Attention Deficit and Disruptive Behavior DisordersBPTTNCT03967509
Effectiveness of Behavioral Preschool Teacher Training for Externalizing
A study testing Comet in people with Attention Deficit and Disruptive Behavior Disorders and Problem Behavior, run by Uppsala University at 1 site in Sweden.
Trial summary
A cluster randomized controlled pre-post effectiveness trial of behavioral preschool teacher training (BPTT) delivered in a practitioner assisted group format for children with externalizing behavior problems. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Attention Deficit and Disruptive Behavior Disorders, Problem Behavior, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Comet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 18 Aug 2008to 3 Feb 2011
- 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elevated level of externalizing behavior
- Exceeding cutoff value 11 on the Strengths and Difficulties Questionnaire, total scale
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Cluster Randomized Comet-program Behavioral Preschool Teacher Training in Reducing Externalizing Behavior
A cluster randomized controlled pre-post effectiveness trial of behavioral preschool teacher training (BPTT) delivered in a practitioner assisted group format for children with externalizing behavior problems. Preschools were randomized to either intervention in 25 preschools or as 22 waiting list control preschools, where teachers in preschool classes with the target child or children were program receivers. Participants were 100 target children 3-5 years old together with 72 enrolled preschool teachers and 83 parents as informants of behavioral outcomes after a five months period of implementation (at six months). The intervention was part of the Swedish evidence-based parent and teacher training programs (Comet) for children and youth with elevated externalizing behavior, and here an adapted version was tried in preschool for the first time. Also investigated was eventual generalized effects to the children's homes and improved social competence as an intermediate mechanism for reduced problem behavior. Effects of implementation fidelity in addition to social acceptability and relevance, such as reliable change, was investigated as well.
Read the detailed description
Study:
A cluster randomized controlled pre-post effectiveness trial of behavioral preschool teacher training (BPTT) delivered in a practitioner assisted group format for children with externalizing behavior problems. Preschools were randomized to either intervention in 25 preschools or to 22 waiting list control preschools, where preschool classes with the target child or children were program receivers. Informed preschools could apply for participation in the study, then, target children were screened for eligibility. Participants were 100 target children 3-5 years old together with 72 enrolled preschool teachers and 83 parents as informants of behavioral outcomes after a five months period of implementation (at six months).
Intervention:
The intervention was part of the Swedish evidence-based parent and teacher training programs (COmmunication METhod - Comet) for children and youths aged 3-12 and 12-18 years with moderate or elevated externalizing behavior, usually delivered in practitioner assisted group formats but previously evaluated as delivered via internet, single workshops followed by self-administered training, and universal prevention as well. Program implementations and evaluations are executed as collaboration projects between university researchers and the social services administration at place. Intervention content is influenced by operant conditioning, social learning theories, applied behavior analysis, and coercion theory. The focus is to establish a positive and effective interaction and communication style primarily through different reinforcement techniques (e.g., selective attention, more to positive behaviors and less to negative behaviors) and modeling. Parents or teachers meet in psychoeducational group sessions (often 9 to 11 sessions à 2.5 to 3 hours) led by one or two practitioner supervisors. They each follow a comprehensive manual and a highly structured curriculum. Training occurs at sessions (role-plays) and between sessions together with the children, followed-up with feedback in the next session.
Here an adapted version was tried in the preschool setting for the first time. The program corresponded in much to the parent training supplemented with techniques from the school teacher training and a group level administrated glove-puppet play technique to foster children's prosocial skills. (Results from the universal part of the program are not reported.) The nine sessions curriculum consisted of 2.5-hour biweekly meetings and two optional visits from supervisors with coaching on the spot. Practitioner supervisors (n = 27) were educated by a cognitive-behavior oriented psychologist during five days term one and two days term two.
Investigation issues:
The primary aim was to investigate behavioral outcome effects of the preschool teacher program. Would effects (Cohen's d) be in the medium-large range as found for Comet parent training (i.e., d = .50-.90) or in the small-medium range as often found for preventive developmental preschool programs (i.e., d = .20-.40)? With effects of about .40, a sample size restricted to 100 subjects, and an alpha at .05, power would be close to sufficient (i.e., .70). Of interest was to compare the effects of this program with effects found for other preschool program investigations of externalizing behavior problems.
Also investigated was eventual generalized effects to the children's homes. Of what magnitude would such effects be, if any, and would the parents' ratings validate the teachers' ratings, and thus, support the intervention? Such effects may have implications for future implementations, for example if the program is sufficiently efficient as a stand-alone intervention in reducing externalizing behavior problems or not sufficiently efficient. There was also a question of degree of informants agreement/discrepancy. Furthermore, would improved prosocial and regulatory skills function as a predictive and an intermediate mechanism for reduced problem behavior, and/or would there be room for other intervention features to contribute as well? In addition, as a trial in the real world, effects of implementation fidelity as well as social acceptability and relevance, such as proportions of children with reliable change, were investigated.
- Conditions
- Attention Deficit and Disruptive Behavior Disorders, Problem Behavior, Attention Deficit Disorder With Hyperactivity
- Being tested
- Comet
- Keywords
- Externalizing behavior problems, Social competence, School readiness, Teacher management training, Cluster randomized effectiveness trial
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders, Problem Behavior, Attention Deficit Disorder with Hyperactivity, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CometBehavioural
Also called Comet in group format
| Study group | Role | What they receive |
|---|---|---|
| Behavioral teacher training | Experimental | Behavioral preschool teacher training (BPTT) delivered in an educational group format during nine 2,5-hour biweekly sessions with training at sessions and in between followed by supervisor's feedback on the practice and two optional coaching occasions on the spot. Receives: Behavioral: Comet |
| Waiting list control group | No intervention | Preschool teachers worked with children as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sutter-Eyberg Student Behavior Inventory (SESBI)
A rating scale for teachers measuring child externalizing behaviors. The two subscales Intensity (range 38-266) representing frequency, severity, or level of problem behaviors occurring from never (1) to always (7) and Problem (range 0-38) reflecting behaviors that are perceived as problems or not are reported independently. Higher values indicate more externalizing behaviors or more problems.
Measured: Change measures: baseline (pre) and after 6 months (post).
Eyberg Child Behavior Inventory (ECBI)
A rating scale for parents measuring child externalizing behaviors. The two subscales Intensity (range 36-252) representing frequency, severity, or level of problem behaviors occurring from never (1) to always (7) and Problem (range 0-36) reflecting behaviors that are perceived as problems or not are reported independently. Higher values indicate more externalizing behaviors or more problems.
Measured: Change measures: baseline (pre) and after 6 months (post).
Social Competence Scale (SCS)
A rating scale for teachers and parents estimating child prosocial behavior, communicative skills, and self-control containing two 5-point subscales with six items each; Prosocial (e.g., solve conflicts, share, helpful, listen, not bossy) and Emotional regulation (e.g., can accept a failure, calm down, think before acting, control temper). The total score may vary between 12 and 60. Higher values indicate better social competence.
Measured: Change measures: baseline (pre) and after 6 months (post).
Secondary outcomes (1)
Strengths and Difficulties Questionnaire (SDQ) Supplement - Impact and Burden
A rating scale for teachers and parents asking about child difficulties with emotions, concentration, behavior, and getting on with other people on a 4-point scale from no difficulties to severe difficulties. Consecutive items (three for teachers and five for parents) ask about child distress and social impairment in the domains of home life, friendships, classroom learning, and leisure activities. Total range for teachers was 0-12 (first question included) and total range for parents was 0-15 (first question excluded). Last, a burden item asks if the difficulties put a burden on the family or the preschool from not at all to much (range 0-3). Impact and Burden are reported separately. Higher values indicate more negative impact and burden because of behavior problems.
Measured: Change measures: baseline (pre) and after 6 months (post).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start18 Aug 2008
- Primary completion3 Feb 2011
- Study completion3 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit and Disruptive Behavior DisordersStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Model description
- Preschools randomized to either behavioral teacher training or as waiting list control preschools.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Social Services Administration, Ministry of Health and Social Affairs, Sweden
- Responsible party
- Sponsor
- Investigators
- Åsa K Kling, PhD student, Principal investigator, Uppsala UniversityMats Fredrikson, Professor, Study chair, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967509
- Sponsor's protocol ID
- SSA: DNR 3.2-0665/2009
- Other IDs
- 00-86/2009-36
- Acronym
- BPTT
- Status last verified
- Jun 2019
- First submitted
- 24 May 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Publications
Eyberg, S., Pincus, D. Eyberg Child behavior Inventory (ECBI) and Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R). Professional manual. Odessa, Florida: PAR, 1999.
Conduct Problems Prevention Research Group. Social Competence Scale (Parent), 1995. Retrieved from the Fast Track Project: http://www.fasttrackproject.org
Kling A, Forster M, Sundell K, Melin L. A randomized controlled effectiveness trial of parent management training with varying degrees of therapist support. Behav Ther. 2010 Dec;41(4):530-42. doi: 10.1016/j.beth.2010.02.004. Epub 2010 Oct 1.
PubMed 21035616Enebrink P, Hogstrom J, Forster M, Ghaderi A. Internet-based parent management training: a randomized controlled study. Behav Res Ther. 2012 Apr;50(4):240-9. doi: 10.1016/j.brat.2012.01.006. Epub 2012 Jan 30.
PubMed 22398153Forster, M., Sundell, K., Morris, R, Karlberg, M., Melin, L. A randomized controlled trial of a standardized behavior management intervention for students with externalizing behavior. Journal of Emotional and Behavioral Disorders, 20(3): 169-183, 2012
Forster, M., Kling, Å., Sundell, K. Clinical significance of parent training for children with conduct problems. International Journal of Conflict and Violence, 6(2): 187-200, 2012.
Ghaderi A, Kadesjo C, Bjornsdotter A, Enebrink P. Randomized effectiveness Trial of the Family Check-Up versus Internet-delivered Parent Training (iComet) for Families of Children with Conduct Problems. Sci Rep. 2018 Jul 31;8(1):11486. doi: 10.1038/s41598-018-29550-z.
PubMed 30065246Hogstrom J, Olofsson V, Ozdemir M, Enebrink P, Stattin H. Two-Year Findings from a National Effectiveness Trial: Effectiveness of Behavioral and Non-Behavioral Parenting Programs. J Abnorm Child Psychol. 2017 Apr;45(3):527-542. doi: 10.1007/s10802-016-0178-0.
PubMed 27334706Stattin H, Enebrink P, Ozdemir M, Giannotta F. A national evaluation of parenting programs in Sweden: The short-term effects using an RCT effectiveness design. J Consult Clin Psychol. 2015 Dec;83(6):1069-1084. doi: 10.1037/a0039328. Epub 2015 May 25.
PubMed 26009784Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
PubMed 9255702Goodman R. The extended version of the Strengths and Difficulties Questionnaire as a guide to child psychiatric caseness and consequent burden. J Child Psychol Psychiatry. 1999 Jul;40(5):791-9.
PubMed 10433412Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.
PubMed 11699809Malmberg M, Rydell AM, Smedje H. Validity of the Swedish version of the Strengths and Difficulties Questionnaire (SDQ-Swe). Nord J Psychiatry. 2003;57(5):357-63. doi: 10.1080/08039480310002697.
PubMed 14522609Axberg U, Johansson Hanse J, Broberg AG. Parents' description of conduct problems in their children - a test of the Eyberg Child Behavior Inventory (ECBI) in a Swedish sample aged 3-10. Scand J Psychol. 2008 Dec;49(6):497-505. doi: 10.1111/j.1467-9450.2008.00670.x. Epub 2008 Aug 12.
PubMed 18705675Conduct Problems Prevention Research Group. Social Competence Scale (Parent) - Technical reports, 1995-2002. Retrieved from: http://www.fasttrackproject.org
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Cluster Randomized Comet-program Behavioral Preschool Teacher Training in Reducing Externalizing Behavior
- ClinicalTrials.gov ID
- NCT03967509
- Acronym / sponsor ID
- BPTT / SSA: DNR 3.2-0665/2009
- Conditions
- Attention Deficit and Disruptive Behavior Disorders, Problem Behavior, Attention Deficit Disorder With Hyperactivity
- Keywords
- Externalizing behavior problems, Social competence, School readiness, Teacher management training, Cluster randomized effectiveness trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Social Services Administration, Ministry of Health and Social Affairs, Sweden
- Study start
- 18 Aug 2008 (actual)
- Primary completion
- 3 Feb 2011 (actual)
- Study completion
- 3 Feb 2011 (actual)
- First posted
- 30 May 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.
A cluster randomized controlled pre-post effectiveness trial of behavioral preschool teacher training (BPTT) delivered in a practitioner assisted group format for children with externalizing behavior problems. Preschools were randomized to either intervention in 25 preschools or as 22 waiting list control preschools, where teachers in preschool classes with the target child or children were program receivers. Participants were 100 target children 3-5 years old together with 72 enrolled preschool teachers and 83 parents as informants of behavioral outcomes after a five months period of implementation (at six months). The intervention was part of the Swedish evidence-based parent and teacher training programs (Comet) for children and youth with elevated externalizing behavior, and here an adapted version was tried in preschool for the first time. Also investigated was eventual generalized effects to the children's homes and improved social competence as an intermediate mechanism for reduced problem behavior. Effects of implementation fidelity in addition to social acceptability and relevance, such as reliable change, was investigated as well.
Detailed description
Study:
A cluster randomized controlled pre-post effectiveness trial of behavioral preschool teacher training (BPTT) delivered in a practitioner assisted group format for children with externalizing behavior problems. Preschools were randomized to either intervention in 25 preschools or to 22 waiting list control preschools, where preschool classes with the target child or children were program receivers. Informed preschools could apply for participation in the study, then, target children were screened for eligibility. Participants were 100 target children 3-5 years old together with 72 enrolled preschool teachers and 83 parents as informants of behavioral outcomes after a five months period of implementation (at six months).
Intervention:
The intervention was part of the Swedish evidence-based parent and teacher training programs (COmmunication METhod - Comet) for children and youths aged 3-12 and 12-18 years with moderate or elevated externalizing behavior, usually delivered in practitioner assisted group formats but previously evaluated as delivered via internet, single workshops followed by self-administered training, and universal prevention as well. Program implementations and evaluations are executed as collaboration projects between university researchers and the social services administration at place. Intervention content is influenced by operant conditioning, social learning theories, applied behavior analysis, and coercion theory. The focus is to establish a positive and effective interaction and communication style primarily through different reinforcement techniques (e.g., selective attention, more to positive behaviors and less to negative behaviors) and modeling. Parents or teachers meet in psychoeducational group sessions (often 9 to 11 sessions à 2.5 to 3 hours) led by one or two practitioner supervisors. They each follow a comprehensive manual and a highly structured curriculum. Training occurs at sessions (role-plays) and between sessions together with the children, followed-up with feedback in the next session.
Here an adapted version was tried in the preschool setting for the first time. The program corresponded in much to the parent training supplemented with techniques from the school teacher training and a group level administrated glove-puppet play technique to foster children's prosocial skills. (Results from the universal part of the program are not reported.) The nine sessions curriculum consisted of 2.5-hour biweekly meetings and two optional visits from supervisors with coaching on the spot. Practitioner supervisors (n = 27) were educated by a cognitive-behavior oriented psychologist during five days term one and two days term two.
Investigation issues:
The primary aim was to investigate behavioral outcome effects of the preschool teacher program. Would effects (Cohen's d) be in the medium-large range as found for Comet parent training (i.e., d = .50-.90) or in the small-medium range as often found for preventive developmental preschool programs (i.e., d = .20-.40)? With effects of about .40, a sample size restricted to 100 subjects, and an alpha at .05, power would be close to sufficient (i.e., .70). Of interest was to compare the effects of this program with effects found for other preschool program investigations of externalizing behavior problems.
Also investigated was eventual generalized effects to the children's homes. Of what magnitude would such effects be, if any, and would the parents' ratings validate the teachers' ratings, and thus, support the intervention? Such effects may have implications for future implementations, for example if the program is sufficiently efficient as a stand-alone intervention in reducing externalizing behavior problems or not sufficiently efficient. There was also a question of degree of informants agreement/discrepancy. Furthermore, would improved prosocial and regulatory skills function as a predictive and an intermediate mechanism for reduced problem behavior, and/or would there be room for other intervention features to contribute as well? In addition, as a trial in the real world, effects of implementation fidelity as well as social acceptability and relevance, such as proportions of children with reliable change, were investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Preschools randomized to either behavioral teacher training or as waiting list control preschools.
| Arm | Type | Receives |
|---|---|---|
| Behavioral teacher training | Experimental | Behavioral: CometBehavioral preschool teacher training (BPTT) delivered in an educational group format during nine 2,5-hour biweekly sessions with training at sessions and in between followed by supervisor's feedback on the practice and two optional coaching occasions on the spot. |
| Waiting list control group | No intervention | –Preschool teachers worked with children as usual. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Elevated level of externalizing behavior
- Exceeding cutoff value 11 on the Strengths and Difficulties Questionnaire, total scale
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| CometAlso: Comet in group format | Behavioural | Behavioral teacher training |
Primary outcome
Sutter-Eyberg Student Behavior Inventory (SESBI)
Time frame: Change measures: baseline (pre) and after 6 months (post).
A rating scale for teachers measuring child externalizing behaviors. The two subscales Intensity (range 38-266) representing frequency, severity, or level of problem behaviors occurring from never (1) to always (7) and Problem (range 0-38) reflecting behaviors that are perceived as problems or not are reported independently. Higher values indicate more externalizing behaviors or more problems.
Eyberg Child Behavior Inventory (ECBI)
Time frame: Change measures: baseline (pre) and after 6 months (post).
A rating scale for parents measuring child externalizing behaviors. The two subscales Intensity (range 36-252) representing frequency, severity, or level of problem behaviors occurring from never (1) to always (7) and Problem (range 0-36) reflecting behaviors that are perceived as problems or not are reported independently. Higher values indicate more externalizing behaviors or more problems.
Social Competence Scale (SCS)
Time frame: Change measures: baseline (pre) and after 6 months (post).
A rating scale for teachers and parents estimating child prosocial behavior, communicative skills, and self-control containing two 5-point subscales with six items each; Prosocial (e.g., solve conflicts, share, helpful, listen, not bossy) and Emotional regulation (e.g., can accept a failure, calm down, think before acting, control temper). The total score may vary between 12 and 60. Higher values indicate better social competence.
1 secondary outcome
Strengths and Difficulties Questionnaire (SDQ) Supplement - Impact and Burden
Time frame: Change measures: baseline (pre) and after 6 months (post).
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 Jun 2019.
- BackgroundEyberg, S., Pincus, D. Eyberg Child behavior Inventory (ECBI) and Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R). Professional manual. Odessa, Florida: PAR, 1999.
- BackgroundConduct Problems Prevention Research Group. Social Competence Scale (Parent), 1995. Retrieved from the Fast Track Project: http://www.fasttrackproject.org
- Results publication: PubMed 21035616Kling A, Forster M, Sundell K, Melin L. A randomized controlled effectiveness trial of parent management training with varying degrees of therapist support. Behav Ther. 2010 Dec;41(4):530-42. doi: 10.1016/j.beth.2010.02.004. Epub 2010 Oct 1.
- Results publication: PubMed 22398153Enebrink P, Hogstrom J, Forster M, Ghaderi A. Internet-based parent management training: a randomized controlled study. Behav Res Ther. 2012 Apr;50(4):240-9. doi: 10.1016/j.brat.2012.01.006. Epub 2012 Jan 30.
- Results publicationForster, M., Sundell, K., Morris, R, Karlberg, M., Melin, L. A randomized controlled trial of a standardized behavior management intervention for students with externalizing behavior. Journal of Emotional and Behavioral Disorders, 20(3): 169-183, 2012
- Results publicationForster, M., Kling, Å., Sundell, K. Clinical significance of parent training for children with conduct problems. International Journal of Conflict and Violence, 6(2): 187-200, 2012.
- Results publication: PubMed 30065246Ghaderi A, Kadesjo C, Bjornsdotter A, Enebrink P. Randomized effectiveness Trial of the Family Check-Up versus Internet-delivered Parent Training (iComet) for Families of Children with Conduct Problems. Sci Rep. 2018 Jul 31;8(1):11486. doi: 10.1038/s41598-018-29550-z.
- Results publication: PubMed 27334706Hogstrom J, Olofsson V, Ozdemir M, Enebrink P, Stattin H. Two-Year Findings from a National Effectiveness Trial: Effectiveness of Behavioral and Non-Behavioral Parenting Programs. J Abnorm Child Psychol. 2017 Apr;45(3):527-542. doi: 10.1007/s10802-016-0178-0.
- Results publication: PubMed 26009784Stattin H, Enebrink P, Ozdemir M, Giannotta F. A national evaluation of parenting programs in Sweden: The short-term effects using an RCT effectiveness design. J Consult Clin Psychol. 2015 Dec;83(6):1069-1084. doi: 10.1037/a0039328. Epub 2015 May 25.
- Results publication: PubMed 9255702Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
- Results publication: PubMed 10433412Goodman R. The extended version of the Strengths and Difficulties Questionnaire as a guide to child psychiatric caseness and consequent burden. J Child Psychol Psychiatry. 1999 Jul;40(5):791-9.
- Results publication: PubMed 11699809Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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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.
Åsa K Kling, PhD student principal investigator
Uppsala University
Mats Fredrikson, Professor study chair
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comet in people with Attention Deficit and Disruptive Behavior Disorders and Problem Behavior, run by Uppsala University 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 2 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: finished, as of the sponsor's last update on 20 Jun 2019. 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?
Sutter-Eyberg Student Behavior Inventory (SESBI) (time frame: Change measures: baseline (pre) and after 6 months (post).). The study lists 3 primary outcomes in all. 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 NCT03967509, which also lists 15 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 Jun 2019.