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

NCT06902649 | Recruiting

• 1 other identifier: 2025-00381-01
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Disruptive Behavior; Child Behavior Problem; Cognitive behavior therapy; Virtual Reality; Parenting support program

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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)

  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

  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)

  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

  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

  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.

Other Outcomes (10)

• Parent: Background information

  Pre-intervention

• Parent: Background information about number of limited prosocial emotions (callous-unemotional traits)

  Pre-intervention

• Parent: Number of participants with oppositional defiant disorder or conduct disorder diagnosis

  Pre-intervention

Study Arms (4)

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).

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)

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)

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)

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

Interventions

Internet-based parenting support 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).

Internet-based parenting support

"YourSkills" for children/youth 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.

"YourSkills" for children/youth

Step-by-step parent support 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.

Step-by-step parent support

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

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

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska Institutet

Solna, Sweden

RECRUITING

MeSH Terms

Conditions

Problem Behavior; Oppositional Defiant Disorder; Aggression

Interventions

Methods; Palliative Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Social Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pia Enebrink, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pia Enebrink, PhD

CONTACT

+46852487738; pia.enebrink@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 30, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)