Substance Use DisordersA-CRA at SiSNCT06094972
The Effectiveness of A-CRA in Compulsory Institutional Care for Youth
A study testing Adolescent Community Reinforcement Approach, A-CRA and TAU in people with Substance Use Disorders and Criminal Behavior, run by Karolinska Institutet at 4 sites in Sweden.
Trial summary
Youth with substance use disorder (SUD) and socially disruptive behaviour (such as criminality) who are placed in compulsory institutional care are at high risk of continuing a destructive lifestyle into adulthood. There is a pressing need for effective treatment for this group, yet studies are scarce. Read more about this study
- Who is it for?
- Ages 16 to 21 years
- Conditions the study is for
- Substance Use Disorders, Criminal Behavior
- What is being tested?
- Adolescent Community Reinforcement Approach, A-CRA and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 4 sitesSweden
- Study dates
- 15 Sep 2023to 30 Dec 2025
- 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 16 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 16-21
- Placed in institutional care
- Suffers from SUD and socially disruptive behaviour
- Ability to read and understand informed consent and interventions
Who cannot join
- Severe cognitive or psychiatric condition preventing the ability to provide informed consent or undergo assessment or interventions
- Serious somatic condition requiring acute medical attention
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites, 4 recruiting
- Recruiting
Sundbo
Fagersta, Västmanland County
Maria Lambertsson, maria.lambertsson@stat-inst.se
- Recruiting
Statens institutionsstyrelse, SiS, Johannisberg
Kalix
Stefan Granström
- Recruiting
Fagersta
Lindome, Västra Götaland County
Kristina Schultz
- Recruiting
Statens institutionsstyrelse, SiS, Ljungbacken
Uddevalla
Lisa Lidström, Msc
About this study
Official title: The Effectiveness of A-CRA in Compulsory Institutional Care for Youth - an Independent Randomized Controlled Trial
Youth with substance use disorder (SUD) and socially disruptive behaviour (such as criminality) who are placed in compulsory institutional care are at high risk of continuing a destructive lifestyle into adulthood. There is a pressing need for effective treatment for this group, yet studies are scarce. The empirically supported SUD treatment Adolescent Community Reinforcement Approach, A-CRA, promotes long-term abstinence, increases social stability and decreases co-morbid psychiatric problems for youth ages 12-25. A-CRA is proven to be one of the most effective SUD treatments for youth but has only been evaluated in outpatient care. Given A-CRA's promising results for youth in vulnerable living situations, it is a reasonable treatment to adjust and evaluate in compulsory care. The main objectives are to evaluate the effectiveness of A-CRA, the short- and long-term effects on social-, emotional- and problem behavior and substance use, for youth placed in compulsory institutional care.
Read the detailed description
Substance abuse and criminality among youth in Sweden are urgent problems. More knowledge on effective interventions is crucial to help vulnerable youth at risk of developing an array of severe problems affecting both themselves, their relatives and society (Grahn, Lundgren Chassler \& Padyab, 2015). Effective help for substance abuse increases chances to abandon criminality and build up a constructive life (Henderson et al, 2016, Chermack et al, 2010). Youth with severe substance abuse and psychosocial problems, such as criminal and socially disruptive behavior, often receive treatment in compulsory institutional care. The responsible party for delivering care in this domain is The Swedish National Board of Institutional Care, (Statens institutionsstyrelse, SiS). SiS provides institutional care on basis of the Swedish laws Care of Young Persons (Special Provisions) Act, LVU, Care of Substance Abusers (Special Provisions) Act, LVM, Secure Youth Care Act, LSU. Treatment is delivered in lockable institutions, situated in different locations around the country. However, the institutional setting differs from standard outpatient care where most substance use treatments have been designed for. For example, the locked ward and security routines pose challenges when fostering pro-social and constructive behavior (Gevers, Poelen, Scholte, Otten \& Koordeman, 2020). Every activity must be thoroughly planned to lower risks of violence or escaping and routines, such as visitations, can lower the ability and motivation to engage in positive activities outside the institution (Brauers, Kroneman, Otten, Lindauer \& Popma, 2016). The Swedish Agency for Health Technology Assessment and Assessment of Social Services, SBU, concluded in a systematic review (2016) that the scientific support for several of the treatment programs conducted at SiS are inadequate. Consequently, that more research on treatment in institutional care is needed, especially high-quality studies with a study design adjusted to the specific conditions prevailing there.
An empirically supported substance use treatment developed for youth ages twelve to twenty five is the Adolescent Community Reinforcement Approach, A-CRA. A-CRA promotes long-term abstinence, increase social stability and decrease depression and other co-morbid psychiatric problems according to a large number of studies since the nineteen seventies (Azrin, Sisson, Meyers, \& Godley, 1982; Dennis et al., 2004; Hunt \& Azrin, 1973; Godley et al., 2014; Godley et al., 2001; Godley, Smith, Passetti, \& Subramaniam, 2014). A-CRA is recommended in national guidelines for the treatment of substance use disorder in adolescents (Socialstyrelsen, 2017). Treatment consists of eighteen procedures that aim to reduce problematic behaviors and increase constructive behaviors. Example of procedures are happiness scale and treatment goals, functional analysis of substance use behavior, increasing prosocial activities, drink/drug refusal, relapse prevention, communication skills, caregiver sessions, job seeking skills and anger management (Godley, Smith, Myers \& Godley, 2016). Procedures are combined and tailored to youth individual goals and needs (Godley et al., 2016). A-CRA has also proven helpful for justice-involved youth with substance use disorder under probation (Henderson et al. 2016) and for homeless youth (Slesnick et al., 2007). However, as many other psychological treatments, A-CRA has mostly been delivered and evaluated within outpatient care. It is unclear whether A-CRA is as effective when delivered in compulsory care where many adolescents with severe substance use disorder and criminal behavior receive treatment.
The overall objective of this research project is to scientifically evaluate the effectiveness of A-CRA in compulsory institutional care for youth with substance use disorder and criminal behavior. In addition, to explore mechanisms of change, what mediates substance abuse and criminal behavior.
Youth are randomized to either treatment as usual or treatment as usual with the addition of A-CRA. Treatment as usual is defined as the interventions and treatments adolescents are usually offered and undergo in institutional care. These are Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. Randomization takes place at site level with even allocation to the groups. Quantitative measurements take place before, during and after treatment as well as follow-up at 1, 3, 6 and 12 months. Primary endpoint is 6 months after treatment completion. Qualitative data will be collected by interviewing participants at 3 month follow-up. Potential adverse events will be collected after treatment completion using open questions and registered when reported by staff in the research group or at KI.
- Conditions
- Substance Use Disorders, Criminal Behavior
- Being tested
- Adolescent Community Reinforcement Approach, A-CRA, TAU
- Medical subject headings
- Substance-Related Disorders, Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent Community Reinforcement Approach, A-CRABehavioural
A-CRA consists of eighteen treatment modules/procedures that is delivered in weekly sessions over 12-14 weeks. The overarching goal is to decrease substance use behaviours and other related, problematic behaviours such as acting out when experiencing anger, and to increase prosocial and sober behaviours, relationships and activities. The procedures are: 1) Introduction to A-CRA/treatment agreement, 2) Happiness scale and treatment goals, 3) Homework, 4) Systematic encouragement, 5) Functional analysis of substance use behaviour, 6) Functional analysis of prosocial/sober behaviour, 7) Increasing prosocial activities, 8) Drink/drug refusal, 9) Relapse prevention, 10) Sobriety sampling, 11) Communication skills, 12) Problem-solving, 13) Caregiver sessions, 14) Relationship skills, 15) Couple relationship skills, 16) Job-seeking skills, 17) Anger management, 18) Medication adherence and monitoring. Youths' individual goals and problems guide treatment planning.
TAUBehavioural
Standard care is defined as the interventions and treatments adolescents are usually offered and undergo in institutional care in Sweden. These are Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT and PULS, a program for reducing violence and criminal behavior. Also, individually tailored interventions will be included, such as counselling or other psychological interventions. TAU will be thoroughly registered during the study since the sites in the trial differs slightly in what they offer.
| Study group | Role | What they receive |
|---|---|---|
| TAU + A-CRA | Experimental | TAU: Interventions and treatments usually offered and delivered in institutional care. See below for examples.
12-14 weekly sessions of A-CRA, a behavioral treatment for youth suffering from substance use disorder and co-occurring problems. Treatment consists of 18 procedures that aim to reduce problematic behaviors and increase constructive behaviors. Examples of procedures are functional analysis of substance use behavior, functional analysis of prosocial behavior, increasing prosocial activities, drink/drug refusal, relapse prevention, anger management and caregiver sessions. Procedures are combined and tailored to meet youth individual goals and needs. Receives: Behavioral: Adolescent Community Reinforcement Approach, A-CRA |
| TAU | Active comparator | Standard care is defined as the interventions and treatments adolescents are usually offered and undergo in institutional care. These are Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. This will be further specified and registered in the initial phase of the study, in collaboration with SiS. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social, emotional and behavioural problems
Measured using the Strengths and Difficulties Questionnaire
Measured: 0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, and 12 months after treatment completion
Secondary outcomes (7)
Self reported substance use
Self-reported substance use, five questions
Measured: 0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, 12 months after treatment
Use of alcohol
AUDIT - Alcohol Use Disorders Identification Test (Saunders et al, 1993)
Measured: 0 weeks, 14 weeks and at follow-up 1, 6 and 12 months after treatment completio
Use of illegal drugs
Drug Use Disorders Identification Test (DUDIT; Berman, Bergman, Palmstierna, \& Schlyter, 2005)
Measured: 0 weeks, 14 weeks and at follow-up 1, 6 and 12 months after treatment completion
Number of days until the first relapse
Self-reported substance use, five questions
Measured: 0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6 and 12 months after treatment completion
Aggressive behavior
Measured using the Bröset Violent Checklist (Koskela, 2012)
Measured: 0 weeks, 7 weeks and 14 weeks and at follow-up 1 month after treatment completion
Goal directed behavior and values
Bull's-Eye Values Survey (BEVS; Lundgren et al., 2012)
Measured: 0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, 12 months after treatment
Psychological flexibility
Avoidance and Fusion Questionnaire Short Version (AFQ-Y8; Livheim et al.,2016)
Measured: 0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start15 Sep 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Lundgren, Karolinska Institutet
- Investigators
- Tobias Lundgren, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094972
- Sponsor's protocol ID
- 2022-06079-01
- Acronym
- A-CRA at SiS
- Status last verified
- Feb 2024
- First submitted
- 17 Oct 2023
- Last updated
- 5 Feb 2024
- 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 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of A-CRA in Compulsory Institutional Care for Youth - an Independent Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06094972
- Acronym / sponsor ID
- A-CRA at SiS / 2022-06079-01
- Conditions
- Substance Use Disorders, Criminal Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 23 Oct 2023 (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.
Youth with substance use disorder (SUD) and socially disruptive behaviour (such as criminality) who are placed in compulsory institutional care are at high risk of continuing a destructive lifestyle into adulthood. There is a pressing need for effective treatment for this group, yet studies are scarce. The empirically supported SUD treatment Adolescent Community Reinforcement Approach, A-CRA, promotes long-term abstinence, increases social stability and decreases co-morbid psychiatric problems for youth ages 12-25. A-CRA is proven to be one of the most effective SUD treatments for youth but has only been evaluated in outpatient care. Given A-CRA's promising results for youth in vulnerable living situations, it is a reasonable treatment to adjust and evaluate in compulsory care. The main objectives are to evaluate the effectiveness of A-CRA, the short- and long-term effects on social-, emotional- and problem behavior and substance use, for youth placed in compulsory institutional care.
Detailed description
Substance abuse and criminality among youth in Sweden are urgent problems. More knowledge on effective interventions is crucial to help vulnerable youth at risk of developing an array of severe problems affecting both themselves, their relatives and society (Grahn, Lundgren Chassler \& Padyab, 2015). Effective help for substance abuse increases chances to abandon criminality and build up a constructive life (Henderson et al, 2016, Chermack et al, 2010). Youth with severe substance abuse and psychosocial problems, such as criminal and socially disruptive behavior, often receive treatment in compulsory institutional care. The responsible party for delivering care in this domain is The Swedish National Board of Institutional Care, (Statens institutionsstyrelse, SiS). SiS provides institutional care on basis of the Swedish laws Care of Young Persons (Special Provisions) Act, LVU, Care of Substance Abusers (Special Provisions) Act, LVM, Secure Youth Care Act, LSU. Treatment is delivered in lockable institutions, situated in different locations around the country. However, the institutional setting differs from standard outpatient care where most substance use treatments have been designed for. For example, the locked ward and security routines pose challenges when fostering pro-social and constructive behavior (Gevers, Poelen, Scholte, Otten \& Koordeman, 2020). Every activity must be thoroughly planned to lower risks of violence or escaping and routines, such as visitations, can lower the ability and motivation to engage in positive activities outside the institution (Brauers, Kroneman, Otten, Lindauer \& Popma, 2016). The Swedish Agency for Health Technology Assessment and Assessment of Social Services, SBU, concluded in a systematic review (2016) that the scientific support for several of the treatment programs conducted at SiS are inadequate. Consequently, that more research on treatment in institutional care is needed, especially high-quality studies with a study design adjusted to the specific conditions prevailing there.
An empirically supported substance use treatment developed for youth ages twelve to twenty five is the Adolescent Community Reinforcement Approach, A-CRA. A-CRA promotes long-term abstinence, increase social stability and decrease depression and other co-morbid psychiatric problems according to a large number of studies since the nineteen seventies (Azrin, Sisson, Meyers, \& Godley, 1982; Dennis et al., 2004; Hunt \& Azrin, 1973; Godley et al., 2014; Godley et al., 2001; Godley, Smith, Passetti, \& Subramaniam, 2014). A-CRA is recommended in national guidelines for the treatment of substance use disorder in adolescents (Socialstyrelsen, 2017). Treatment consists of eighteen procedures that aim to reduce problematic behaviors and increase constructive behaviors. Example of procedures are happiness scale and treatment goals, functional analysis of substance use behavior, increasing prosocial activities, drink/drug refusal, relapse prevention, communication skills, caregiver sessions, job seeking skills and anger management (Godley, Smith, Myers \& Godley, 2016). Procedures are combined and tailored to youth individual goals and needs (Godley et al., 2016). A-CRA has also proven helpful for justice-involved youth with substance use disorder under probation (Henderson et al. 2016) and for homeless youth (Slesnick et al., 2007). However, as many other psychological treatments, A-CRA has mostly been delivered and evaluated within outpatient care. It is unclear whether A-CRA is as effective when delivered in compulsory care where many adolescents with severe substance use disorder and criminal behavior receive treatment.
The overall objective of this research project is to scientifically evaluate the effectiveness of A-CRA in compulsory institutional care for youth with substance use disorder and criminal behavior. In addition, to explore mechanisms of change, what mediates substance abuse and criminal behavior.
Youth are randomized to either treatment as usual or treatment as usual with the addition of A-CRA. Treatment as usual is defined as the interventions and treatments adolescents are usually offered and undergo in institutional care. These are Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. Randomization takes place at site level with even allocation to the groups. Quantitative measurements take place before, during and after treatment as well as follow-up at 1, 3, 6 and 12 months. Primary endpoint is 6 months after treatment completion. Qualitative data will be collected by interviewing participants at 3 month follow-up. Potential adverse events will be collected after treatment completion using open questions and registered when reported by staff in the research group or at KI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU + A-CRA | Experimental | Behavioral: Adolescent Community Reinforcement Approach, A-CRATAU: Interventions and treatments usually offered and delivered in institutional care. See below for examples. 12-14 weekly sessions of A-CRA, a behavioral treatment for youth suffering from substance use disorder and co-occurring problems. Treatment consists of 18 procedures that aim to reduce problematic behaviors and increase constructive behaviors. Examples of procedures are functional analysis of substance use behavior, functional analysis of prosocial behavior, increasing prosocial activities, drink/drug refusal, relapse prevention, anger management and caregiver sessions. Procedures are combined and tailored to meet youth individual goals and needs. |
| TAU | Active comparator | Behavioral: TAUStandard care is defined as the interventions and treatments adolescents are usually offered and undergo in institutional care. These are Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. This will be further specified and registered in the initial phase of the study, in collaboration with SiS. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 16-21
- Placed in institutional care
- Suffers from SUD and socially disruptive behaviour
- Ability to read and understand informed consent and interventions
Key exclusion criteria (2 listed)
- Severe cognitive or psychiatric condition preventing the ability to provide informed consent or undergo assessment or interventions
- Serious somatic condition requiring acute medical attention
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 |
|---|---|---|
| Adolescent Community Reinforcement Approach, A-CRAA-CRA consists of eighteen treatment modules/procedures that is delivered in weekly sessions over 12-14 weeks. The overarching goal is to decrease substance use behaviours and other related, problematic behaviours such as acting out when experiencing anger, and to increase prosocial and sober behaviours, relationships and activities. The procedures are: 1) Introduction to A-CRA/treatment agreement, 2) Happiness scale and treatment goals, 3) Homework, 4) Systematic encouragement, 5) Functional analysis of substance use behaviour, 6) Functional analysis of prosocial/sober behaviour, 7) Increasing prosocial activities, 8) Drink/drug refusal, 9) Relapse prevention, 10) Sobriety sampling, 11) Communication skills, 12) Problem-solving, 13) Caregiver sessions, 14) Relationship skills, 15) Couple relationship skills, 16) Job-seeking skills, 17) Anger management, 18) Medication adherence and monitoring. Youths' individual goals and problems guide treatment planning. | Behavioural | TAU + A-CRA |
| TAUStandard care is defined as the interventions and treatments adolescents are usually offered and undergo in institutional care in Sweden. These are Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT and PULS, a program for reducing violence and criminal behavior. Also, individually tailored interventions will be included, such as counselling or other psychological interventions. TAU will be thoroughly registered during the study since the sites in the trial differs slightly in what they offer. | Behavioural | TAU |
Primary outcome
Social, emotional and behavioural problems
Time frame: 0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, and 12 months after treatment completion
Measured using the Strengths and Difficulties Questionnaire
7 secondary outcomes
Self reported substance use
Time frame: 0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, 12 months after treatment
Use of alcohol
Time frame: 0 weeks, 14 weeks and at follow-up 1, 6 and 12 months after treatment completio
Use of illegal drugs
Time frame: 0 weeks, 14 weeks and at follow-up 1, 6 and 12 months after treatment completion
Number of days until the first relapse
Time frame: 0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6 and 12 months after treatment completion
Aggressive behavior
Time frame: 0 weeks, 7 weeks and 14 weeks and at follow-up 1 month after treatment completion
Goal directed behavior and values
Time frame: 0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, 12 months after treatment
Psychological flexibility
Time frame: 0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- 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.
Tobias Lundgren, PhD principal investigator
Karolinska Institutet
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adolescent Community Reinforcement Approach, A-CRA and TAU in people with Substance Use Disorders and Criminal Behavior, run by Karolinska Institutet at 4 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 4 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: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Contact Tobias Lundgren, PhD (070-612 45 55, tobias.lundgren@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social, emotional and behavioural problems (time frame: 0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, and 12 months after treatment completion). 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 5 Feb 2024.