Internet-delivered Parent-Child Interaction for Parents of Children 2-7 Years With Disruptive Behaviors

NCT ID: NCT06828302

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2026-06-15

Brief Summary

The goal of this feasibility study is to evaluate feasibility of Internet-delivered Parent-Child Interaction Therapy for parents of children 2-7 years with disruptive behaviors. The main questions it aims to answer are:

1. Could a brief online version of PCIT (iPCIT) be feasible for reducing disruptive behaviors and internalizing problems in young children, and for improving the quality of parent-child interaction?

2. How is iPCIT experienced by participating parents?

Participants will receive a 10-week online intervention of Parent-Child Interaction Therapy and answer questionnaires online weekly.

Detailed Description

Severe early behavioral problems increase the risk of impaired functioning in childhood and later life. Parent-Child Interaction Therapy (PCIT) is particularly effective for young children (age 2-7) with disruptive behaviors but is unimplemented in Sweden. Barriers to PCIT implementation include time constraints for parents and therapist challenges. An abbreviated internet-delivered version, iPCIT, may address these barriers. The objective of the study is to evaluate feasibility and acceptability of iPCIT.

Research questions

This study will use an uncontrolled pretest-posttest design, all participants will receive the intervention. The intervention consists of 10 weekly modules delivered over the Internet with guided support from an experienced CBT-trained psychologist and 5 biweekly videosessions where parents practice parental skills in a play situation with their child while receiving feedback and support from their therapist.

Assessments will be made pretreatment, weekly during treatment for the primary outcome and potential mediators, posttreatment, at the primary endpoint 2 months after treatment completion and at follow up 6 months after treatment completion. Twenty participants (parents of children aged 2-7 years) will be included. All outcome data will be collected digitally and include for feasibility: treatment credibility, working alliance, compliance with the treatment (number of modules completed), any adverse events, subjective overall relief and satisfaction with treatment. For potential efficacy, the clinical effect in the group will be analyzed on pre- to post-measurements, including weekly measurements and 2 months follow up after treatment termination (primary endpoint). The participants will be followed 6 months after treatment completion to analyze long term clinical effects.

Conditions

Disruptive Behavior

Study Design

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

Study Groups

iPCIT

Online parent management training (PMT) to teach parental skills (10 weekly online modules) combined with videosession for coaching of parental skills (5 biweekly sessions)

Group Type: OTHER

Internet-delivered Parent-Child Interaction Therapy

Intervention Type: BEHAVIORAL

Parent management training delivered online where Internet-modules are combined with video sessions for live coaching.

Interventions

Internet-delivered Parent-Child Interaction Therapy

Parent management training delivered online where Internet-modules are combined with video sessions for live coaching.

Intervention Type: BEHAVIORAL

Other Intervention Names

Internet-CBT; Internet-delivered cognitive behavior therapy

Eligibility Criteria

Inclusion Criteria

• Children aged 2-7 years
• Disruptive behaviors as assessed with Eyberg Child Behavior Inventory (ECBI) ≥126 for boys and ≥121 for girls (which corresponds to the 90th percentile according to Swedish norms)
• Language ability equivalent to at least an average 2-year-old, defined as a vocabulary of ≥ 25 word and ability to understand simple instructions, assessed with a language screening form

Exclusion Criteria

• Severe autism spectrum condition (autism level 2 or 3 or equivalent functioning)
• parents who are not proficient enough in the Swedish language to complete questionnaries and receive therapy without an interpreter
• Presence of severe parental psychiatric disorders such as psychosis or suicidal ideations
• Ongoing severe psychosocial distress such as custody dispute.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Marianne Bonnert

PhD, lic psych, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marianne Bonnert, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Stockholm Sweden

Locations

Centre for Psychiatry Research, Karolinska Institutet

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

EPM Dnr: 2024-06544-01

Identifier Type: -

Identifier Source: org_study_id