Clinical trial NCT06902649: Step-by-Step: Evaluation of a Stepped Care Model
Official title: Step-by-Step: Evaluation of a Stepped Care Model for Anger, Defiant, or Aggressive Behavior in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2025-03-30
Enrollment: 210
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).
timeFrame: 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.
measure: Parent: Mean change from baseline in oppositional defiant disorder and conduct disorder criteria
timeFrame: 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.
measure: Child/youth: Mean change from baseline in child-ratings of anger on the Anger Expression Scale for children
timeFrame: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program)
Secondary outcomes:
measure: Parent: Mean change from baseline in parent-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 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.
measure: Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale
timeFrame: 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.
measure: Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Scale (over-reactivity subscale)
timeFrame: 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.
measure: Parent: Mean change in parent-ratings of family warmth
timeFrame: 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.
measure: Parent: Mean change in parent-ratings of family conflicts
timeFrame: 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.
measure: Parent: Mean change from baseline in parent-ratings of parental emotion regulation on the Parent Emotion Regulation Scale
timeFrame: 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.
measure: Parent: Mean change from baseline in parent-ratings of child callous-unemotional traits on the Inventory of Callous-unemotional traits
timeFrame: 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.
measure: Parent: Mean change from baseline in parent-rated child life quality on the Child Health Utility 9 Dimensions
timeFrame: 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.
measure: Parent: Mean change from baseline in parental well-being on the Depression Anxiety and Stress Scale-21 (DASS21)
timeFrame: 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.
measure: Child/youth: Mean change from baseline in child-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program)
measure: Child/youth: Mean change from baseline in child-ratings of child life quality on the Child Health Utility 9 Dimensions
timeFrame: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program)
measure: Parent: Mean change in ratings of satisfaction with the week
timeFrame: Weeks 0 to 15 after baseline. Completed once a week at each session.
measure: Child: Mean change in ratings of satisfaction with the week
timeFrame: Weeks 6 to 15 after baseline. Completed once a week at each session.
measure: Parental and child experiences of each session
timeFrame: Weeks 6 to 15 after baseline. Completed once a week at each session
measure: Parent: Inventory of health-related costs
timeFrame: Pre- and post-intervention (15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
Other outcomes:
measure: Parent: Background information
timeFrame: Pre-intervention
measure: Parent: Background information about number of limited prosocial emotions (callous-unemotional traits)
timeFrame: Pre-intervention
measure: Parent: Number of participants with oppositional defiant disorder or conduct disorder diagnosis
timeFrame: Pre-intervention
measure: Use of each intervention: number of sessions, homework tasks
timeFrame: From pre- to post-interventions (between 6 to 15 weeks after the initiation of the intervention)
measure: Drop-out rate
timeFrame: From pre- to post-intervention (6 to 15 weeks after the initiation of the intervention)
measure: Experiences of the interventions through individual qualitative interviews with parent and youth
timeFrame: After the interventions are completed, about 15-20 weeks after the initiation of the first intervention
measure: Parent and child: Closing questions about the intervention
timeFrame: Post-intervention (measured between 6 to 10 weeks after the initiation of the intervention)]
measure: Parent: Closing question about possible negative effects of the interventions
timeFrame: Post-intervention (measured 15 weeks after the initiation of the internet-based intervention)
measure: Parent: Information about participation in interventions
timeFrame: Post-intervention (measured 15 weeks after the initiation of the internet-based intervention)
measure: Clinician: perception of implementation
timeFrame: Weeks 6 to 15 after baseline. Completed once a week at each session.
Locations:
city: Solna
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Pia Enebrink, PhD
role: PRINCIPAL_INVESTIGATOR
References: