Child Behavior ProblemNCT06902649
Step-by-Step: Evaluation of a Stepped Care Model
A study testing Internet-based parenting support, "YourSkills" for children/youth and Step-by-step parent support in people with Child Behavior Problem and Disruptive Behavior, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The primary aim of this project is to examine the effectiveness of a stepped care model of interventions for children's defiant or aggressive behavior problems. The stepped model consists of a brief internet-based parenting support program (Step 1). Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Child Behavior Problem, Disruptive Behavior, Oppositional Defiant Disorder
- What is being tested?
- Internet-based parenting support, "YourSkills" for children/youth and Step-by-step parent support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSweden
- Study dates
- 2 Apr 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Families with children aged 8-16 years who have difficulty controlling anger or exhibit defiant or aggressive behavior. The child/adolescent meets 3 of the diagnostic criteria for Oppositional Defiant Disorder or 2 criteria for Conduct Disorder indicating aggressive behavior.
- Medication for the child can remain stable.
- Parents need to be able to read and engage with materials in Swedish
Who cannot join
- Families with children younger than 8 years old or who have already turned 17, or who do not exhibit defiant or aggressive behaviors according to the first inclusion criterion.
- Children with severe depression, suicidal behavior, bipolar disorder, psychosis, eating disorders, severe autism (level 2 and 3), diagnosed intellectual disability, or ongoing criminal behavior assessed to require interventions other than the study's interventions are excluded.
- Children/adolescents with other ongoing psychological treatments for the same condition or assessed by the clinician in need of other interventions
- Parents and children with epilepsy or migraines
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Step-by-Step: Evaluation of a Stepped Care Model for Anger, Defiant, or Aggressive Behavior in Children and Adolescents
The primary aim of this project is to examine the effectiveness of a stepped care model of interventions for children's defiant or aggressive behavior problems. The stepped model consists of a brief internet-based parenting support program (Step 1). For those with continued need of additional interventions, Step 2 includes access to one of following interventions: b) a Cognitive Behavior Therapy (CBT) -Virtual Reality (VR)-assisted parenting support program, b) a Cognitive Behavior Therapy -Virtual Reality-assisted child intervention, or c) standard interventions/support at the family's unit/clinic and continued access to the study's internet-based parenting support program, after which the family may choose CBT-VR for the child or the parent.
Read the detailed description
Children who exhibit severe aggressive and defiant behavior from an early age are at increased risk of persistent behavioral problems during adolescence and into young adulthood. Additionally, they are more likely to experience difficulties in social contexts, lack prosocial friendships, fall behind academically in school, and have poorer mental well-being.
Parenting support programs are recommended for parents of children under the age of 12 with oppositional defiant disorder or conduct disorder, as well as for parents of adolescents with less severe behavioral problems. Therefore, such programs can serve as a foundation for interventions offered to parents of children with behavioral problems. However, many parenting support programs are delivered in a group format, are not possible to attend for all parents, have challenges related to parental engagement and dropout, and fewer programs have been evaluated for parents of adolescents.
Cognitive behavioral therapy (CBT) for children with behavioral problems, including anger management training, social skills training, and problem-solving training, have been shown to reduce anger and aggressive behavior and may complement parent support programs for children/youth with behavior problems.
However, there still remains a need for effective stepped care interventions for parents and children/youth with behavior problems.
PURPOSE AND RESEARCH QUESTIONS:
The main aim is to examine the effectiveness of a stepped care model of interventions for families with children/youth aged 8-16 years with behavioral problems, consisting of (Step 1) a brief internet-based parenting support program, and thereafter access to one of following interventions: a) a Cognitive Behavior Therapy (CBT)-Virtual Reality (VR)-assisted parenting support program, b) a CBT-VR-assisted child intervention, or c) standard interventions/support at the family's unit/clinic and continued access to the study's internet-based parenting support program (Step 2). The specific research questions are as follows:
- What is the effect of the internet-based parenting support program (Step 1), the CBT-VR parenting support program, and the CBT-VR child intervention over time and compared to standard interventions/support (Step 2), on children's behavioral problems, emotional and overall well-being, parental emotion regulation, wellbeing, parenting strategies and family conflicts-both immediately after the interventions and six months after Step 2? How are the interventions perceived by parents and children?
- To what extent do (a) improved emotion regulation, (b) increased warmth in the family, and (c) a reduction in negative parenting styles contribute to a decrease in children's behavioral problems, i.e., do these variables mediate the outcomes?
- To what extent do (a) the severity of children's behavioral problems, including diagnoses such as attention deficit hyperactivity disorder, oppositional defiant disorder, and conduct disorder, (b) limited prosocial emotions (so-called callous-unemotional traits), (c) the child's age, gender and (d) parents' initial level of positive parenting style contribute to understanding which families benefit more or less from the interventions, i.e., do these variables moderate or predict the outcomes?
- To what extent is the stepped care model cost-effective?
METHODS:
This is a project evaluating a two-step intervention care model. The evaluation of each intervention is conducted using a within-group design (repeated measurements before, during, and after each intervention) and, in Step 2, also includes between-group comparisons. Participants are recruited through clinics/units where the interventions are conducted.
Brief written information about the study is available on websites and information channels of the participating units. Families with children of the appropriate age, 8-16 years, and behavioral problems, are informed about the study. After the family/caregivers have reviewed detailed written information and consented to the study (written informed consent), the family is contacted by a clinician/research assistant for a screening interview of inclusion and exclusion criteria. All included parents receive Step 1, the internet-based parent-support. After Step 1, families who wish to continue are randomized to receive either CBT-VR for parents, CBT-VR for children, or standard interventions/support at the family's unit/clinic and continued access to the internet-based parenting support program, whereafter they get access to CBT-VR for children or parents if they want to.
The treatment is evaluated quantitatively by parents and children, using validated assessment scales before, during and after each treatment. Additionally, interviews are conducted with a number of parents and children who have agreed to participate.
POWER CALCULATION:
To identify a moderate treatment effect in Step 2 of the child or parent CBT-VR intervention compared to standard interventions/support (p < .05, power = .80), accounting for a 20% dropout rate, 70 families are needed in the CBT-VR parent, CBT-VR child, and standard intervention groups, i.e., 210 families. Assuming that 33-50% of parents will be in need of the second step, a total of 500-750 parents should be included in the first step, pending a drop-out rate of 20%. Data collection will be completed once 210 families have been included in Step 2.
ANALYSES:
Quantitative data will be visually inspected through graphs, mean values of data, slopes, and variation over time. Differences over time and between groups will be analyzed statistically for both Step 1 and 2-interventions, using methods such as nonparametric tests, General Linear Mixed Modeling (GLMM), paired t-tests, Analysis of variance (ANOVA), Mixed models, Linear regression models. Cohen's d and Reliable Clinical Change will be calculated for all interventions to understand the clinical implications of the results. The primary outcome measure will be compared with results from other parenting support studies, i.e., benchmarking.
Moderator analyses will be conducted through ANOVAs, Linear regression models. Mediation analyses will be conducted using the SPSS (Statistical Package for the Social Sciences) add-on PROCESS macro and bootstrapping, and Linear mixed models.
Qualitative interview-data will be analyzed with thematic analysis.
The health economic evaluation will include two analyses: 1) cost-effectiveness analysis and 2) cost-utility analysis with the outcome measure quality-adjusted life years (QALYs).
- Conditions
- Child Behavior Problem, Disruptive Behavior, Oppositional Defiant Disorder, Conduct Problems, Aggression, Anger
- Being tested
- Internet-based parenting support, "YourSkills" for children/youth, Step-by-step parent support, Intervention/support as usual and prolonged use of internet-based parenting support
- Keywords
- Disruptive Behavior, Child Behavior Problem, Cognitive behavior therapy, Virtual Reality, Parenting support program
- Medical subject headings
- Problem Behavior, Oppositional Defiant Disorder, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based parenting supportBehavioural
An internet-based parent training program with 5 active modules and a final summarizing module, based on social learning theory/cognitive behavior therapy. All parents participate in this intervention (Step 1) before being randomized to the other three arms of the stepped care model in the randomized controlled trial (Step 2).
"YourSkills" for children/youthBehavioural
Cognitive behavioral therapy for children/youth with role-plays in virtual reality. A program for children/youth with anger problems or aggressive behaviors based on social learning theory and cognitive behavior therapy (CBT), incorporating virtual reality (VR) when conducting brief role-plays. The program includes similar strategies as other CBT-oriented programs for anger problems, with the addition of VR for practicing skills.
Step-by-step parent supportBehavioural
A parent training program based on social learning theory and cognitive behavioral therapy (CBT), including some sessions where virtual reality may be used for training in brief role plays. The program includes similar strategies as other common CBT-parent training programs for parents of children with behavior problems, with the difference that virtual reality can be used as an additional way to practice skills.
Intervention/support as usual and prolonged use of internet-based parenting supportBehavioural
Based on other available support, interventions, courses at the units. Parents have access to the internet-based parenting support provided in Step 1 (the first intervention of the study). After 10 weeks with intervention/support as usual, the parents are asked if they want to participate in the CBT-VR-intervention for children (YourSkills) or for parents (Step-by-Step parent support).
| Study group | Role | What they receive |
|---|---|---|
| Internet-based parenting support | Experimental | 5 weeks of internet-based parenting support provided as a first step for all parents (Step 1 in the stepped care model). Receives: Behavioral: Internet-based parenting support |
| "YourSkills" for children/youth | Experimental | A cognitive-behavioral program for children and youth with up to 10 individual, face-to-face, weekly sessions, where role-plays can be conducted in virtual reality. (Step 2 in the stepped care model) Receives: Behavioral: "YourSkills" for children/youth |
| Step-by-step parent support | Experimental | A parent training program with between 6 and 10 individual, face-to-face, weekly sessions with parents. Role-plays may be conducted in virtual reality. (Step 2 in the stepped care model) Receives: Behavioral: Step-by-step parent support |
| Intervention/supports as usual and prolonged use of internet-based parenting support | Active comparator | Based on other available support at the units and prolonged use of internet-based parenting support program. (Step 2 in the stepped-care model) Receives: Behavioral: Intervention/support as usual and prolonged use of internet-based parenting support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).
The oppositional defiant disorder subscale of the Disruptive Behavior Disorder scale is used for assessing children's behavioral problems. The subscale includes 8 items which are rated on a 4-point scale (0 to 3). The total scale sum ranges from 0 to a total maximum sum of 24 with a higher score indicating more behavior problems.
Measured: Pre-, mid- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change from baseline in oppositional defiant disorder and conduct disorder criteria
The number of Oppositional defiant disorder criteria (between 0-8) and Conduct disorder criteria (aggressive symptoms; between 0-5). Total number ranges between 0-13 criteria.
Measured: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Child/youth: Mean change from baseline in child-ratings of anger on the Anger Expression Scale for children
The Anger expression scale for children includes 26 questions about anger and anger management and is rated by children on a 4-point Likert scale (from 1 to 4). Two modified sub-scales are used: anger expression (score ranges from 17 to 68) and anger control (score ranges from 9 to 36) with higher scores indicating higher levels of anger expression and anger control.
Measured: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program)
Secondary outcomes (15)
Parent: Mean change from baseline in parent-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)
The Strengths and Difficulties Questionnaire (SDQ) is used to assess mental health through a total difficulties score as well as through the five subscales (peer relationship problems, prosocial behavior, emotional symptoms, hyperactivity/inattention, conduct problems). The items are scored on a 3-point scale (0 to 2), and the total difficulties score is generated by summing all subscales except the prosocial scale. The summary score ranges from 0 to 40. Higher summary scores indicate more problems.
Measured: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale
The Parenting Children and Adolescent Scale has three subscales: encouragement of positive behaviors, setting limits, proactive parenting behaviors, each including 7 items. The 21 items are scored on a 5-point scale (1 to 5) and the total scale sum ranges from 21 to a maximum of 105, with a higher score indicating more positive parenting. The proactive parenting behavior-subscale at baseline is used for moderator/predictor analyses.
Measured: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Scale (over-reactivity subscale)
The Parenting Scale has one subscale that measures parental over-reactivity. The 5 items are scored on a 7-point scale (1 to 7) and the total scale sum ranges from 7 to a maximum of 35. A lower score indicates more positive parenting (after reverse coding). The Parenting Scale is included as a mediator of outcome.
Measured: Pre-, mid-, and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change in parent-ratings of family warmth
Family warmth is measured with 5 questions from the Family Check-Up Caregiver Assessment Scale. These are scored on a 5-point scale (1 to 5). Total maximum score ranges between 5 and 25. A higher score indicates a more positive relation. Warmth is included as a mediator of outcome.
Measured: Pre-, mid-, and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change in parent-ratings of family conflicts
Family conflicts are measured with 3 questions from the Family Check-Up Caregiver Assessment Scale. These are scored on a 7-point scale (0 to 6). Total maximum score ranges between 0 and 18. A higher score indicates larger degree of conflicts.
Measured: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change from baseline in parent-ratings of parental emotion regulation on the Parent Emotion Regulation Scale
Emotion regulation of the parent will be measured with the Parent Emotion Regulation Scale. The 20 items are scored on a 5-point scale (1 to 5) and are divided into four subscales: Orientation to child's emotions (5 items); Acceptance of child's and parents' emotions (4 items); Avoidance of child's emotions (6 items), Emotional lack of control (5 items). The total summary score ranges between 20 and 100 where a higher total score indicates better regulation of emotions. The subscale Emotional lack of control is included as a mediator of outcome.
Measured: Pre-, mid-, and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change from baseline in parent-ratings of child callous-unemotional traits on the Inventory of Callous-unemotional traits
Child callous-unemotional traits will be measured with the Inventory of Callous-unemotional traits. The 24 items are scored on a 4-point scale (0 to 3). Total sum ranges between 0-72, with higher scores indicating a greater degree of general callous-unemotional traits. The ICU has three subscales: callousness (11 items), uncaring (8 items), and unemotional (5 items).
Measured: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change from baseline in parent-rated child life quality on the Child Health Utility 9 Dimensions
Child life quality will be measured with the Child Health Utility 9 Dimensions (CHU9D).The 9 items are scored on a 5-point scale (1 to 5). Total sum ranges between 9-45, with higher scores indicating a greater degree life quality.
Measured: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change from baseline in parental well-being on the Depression Anxiety and Stress Scale-21 (DASS21)
Parents indicate their emotional negative state on the Depression Anxiety and Stress scale-21, which consists of 21 items that are rated on a 4-point scale (0 to 3). A higher total score indicates greater overall distress, with a maximum score of 63. The scale includes three subscales: Depression (0-21), Anxiety (0-21) and Stress (0-21). Scores are doubled to allow for comparison with the 42-item DASS-scale.
Measured: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Child/youth: Mean change from baseline in child-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)
Child-ratings of Strengths and Difficulties Questionnaire are used to assess mental health through a total difficulties score as well as through the five subscales (peer relationship problems, prosocial behavior, emotional symptoms, hyperactivity/inattention, conduct problems). The items are scored on a 3-point scale (0 to 2), and the total difficulties score is generated by summing all subscales except the prosocial scale. The summary score ranges from 0 to 40 where higher summary scores indicate more severe problems.
Measured: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program)
Child/youth: Mean change from baseline in child-ratings of child life quality on the Child Health Utility 9 Dimensions
Child life quality will be measured with the Child Health Utility 9 Dimensions (CHU9D).The 9 items are scored on a 5-point scale (1 to 5). Total sum ranges between 9-45, with higher scores indicating a greater degree life quality.
Measured: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program)
Parent: Mean change in ratings of satisfaction with the week
Three questions to parents scored 0 to 10 for those participating in an intervention, about their satisfaction with the week and with managing situations. Total maximum score ranges between 0-30, with a higher score indicating higher satisfaction.
Measured: Weeks 0 to 15 after baseline. Completed once a week at each session.
Child: Mean change in ratings of satisfaction with the week
Three questions to children scored 0 to 10 for children participating in an intervention, about their satisfaction with the week and with how managing situations or emotions. Total maximum score ranges between 0-30, with a higher score indicating higher satisfaction.
Measured: Weeks 6 to 15 after baseline. Completed once a week at each session.
Parental and child experiences of each session
Four questions after each session about how the parent or child experienced the session and exercises. Rated on a scale 0-10, with a maximum total score ranging between 0 and 40. A higher score indicates greater satisfaction with the session.
Measured: Weeks 6 to 15 after baseline. Completed once a week at each session
Parent: Inventory of health-related costs
Treatment inventory of costs in patients with psychiatric disorders (Tic-P) collects information about medical costs and productivity losses, and includes questions about health care use, treatments, paid and unpaid labour. In this study it is used for parents of children with behavior problems. The scale is used for a health-economic evaluation of the stepped-care model and includes no summary scores.
Measured: Pre- and post-intervention (15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start2 Apr 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior ProblemStudies 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
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Pia Enebrink, Karolinska Institutet
- Investigators
- Pia Enebrink, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902649
- Sponsor's protocol ID
- 2025-00381-01
- Other IDs
- 2025
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2025
- Last updated
- 6 Mar 2026
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step-by-Step: Evaluation of a Stepped Care Model for Anger, Defiant, or Aggressive Behavior in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06902649
- Acronym / sponsor ID
- 2025-00381-01
- Conditions
- Child Behavior Problem, Disruptive Behavior, Oppositional Defiant Disorder, Conduct Problems, Aggression, Anger
- Keywords
- Disruptive Behavior, Child Behavior Problem, Cognitive behavior therapy, Virtual Reality, Parenting support program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 30 Mar 2025 (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.
The primary aim of this project is to examine the effectiveness of a stepped care model of interventions for children's defiant or aggressive behavior problems. The stepped model consists of a brief internet-based parenting support program (Step 1). For those with continued need of additional interventions, Step 2 includes access to one of following interventions: b) a Cognitive Behavior Therapy (CBT) -Virtual Reality (VR)-assisted parenting support program, b) a Cognitive Behavior Therapy -Virtual Reality-assisted child intervention, or c) standard interventions/support at the family's unit/clinic and continued access to the study's internet-based parenting support program, after which the family may choose CBT-VR for the child or the parent.
Detailed description
Children who exhibit severe aggressive and defiant behavior from an early age are at increased risk of persistent behavioral problems during adolescence and into young adulthood. Additionally, they are more likely to experience difficulties in social contexts, lack prosocial friendships, fall behind academically in school, and have poorer mental well-being.
Parenting support programs are recommended for parents of children under the age of 12 with oppositional defiant disorder or conduct disorder, as well as for parents of adolescents with less severe behavioral problems. Therefore, such programs can serve as a foundation for interventions offered to parents of children with behavioral problems. However, many parenting support programs are delivered in a group format, are not possible to attend for all parents, have challenges related to parental engagement and dropout, and fewer programs have been evaluated for parents of adolescents.
Cognitive behavioral therapy (CBT) for children with behavioral problems, including anger management training, social skills training, and problem-solving training, have been shown to reduce anger and aggressive behavior and may complement parent support programs for children/youth with behavior problems.
However, there still remains a need for effective stepped care interventions for parents and children/youth with behavior problems.
PURPOSE AND RESEARCH QUESTIONS:
The main aim is to examine the effectiveness of a stepped care model of interventions for families with children/youth aged 8-16 years with behavioral problems, consisting of (Step 1) a brief internet-based parenting support program, and thereafter access to one of following interventions: a) a Cognitive Behavior Therapy (CBT)-Virtual Reality (VR)-assisted parenting support program, b) a CBT-VR-assisted child intervention, or c) standard interventions/support at the family's unit/clinic and continued access to the study's internet-based parenting support program (Step 2). The specific research questions are as follows:
- What is the effect of the internet-based parenting support program (Step 1), the CBT-VR parenting support program, and the CBT-VR child intervention over time and compared to standard interventions/support (Step 2), on children's behavioral problems, emotional and overall well-being, parental emotion regulation, wellbeing, parenting strategies and family conflicts-both immediately after the interventions and six months after Step 2? How are the interventions perceived by parents and children?
- To what extent do (a) improved emotion regulation, (b) increased warmth in the family, and (c) a reduction in negative parenting styles contribute to a decrease in children's behavioral problems, i.e., do these variables mediate the outcomes?
- To what extent do (a) the severity of children's behavioral problems, including diagnoses such as attention deficit hyperactivity disorder, oppositional defiant disorder, and conduct disorder, (b) limited prosocial emotions (so-called callous-unemotional traits), (c) the child's age, gender and (d) parents' initial level of positive parenting style contribute to understanding which families benefit more or less from the interventions, i.e., do these variables moderate or predict the outcomes?
- To what extent is the stepped care model cost-effective?
METHODS:
This is a project evaluating a two-step intervention care model. The evaluation of each intervention is conducted using a within-group design (repeated measurements before, during, and after each intervention) and, in Step 2, also includes between-group comparisons. Participants are recruited through clinics/units where the interventions are conducted.
Brief written information about the study is available on websites and information channels of the participating units. Families with children of the appropriate age, 8-16 years, and behavioral problems, are informed about the study. After the family/caregivers have reviewed detailed written information and consented to the study (written informed consent), the family is contacted by a clinician/research assistant for a screening interview of inclusion and exclusion criteria. All included parents receive Step 1, the internet-based parent-support. After Step 1, families who wish to continue are randomized to receive either CBT-VR for parents, CBT-VR for children, or standard interventions/support at the family's unit/clinic and continued access to the internet-based parenting support program, whereafter they get access to CBT-VR for children or parents if they want to.
The treatment is evaluated quantitatively by parents and children, using validated assessment scales before, during and after each treatment. Additionally, interviews are conducted with a number of parents and children who have agreed to participate.
POWER CALCULATION:
To identify a moderate treatment effect in Step 2 of the child or parent CBT-VR intervention compared to standard interventions/support (p < .05, power = .80), accounting for a 20% dropout rate, 70 families are needed in the CBT-VR parent, CBT-VR child, and standard intervention groups, i.e., 210 families. Assuming that 33-50% of parents will be in need of the second step, a total of 500-750 parents should be included in the first step, pending a drop-out rate of 20%. Data collection will be completed once 210 families have been included in Step 2.
ANALYSES:
Quantitative data will be visually inspected through graphs, mean values of data, slopes, and variation over time. Differences over time and between groups will be analyzed statistically for both Step 1 and 2-interventions, using methods such as nonparametric tests, General Linear Mixed Modeling (GLMM), paired t-tests, Analysis of variance (ANOVA), Mixed models, Linear regression models. Cohen's d and Reliable Clinical Change will be calculated for all interventions to understand the clinical implications of the results. The primary outcome measure will be compared with results from other parenting support studies, i.e., benchmarking.
Moderator analyses will be conducted through ANOVAs, Linear regression models. Mediation analyses will be conducted using the SPSS (Statistical Package for the Social Sciences) add-on PROCESS macro and bootstrapping, and Linear mixed models.
Qualitative interview-data will be analyzed with thematic analysis.
The health economic evaluation will include two analyses: 1) cost-effectiveness analysis and 2) cost-utility analysis with the outcome measure quality-adjusted life years (QALYs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Internet-based parenting support | Experimental | Behavioral: Internet-based parenting support5 weeks of internet-based parenting support provided as a first step for all parents (Step 1 in the stepped care model). |
| "YourSkills" for children/youth | Experimental | Behavioral: "YourSkills" for children/youthA cognitive-behavioral program for children and youth with up to 10 individual, face-to-face, weekly sessions, where role-plays can be conducted in virtual reality. (Step 2 in the stepped care model) |
| Step-by-step parent support | Experimental | Behavioral: Step-by-step parent supportA parent training program with between 6 and 10 individual, face-to-face, weekly sessions with parents. Role-plays may be conducted in virtual reality. (Step 2 in the stepped care model) |
| Intervention/supports as usual and prolonged use of internet-based parenting support | Active comparator | Behavioral: Intervention/support as usual and prolonged use of internet-based parenting supportBased on other available support at the units and prolonged use of internet-based parenting support program. (Step 2 in the stepped-care model) |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Families with children aged 8-16 years who have difficulty controlling anger or exhibit defiant or aggressive behavior. The child/adolescent meets 3 of the diagnostic criteria for Oppositional Defiant Disorder or 2 criteria for Conduct Disorder indicating aggressive behavior.
- Medication for the child can remain stable.
- Parents need to be able to read and engage with materials in Swedish
Key exclusion criteria (4 listed)
- Families with children younger than 8 years old or who have already turned 17, or who do not exhibit defiant or aggressive behaviors according to the first inclusion criterion.
- Children with severe depression, suicidal behavior, bipolar disorder, psychosis, eating disorders, severe autism (level 2 and 3), diagnosed intellectual disability, or ongoing criminal behavior assessed to require interventions other than the study's interventions are excluded.
- Children/adolescents with other ongoing psychological treatments for the same condition or assessed by the clinician in need of other interventions
- Parents and children with epilepsy or migraines
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 |
|---|---|---|
| Internet-based parenting supportAn internet-based parent training program with 5 active modules and a final summarizing module, based on social learning theory/cognitive behavior therapy. All parents participate in this intervention (Step 1) before being randomized to the other three arms of the stepped care model in the randomized controlled trial (Step 2). | Behavioural | Internet-based parenting support |
| "YourSkills" for children/youthCognitive behavioral therapy for children/youth with role-plays in virtual reality. A program for children/youth with anger problems or aggressive behaviors based on social learning theory and cognitive behavior therapy (CBT), incorporating virtual reality (VR) when conducting brief role-plays. The program includes similar strategies as other CBT-oriented programs for anger problems, with the addition of VR for practicing skills. | Behavioural | "YourSkills" for children/youth |
| Step-by-step parent supportA parent training program based on social learning theory and cognitive behavioral therapy (CBT), including some sessions where virtual reality may be used for training in brief role plays. The program includes similar strategies as other common CBT-parent training programs for parents of children with behavior problems, with the difference that virtual reality can be used as an additional way to practice skills. | Behavioural | Step-by-step parent support |
| Intervention/support as usual and prolonged use of internet-based parenting supportBased on other available support, interventions, courses at the units. Parents have access to the internet-based parenting support provided in Step 1 (the first intervention of the study). After 10 weeks with intervention/support as usual, the parents are asked if they want to participate in the CBT-VR-intervention for children (YourSkills) or for parents (Step-by-Step parent support). | Behavioural | Intervention/supports as usual and prolonged use of internet-based parenting support |
Primary outcome
Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).
Time frame: Pre-, mid- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
The oppositional defiant disorder subscale of the Disruptive Behavior Disorder scale is used for assessing children's behavioral problems. The subscale includes 8 items which are rated on a 4-point scale (0 to 3). The total scale sum ranges from 0 to a total maximum sum of 24 with a higher score indicating more behavior problems.
Parent: Mean change from baseline in oppositional defiant disorder and conduct disorder criteria
Time frame: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
The number of Oppositional defiant disorder criteria (between 0-8) and Conduct disorder criteria (aggressive symptoms; between 0-5). Total number ranges between 0-13 criteria.
Child/youth: Mean change from baseline in child-ratings of anger on the Anger Expression Scale for children
Time frame: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program)
The Anger expression scale for children includes 26 questions about anger and anger management and is rated by children on a 4-point Likert scale (from 1 to 4). Two modified sub-scales are used: anger expression (score ranges from 17 to 68) and anger control (score ranges from 9 to 36) with higher scores indicating higher levels of anger expression and anger control.
15 secondary outcomes
Parent: Mean change from baseline in parent-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)
Time frame: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale
Time frame: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Scale (over-reactivity subscale)
Time frame: Pre-, mid-, and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change in parent-ratings of family warmth
Time frame: Pre-, mid-, and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change in parent-ratings of family conflicts
Time frame: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change from baseline in parent-ratings of parental emotion regulation on the Parent Emotion Regulation Scale
Time frame: Pre-, mid-, and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change from baseline in parent-ratings of child callous-unemotional traits on the Inventory of Callous-unemotional traits
Time frame: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change from baseline in parent-rated child life quality on the Child Health Utility 9 Dimensions
Time frame: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Parent: Mean change from baseline in parental well-being on the Depression Anxiety and Stress Scale-21 (DASS21)
Time frame: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Child/youth: Mean change from baseline in child-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)
Time frame: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program)
Child/youth: Mean change from baseline in child-ratings of child life quality on the Child Health Utility 9 Dimensions
Time frame: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program)
Parent: Mean change in ratings of satisfaction with the week
Time frame: Weeks 0 to 15 after baseline. Completed once a week at each session.
Child: Mean change in ratings of satisfaction with the week
Time frame: Weeks 6 to 15 after baseline. Completed once a week at each session.
Parental and child experiences of each session
Time frame: Weeks 6 to 15 after baseline. Completed once a week at each session
Parent: Inventory of health-related costs
Time frame: Pre- and post-intervention (15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- 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.
Pia Enebrink, PhD 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 Internet-based parenting support, "YourSkills" for children/youth and Step-by-step parent support in people with Child Behavior Problem and Disruptive Behavior, 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 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pia Enebrink, PhD (+46852487738, pia.enebrink@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale). (time frame: Pre-, mid- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.). 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?
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 6 Mar 2026.