Step-by-Step: Evaluation of a Stepped Care Model

Not Applicable

Not yet recruiting

• Conditions: Child Behavior Problem; Disruptive Behavior; Conduct Problems; Oppositional Defiant Disorder; Aggression; Anger

• Registration Number: NCT06902649
• Lead Sponsor: Karolinska Institutet

Brief 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). 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:

1. 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?

2. 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?

3. 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?

4. 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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study Start: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Parent: Mean change from baseline in oppositional defiant disorder and conduct disorder criteria	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.
Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).	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.
Child/youth: Mean change from baseline in child-ratings of anger on the Anger Expression Scale for children	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.

Secondary Outcome Measures

Name	Time	Method
Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Scale (over-reactivity subscale)	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 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.
Child/youth: Mean change from baseline in child-ratings of child life quality on the Child Health Utility 9 Dimensions	Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program)	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.
Parent: Mean change in ratings of satisfaction with the week	Weeks 0 to 15 after baseline. Completed once a week at each session.	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.
Child: Mean change in ratings of satisfaction with the week	Weeks 6 to 15 after baseline. Completed once a week at each session.	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.
Parental and child experiences of each session	Weeks 6 to 15 after baseline. Completed once a week at 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.
Parent: Mean change from baseline in parent-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)	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 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.
Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale	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 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.
Parent: Mean change in parent-ratings of family warmth	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.	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.
Parent: Mean change in parent-ratings of family conflicts	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.	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.
Parent: Mean change from baseline in parent-ratings of parental emotion regulation on the Parent Emotion Regulation Scale	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.	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.
Parent: Mean change from baseline in parent-ratings of child callous-unemotional traits on the Inventory of Callous-unemotional traits	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 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).
Parent: Mean change from baseline in parent-rated child life quality on the Child Health Utility 9 Dimensions	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 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.
Parent: Mean change from baseline in parental well-being on the Depression Anxiety and Stress Scale-21 (DASS21)	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.	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.
Child/youth: Mean change from baseline in child-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)	Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program)	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.
Parent: Inventory of health-related costs	Pre- and post-intervention (15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.	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.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Solna, Sweden