children (Ajdukovic, et al., 1993; James, 1997; Schimtz, et al., 2003). Experience of war and conflict has further shown to have a negative impact on parent's ability to care for their children (Jack, 2000).
There is a vast knowledge on the association between parents' mental health, positive parent-child relationship and children's health and well-being (e.g. Bremberg, 2002). Previous studies have shown that parenting programs aimed to support parent-child relationship and/or improve parental skills have positive effects on parental mental health and on children's behavior (Lindsay et al., 2011; Bjorknes et al., 2013; Stewart-Brown et al., 2011). For example, parents who have participated in parenting programs report feeling less worried, stressed and depressed (Lindsay, et al., 2011; Marcynyszyn, et al., 2011, Phelan, et al., 2012; Stewart-Brown, et al., 2004). Hence, by supporting parents in their role as parents, improvements can be seen in both parents' and children's health and well-being.
According to the Swedish governmental national strategy, parents should be offered support and knowledge on how to strengthen their parenting role (Reports, 2008). Almost all the municipalities in Sweden offer their residents a structured parenting program. However, these parenting programs do not reach all residents in the municipalities, especially those of ethnic minorities (Fabian, et al., 2006; Fabian, et al., 2004), due to language barriers and lack of information about existing parenting programs to the ethnic minorities. Studies show that parenting programs mainly target parents who can speak Swedish fluently and that the parenting programs are not culturally adapted (Kling, et al., 2010). Other international studies emphasize that single or young parents, families with low socioeconomic status or who live in deprived areas, have low attendance and high drop out of parenting program (Byrne, et al., 2013; Stewart-Brown, et al., 2011).
Attempts have been made to culturally adapt parenting programs both in USA, Australia and in Norway. According to (Cardona et al., 2012) cultural adaptation needs to comprise aspects of language, culture and context. In a study by Bjorknes, et al. ( 2013), the cultural adaptation made included not to have mixed groups with both mothers and fathers and to deliver the parenting program with help the of "link workers" of Somali and Pakistani background. While many Somali parents in Sweden do not attend or have no information about the parenting programs that exist in their municipality, the number of participating families might increase substantially if these programs are offered in Somali and are culturally adapted to Somali families' needs.
Aim The aim of the study is to evaluate the effectiveness of a parenting support program on parents' and children's mental health.
Research questions:
- What are the effects of the parenting support program on children's mental health?
- What are effects of the parenting support program on parents' mental health and parents' self-efficacy?
- What is the cost effectiveness of the intervention? Methodological approach: A randomized controlled trial will be conducted with one intervention group (i.e. provision of the Connect parenting program) and one control group (i.e. 'usual activities) consisting of Somali parents living in Borlänge Municipality. When applicable, both parents will be randomized together as one family.
Intervention: the intervention consists of Connect, an already established and scientifically evaluated parent program. The program is based on attachment theory and focuses on the needs of the child/youth and the parent from an attachment perspective. Connect is a 10 week program, which addresses nine different principles on child development, parent-child relationship and challenging interaction. Parents meet together in small groups with a maximum of eight families together with group leaders for one hour sessions each week. In relation to this, parents are offered some beverages and snacks half an hour before the session. Both parents will be invited to the parenting program participation. The intervention will be held in Somali language by group leaders of Somali background. In total eight group leaders will be recruited and receive four days of Connect training course by Connect instructors. Instructors will give also mentorship during parenting program. The program will be proceeded by two sessions (6 hours) on cultural specific challenges, which will be based on the results from the qualitative study (I).
Setting and data collection: Parents will be recruited from the Social services and Somali associations in Borlänge. Several information meetings will be held in different facilities within the social services and Somali associations. Parents who are eligible and give their consent to participate will be asked to fill in the baseline data. Baseline data will be collected before randomization. The intervention will be evaluated by a semi-structured questionnaire. Outcome measures will be collected two and six months after the program has ended in the intervention group, with similar data collection times in the control group. The questionnaires will be translated into the Somali language. They will be filled out by the same parent throughout the study. If both parents participate the intervention their data will pooled if their answer is about the same child. The questionnaires will be answered at a time and location chosen by parents/children, during whom a Somali speaking researcher/person will be present in order to support parents/children in filling out the questionnaires if problems arise (e.g. when parents are illiterate). Outcomes: Primary outcome is improved children's mental health. Secondary outcomes are, improved parents' mental health, and parents' self-efficacy. The questionnaire will include information about the socio-demographic factors and is based on validated instruments.
Sample size and analyzes: A power analysis was conducted to determine the required sample size. When comparing two independent sample means, with alpha set at 0.05, and power at 0.80, we need a total sample of 128 children (I: 64 C: 64) to detect a medium difference (d =.5). These groups will be expanded to 75 per group (a total sample of 150 children) since we expect 20% loss during the follow up. Intention-to-treat will be used. This means that analyses will include all randomized parents in the groups to which they were randomly assigned, regardless of their adherence with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent withdrawal from treatment or deviation from the protocol. The specific statistical analysis used with each outcome variable will be determined by the distribution of the outcome variables. Intergroup comparison will be made between the control group and intervention group.
Significance A number of studies show that many evidence-based parenting programs improve parental skills and parental mental well-being. Parents perceived to be less stressed, depressed and that they have more confident in their parenting role after undergoing parenting program. By evaluating the effectiveness of a culturally appropriate parenting program to Somali parents living in Sweden the project is attempting to contribute to the wellbeing of both children and parents with Somali background. The result will be used to inform stakeholders and policy makers and hopefully be used in other municipalities in Sweden. Furthermore, the results will be disseminated through international conferences and publication in international open-access journals
- Conditions
- Mental Illness
- Being tested
- Parent support program
- Keywords
- Mental Health, Children, Parent support program, Somali families, Sweden
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent support programBehavioural
Parent support program
| Study group | Role | What they receive |
|---|---|---|
| Parent support program | Experimental | Parent support program Receives: Behavioral: Parent support program |
| Standard activities | No intervention | Standard activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's mental health
Child Behavior Checklist, CBCL is a validated instrument for measuring emotional and behavior problems among children. This instrument will be answered by parents.
Measured: 2 months
Secondary outcomes (8)
Parent's mental Health
General Health Questionnaire GHQ12 will be used to measure parent's mental Health.
Measured: 2 months
Parent's sense of competence
Parenting sense of competence,PSOC consists of 16 items to measure efficacy and satisfaction in parenting
Measured: 2 months
Children's mental health
Child Behavior Checklist, CBCL is a validated instrument for measuring emotional and behavior problems among children. This instrument will be answered by Children.
Measured: 6 months
Parent's mental health
General Health Questionnaire GHQ12 will be used to measure parent's mental Health.
Measured: 6 months
Parent's sense of competence
Parenting sense of competence (PSOC) consists of 16 items to measure efficacy and satisfaction in parenting.
Measured: 6 months
Children's mental health
Child Behavior Checklist, CBCL is a validated instrument for measuring emotional and behavior problems among children. This instrument will be answered by Children.
Measured: 2 months
Client satisfaction
Client Satisfaction Questionnaire (CSQ) consists of 10 items to assess and evaluate the intervention and parents' view.
Measured: 2 months
Children's mental health
Child Behavior Checklist, CBCL is a validated instrument for measuring emotional and behavior problem among children. The instrument will be answered by parents.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Dalarna University
- Responsible party
- Principal investigator, Marie Klingberg-Allvin, Karolinska Institutet
- Investigators
- Marie Klingberg-Allvin, Ass. Prof., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114593
- Sponsor's protocol ID
- Ladnaan123
- Other IDs
- Dnr 2014/048
- Status last verified
- Oct 2015
- First submitted
- 12 Apr 2014
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Osman F, Vixner L, Flacking R, Klingberg-Allvin M, Schon UK, Salari R. Impact of a culturally tailored parenting programme on the mental health of Somali parents and children living in Sweden: a longitudinal cohort study. BMJ Open. 2021 Aug 19;11(8):e045067. doi: 10.1136/bmjopen-2020-045067.
PubMed 34413097Nystrand C, Sampaio F, Hoch JS, Osman F, Feldman I. The cost-effectiveness of a culturally tailored parenting program: estimating the value of multiple outcomes. Cost Eff Resour Alloc. 2021 Apr 23;19(1):23. doi: 10.1186/s12962-021-00278-4.
PubMed 33892740Osman F, Salari R, Klingberg-Allvin M, Schon UK, Flacking R. Effects of a culturally tailored parenting support programme in Somali-born parents' mental health and sense of competence in parenting: a randomised controlled trial. BMJ Open. 2017 Dec 7;7(12):e017600. doi: 10.1136/bmjopen-2017-017600.
PubMed 29222136
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Parent Support Program to Promote Somali Parent's and Children's Mental Health
- ClinicalTrials.gov ID
- NCT02114593
- Acronym / sponsor ID
- Ladnaan123
- Conditions
- Mental Illness
- Keywords
- Mental Health, Children, Parent support program, Somali families, Sweden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Dalarna University
- Study start
- Jun 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Apr 2014 (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 project is to evaluate the effectiveness of a culturally adapted parenting support program for Somali parents living in Sweden on children's and parent´s mental health. In recent years the Somali population in Sweden has increased and is currently one of the largest groups among ethnic minorities. Most of the Somali people have arrived as refugees and have experienced war, trauma and conflict. Research shows that migration to a new social context/society is challenging for a family and may together with previous experiences of war, separation, create stress and mental illness. This leads to consequences such as family violence, child abuse, relational problems, drug problems and school problems for children. There is a vast knowledge on the association between parents' mental health, positive parent-child relationship and children's health and well-being. Previous studies have shown that parenting programs aimed to support parent-child relationship and/or improve parental skills have positive effects on parental mental health and on children's behavior. Most municipalities in Sweden offer their residents a structured parenting program, but these programs do not reach those of ethnic minorities. Studies show that parenting programs mainly target parents who can speak Swedish fluently and that the parenting programs are not yet culturally adapted.
Detailed description
In recent years the Somali population in Sweden has increased and is currently one of the largest groups among ethnic minorities in Sweden (http://www.scb.se). Most of the Somali people living in Sweden have arrived as refugees and they have experienced war, trauma and conflict. Research shows that migration to a new social context/society is challenging for a family and may together with previous experiences of war, separation, create mental ill-health (Bhugra, 2004; FoU, 2008). According to several studies, refugee families have poorer health and low social status compared to the native Swedish (Bhugra, 2004). Previous studies reported that both parents and children who have experienced war and conflict suffer from stress and are at risk for mental ill-health. This stress leads to various consequences such as family violence, child abuse, relational problems between parents and children, drug problems and school problems for children (Ajdukovic, et al., 1993; James, 1997; Schimtz, et al., 2003). Experience of war and conflict has further shown to have a negative impact on parent's ability to care for their children (Jack, 2000).
There is a vast knowledge on the association between parents' mental health, positive parent-child relationship and children's health and well-being (e.g. Bremberg, 2002). Previous studies have shown that parenting programs aimed to support parent-child relationship and/or improve parental skills have positive effects on parental mental health and on children's behavior (Lindsay et al., 2011; Bjorknes et al., 2013; Stewart-Brown et al., 2011). For example, parents who have participated in parenting programs report feeling less worried, stressed and depressed (Lindsay, et al., 2011; Marcynyszyn, et al., 2011, Phelan, et al., 2012; Stewart-Brown, et al., 2004). Hence, by supporting parents in their role as parents, improvements can be seen in both parents' and children's health and well-being.
According to the Swedish governmental national strategy, parents should be offered support and knowledge on how to strengthen their parenting role (Reports, 2008). Almost all the municipalities in Sweden offer their residents a structured parenting program. However, these parenting programs do not reach all residents in the municipalities, especially those of ethnic minorities (Fabian, et al., 2006; Fabian, et al., 2004), due to language barriers and lack of information about existing parenting programs to the ethnic minorities. Studies show that parenting programs mainly target parents who can speak Swedish fluently and that the parenting programs are not culturally adapted (Kling, et al., 2010). Other international studies emphasize that single or young parents, families with low socioeconomic status or who live in deprived areas, have low attendance and high drop out of parenting program (Byrne, et al., 2013; Stewart-Brown, et al., 2011).
Attempts have been made to culturally adapt parenting programs both in USA, Australia and in Norway. According to (Cardona et al., 2012) cultural adaptation needs to comprise aspects of language, culture and context. In a study by Bjorknes, et al. ( 2013), the cultural adaptation made included not to have mixed groups with both mothers and fathers and to deliver the parenting program with help the of "link workers" of Somali and Pakistani background. While many Somali parents in Sweden do not attend or have no information about the parenting programs that exist in their municipality, the number of participating families might increase substantially if these programs are offered in Somali and are culturally adapted to Somali families' needs.
Aim The aim of the study is to evaluate the effectiveness of a parenting support program on parents' and children's mental health.
Research questions:
- What are the effects of the parenting support program on children's mental health?
- What are effects of the parenting support program on parents' mental health and parents' self-efficacy?
- What is the cost effectiveness of the intervention? Methodological approach: A randomized controlled trial will be conducted with one intervention group (i.e. provision of the Connect parenting program) and one control group (i.e. 'usual activities) consisting of Somali parents living in Borlänge Municipality. When applicable, both parents will be randomized together as one family.
Intervention: the intervention consists of Connect, an already established and scientifically evaluated parent program. The program is based on attachment theory and focuses on the needs of the child/youth and the parent from an attachment perspective. Connect is a 10 week program, which addresses nine different principles on child development, parent-child relationship and challenging interaction. Parents meet together in small groups with a maximum of eight families together with group leaders for one hour sessions each week. In relation to this, parents are offered some beverages and snacks half an hour before the session. Both parents will be invited to the parenting program participation. The intervention will be held in Somali language by group leaders of Somali background. In total eight group leaders will be recruited and receive four days of Connect training course by Connect instructors. Instructors will give also mentorship during parenting program. The program will be proceeded by two sessions (6 hours) on cultural specific challenges, which will be based on the results from the qualitative study (I).
Setting and data collection: Parents will be recruited from the Social services and Somali associations in Borlänge. Several information meetings will be held in different facilities within the social services and Somali associations. Parents who are eligible and give their consent to participate will be asked to fill in the baseline data. Baseline data will be collected before randomization. The intervention will be evaluated by a semi-structured questionnaire. Outcome measures will be collected two and six months after the program has ended in the intervention group, with similar data collection times in the control group. The questionnaires will be translated into the Somali language. They will be filled out by the same parent throughout the study. If both parents participate the intervention their data will pooled if their answer is about the same child. The questionnaires will be answered at a time and location chosen by parents/children, during whom a Somali speaking researcher/person will be present in order to support parents/children in filling out the questionnaires if problems arise (e.g. when parents are illiterate). Outcomes: Primary outcome is improved children's mental health. Secondary outcomes are, improved parents' mental health, and parents' self-efficacy. The questionnaire will include information about the socio-demographic factors and is based on validated instruments.
Sample size and analyzes: A power analysis was conducted to determine the required sample size. When comparing two independent sample means, with alpha set at 0.05, and power at 0.80, we need a total sample of 128 children (I: 64 C: 64) to detect a medium difference (d =.5). These groups will be expanded to 75 per group (a total sample of 150 children) since we expect 20% loss during the follow up. Intention-to-treat will be used. This means that analyses will include all randomized parents in the groups to which they were randomly assigned, regardless of their adherence with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent withdrawal from treatment or deviation from the protocol. The specific statistical analysis used with each outcome variable will be determined by the distribution of the outcome variables. Intergroup comparison will be made between the control group and intervention group.
Significance A number of studies show that many evidence-based parenting programs improve parental skills and parental mental well-being. Parents perceived to be less stressed, depressed and that they have more confident in their parenting role after undergoing parenting program. By evaluating the effectiveness of a culturally appropriate parenting program to Somali parents living in Sweden the project is attempting to contribute to the wellbeing of both children and parents with Somali background. The result will be used to inform stakeholders and policy makers and hopefully be used in other municipalities in Sweden. Furthermore, the results will be disseminated through international conferences and publication in international open-access journals
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent support program | Experimental | Behavioral: Parent support programParent support program |
| Standard activities | No intervention | –Standard activities |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Somali born parent
- Parent with children in Sweden and in the age 11-16 years old
- Parent with self-perceived stress about parenting
Key exclusion criteria (2 listed)
- parent who is already participating in a parenting program
- Parent with psychiatric disorder
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 |
|---|---|---|
| Parent support programParent support program | Behavioural | Parent support program |
Primary outcome
Children's mental health
Time frame: 2 months
Child Behavior Checklist, CBCL is a validated instrument for measuring emotional and behavior problems among children. This instrument will be answered by parents.
8 secondary outcomes
Parent's mental Health
Time frame: 2 months
Parent's sense of competence
Time frame: 2 months
Children's mental health
Time frame: 6 months
Parent's mental health
Time frame: 6 months
Parent's sense of competence
Time frame: 6 months
Children's mental health
Time frame: 2 months
Client satisfaction
Time frame: 2 months
Children's mental health
Time frame: 6 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 20 Oct 2015.
- Derived from this study: PubMed 34413097Osman F, Vixner L, Flacking R, Klingberg-Allvin M, Schon UK, Salari R. Impact of a culturally tailored parenting programme on the mental health of Somali parents and children living in Sweden: a longitudinal cohort study. BMJ Open. 2021 Aug 19;11(8):e045067. doi: 10.1136/bmjopen-2020-045067.
- Derived from this study: PubMed 33892740Nystrand C, Sampaio F, Hoch JS, Osman F, Feldman I. The cost-effectiveness of a culturally tailored parenting program: estimating the value of multiple outcomes. Cost Eff Resour Alloc. 2021 Apr 23;19(1):23. doi: 10.1186/s12962-021-00278-4.
- Derived from this study: PubMed 29222136Osman F, Salari R, Klingberg-Allvin M, Schon UK, Flacking R. Effects of a culturally tailored parenting support programme in Somali-born parents' mental health and sense of competence in parenting: a randomised controlled trial. BMJ Open. 2017 Dec 7;7(12):e017600. doi: 10.1136/bmjopen-2017-017600.
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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.
Marie Klingberg-Allvin, Ass. Prof. principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent support program in people with Mental Illness, run by Karolinska Institutet 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 3 inclusion and 2 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 20 Oct 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.
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?
Children's mental health (time frame: 2 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 NCT02114593, which also lists 3 linked publications.
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 20 Oct 2015.