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

NCT ID: NCT06902649

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-27
• Study Completion Date: 2027-08-31

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-based parenting support

5 weeks of internet-based parenting support provided as a first step for all parents (Step 1 in the stepped care model).

Group Type: EXPERIMENTAL

Internet-based parenting support

Intervention Type: BEHAVIORAL

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/youth

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)

Group Type: EXPERIMENTAL

"YourSkills" for children/youth

Intervention Type: BEHAVIORAL

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 support

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)

Group Type: EXPERIMENTAL

Step-by-step parent support

Intervention Type: BEHAVIORAL

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/supports as usual and prolonged use of internet-based parenting support

Based on other available support at the units and prolonged use of internet-based parenting support program. (Step 2 in the stepped-care model)

Group Type: ACTIVE_COMPARATOR

Intervention/support as usual and prolonged use of internet-based parenting support

Intervention Type: BEHAVIORAL

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).

Interventions

Internet-based parenting support

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).

Intervention Type: BEHAVIORAL

"YourSkills" for children/youth

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.

Intervention Type: BEHAVIORAL

Step-by-step parent support

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 Type: BEHAVIORAL

Intervention/support as usual and prolonged use of internet-based parenting support

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Pia Enebrink

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pia Enebrink, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet

Solna, , Sweden

Countries

Sweden

Central Contacts

Pia Enebrink, PhD

Role: CONTACT

pia.enebrink@ki.se

+46852487738

Other Identifiers

2025-00381-01

Identifier Type: -

Identifier Source: org_study_id