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

NCT ID: NCT07201090

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-12-31

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. How feasible and acceptable is the implementation of brief PCIT-VR in Sweden?

2. What are the preliminary effects of brief PCIT-VR?

3. How do parents and clinicians experience brief PCIT-VR?

Families at child and adolescent psychiatry clinics will receive up to 10 PCIT sessions. Caregivers complete quantitative assessments before, during, after treatment, and at 6-months follow-up, and are asked to participate in interviews after PCIT. Feasibility and acceptability of brief PCIT VR is evaluated, as well as effectiveness outcomes, including changes in child disruptive behavior and parenting skills. Within-group analyses will examine trends in outcome measures over time.

Detailed Description

BACKGROUND:

Persistent and clinically significant behavior problems are associated with long-term negative outcomes if left untreated. Early and effective interventions are critical for children's development and to reduce long-term societal costs.

Parent training programs are the most effective evidence-based interventions for children under 12 years with externalizing behavior problems. Parent-Child Interaction Therapy (PCIT) is one of the most rigorously evaluated programs for children aged 2-7 years. PCIT is distinctive in that it uses live coaching, where the therapist guides parents in real time as they interact with their child. Several meta-analyses demonstrate large effects of PCIT in reducing child disruptive behavior and improving parenting skills.

However, both the length of PCIT treatment and dropout rates remain challenges. The PCIT protocol often requires 15-25 sessions, and high attrition rates have been reported in routine care. Promisingly, research suggests that PCIT can still be effective when families end treatment early or when time-limited PCIT protocols are used. Further evaluations are needed to understand how effectiveness in briefer treatment formats can be maintained.

Using films and videos for parenting skills modelling, and virtual reality (VR) for practice may enhance skill learning and allow parents to continue practicing outside therapy sessions. VR can provide realistic training opportunities, enabling parents to observe and rehearse parenting skills. A study in the Netherlands has used VR in PCIT with promising results.

This study will implement and evaluate a time-limited (shortened) PCIT format combined with VR and film-based components (brief PCIT-VR). By limiting treatment to 10 sessions and supplementing with these pedagogical tools, the intervention aims to balance effectiveness with feasibility.

PURPOSE AND RESEARCH QUESTIONS:

This study will evaluate preliminary effects, aspects of feasibility, and experiences with brief PCIT-VR.

Research questions:

1. How feasible and acceptable is the implementation of brief PCIT-VR in Sweden?

2. What are the preliminary effects of brief PCIT-VR?

3. How do parents and clinicians experience brief PCIT-VR?

METHOD:

This study will use a Single-Case Experimental Design (SCED).

Participants will be families including parents of children aged 2-7 years who present with disruptive behavior problems according to >114 on the Eyberg Child Behavior Inventory (ECBI). Families will be recruited through child and adolescent psychiatry clinics in Sweden. Clinicians working at these clinics will provide initial information about the study orally and in writing. Parents who express interest will be directed to an online portal where they receive written information. Both legal guardians provide written informed consent before participation. Parents fill out the ECBI to inform whether they meet inclusion criteria. A person from the research group contacts the family to provide more information and inform about inclusion or exclusion. If families are included, they are provided with login to a platform where they respond to weekly measurements, baseline/post treatment measurements, and during the treatment phase have access to video vignettes illustrating parenting skills. Parents will also have access to brief virtual reality-films at the clinic together with the therapist during two PCIT-sessions.

The study consists of three main phases: baseline, treatment, and follow-up. During the baseline phase (before treatment starts during approximately three weeks) and during the treatment phase, parents complete weekly questionnaires. In the middle of the treatment, parents respond to a longer measurement (ECBI). Before and after treatment, a larger battery of questions are administered (pre-, post- treatment, and 6-month follow-up assessments).

Each week during PCIT, parents are given access to a new module in the online platform with video vignettes of parenting skills, supplementing the session. The treatment phase involves up to 10 PCIT sessions. Semi-structured qualitative interviews will be conducted with both parents and clinicians after treatment to explore experiences, feasibility, and acceptability.

SAMPLE SIZE CALCULATION:

We aim to include a target of 15 families (approximately 15-30 parents), in line with SCED-study standards and similar SCED studies conducted internationally.

ANALYSES:

Quantitative data will be analyzed using visual inspection of weekly SCED graphs and statistical methods such as percent change calculations, Reliable Change Index analyses, and repeated-measures analyses of variance (ANOVA). Benchmarking will be used to compare outcomes with those from longer PCIT trials reported in the literature. Qualitative interview data will be analyzed thematically to identify key themes regarding feasibility, acceptability, and barriers and facilitators to implementation.

Conditions

Conduct Disorders in Children; Disruptive Behavior; Oppositional Defiant Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Brief PCIT-VR

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 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

Region Stockholm

Stockholm, , Sweden

Countries

Sweden

Central Contacts

Pia Enebrink, PhD

Role: CONTACT

pia.enebrink@ki.se

+46852487738

Facility Contacts

Pia Enebrink, PhD

Role: primary

Other Identifiers

2024-08744-01

Identifier Type: -

Identifier Source: org_study_id