Effects and Implementation of a Brief Version of Parent-Child Interaction Therapy

NCT07201090 | Not Yet Recruiting

• 1 other identifier: 2024-08744-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to evaluate the effects and feasibility of a shortened version of Parent-Child Interaction Therapy (PCIT), supplemented with video vignettes of parenting skills and 360-virtual reality (VR)-films for parents of children aged 2-7 years with disruptive behavior problems. The main questions the study aims to answer, using a Single-Case Experimental Design, are:

1. 1.How feasible and acceptable is the implementation of brief PCIT-VR in Sweden?
2. 2.What are the preliminary effects of brief PCIT-VR?
3. 3.How do parents and clinicians experience brief PCIT-VR?

Conditions

Conduct Disorders in Children; Disruptive Behavior; Oppositional Defiant Disorder

Keywords

Parent training; Parent-Child Interaction Therapy; Virtual reality

Outcome Measures

Primary Outcomes (3)

• Mean change from screening in parent-ratings of child behavior problems on the Eyberg Child Behavior Inventory (ECBI) - Intensity scale

  Measures frequency of externalizing behaviors in children. The scale includes 36 items which are rated on a 7-point-scale (1 to 7). The total scale sum ranges from minimum 36 to a maximum sum of 252. Higher score indicates more disruptive behavior problems.

  Screening (at inclusion), pre-treatment (treatment phase week 0), mid treatment (treatment phase week 6), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)

• Mean change from screening in parent-ratings of child behavior problems on the Eyberg Child Behavior Inventory - Problem scale

  Measures externalizing behaviors in children. The scale includes 36 items which are rated yes/no (1-0), indicating whether the behavior is experienced as problematic. Minimum summary score is 0, maximum score is 36. Higher score indicates more disruptive behavior problems.

  Screening (at inclusion), pre-treatment (treatment phase week 0), mid treatment (treatment phase week 6), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)

• Change from baseline phase to treatment phase in weekly reported disruptive behavior

  Three weekly questions on disruptive behavior rated on an 8 point scale from 0-7. Minimum summary score is 0, maximum score is 21. Higher score indicates more disruptive behaviors.

  Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10).

Secondary Outcomes (9)

• Mean change from pre-treatment in parent-rated callous unemotional behaviors on the Inventory of Callous Unemotional traits (ICU) scale

  Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10)

• Mean change from pre-treatment in parent-rated stress on the Perceived Stress Scale (PSS)

  Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)

• Mean change from pre-treatment in parent-rated parenting behaviors on the Parenting Young Children (PARYC) - frequency scale

  Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)

• Mean change from pre-treatment in parent-rated parenting behaviors on the Parenting Young Children (PARYC) - problem scale

  Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)

• Change from baseline phase to treatment phase in weekly reported warmth and relationship quality

  Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10).

Other Outcomes (8)

• Post treatment satisfaction on the Therapy Attitude Inventory

  Post-treatment (treatment phase 10 weeks)

• Parental experiences of the treatment explored through individual qualitative interviews

  Post-treatment (treatment phase 10 weeks)

• Clinician experiences of the treatment explored through individual qualitative interviews

  Post-treatment (treatment phase 10 weeks)

Study Arms (1)

Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films

EXPERIMENTAL

10 sessions of Parent-Child Interaction Therapy (PCIT), supplemented with brief role-modeling videos of parenting skills, provided through an online project platform, and virtual reality (360-degree VR)-films shown during treatment sessions.

Behavioral: Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films

Interventions

Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films BEHAVIORAL

10 sessions of PCIT delivered by trained psychologists, supplemented with videos and 360-degree VR-films Sessions follow the standard PCIT structure, with an initial phase focused on child-directed interaction, followed by a second, modified phase, focused on parent-directed interaction. To support skill learning, families are provided with digital materials including conventional video modules at home and 360-degree virtual reality (VR) films. The VR films are shown during two sessions at the clinic. Additional videos are available online through a platform for parents to view and practice between sessions. These tools allow parents to rehearse skills flexibly in their home environment and reinforce the in-session training.

Also known as: Brief PCIT-VR

Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child aged 2-7 years
• Elevated disruptive behavior (ECBI score \>114)
• Parent speaks Swedish or English

You may not qualify if:

• Child or family requiring more urgent intervention
• Parent condition that prevents VR use (e.g., epilepsy, severe migraine, adverse VR experiences)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (2)

Karolinska Institutet

Solna, Sweden

Location

Region Stockholm

Stockholm, Sweden

Location

MeSH Terms

Conditions

Problem Behavior; Oppositional Defiant Disorder

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 1, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)