Hybrid Pilot of Personalized Parent-Child Interaction Therapy

NCT07887295 | Not Yet Recruiting

• 2 other identifiers: IRB-26-179R01MH144540
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn whether a personalized version of Parent-Child Interaction Therapy (PCIT), called MY PCIT, can improve treatment fit, treatment participation, and outcomes for young children with behavior problems and their caregivers. The main questions this study aims to answer are:

• How does standard PCIT compare to MY PCIT in keeping families engaged in treatment and improving treatment outcomes?
• How does standard PCIT compare to MY PCIT in aligning treatment and families' beliefs and values? Researchers will compare standard PCIT to MY PCIT to learn how the personalized approach can be delivered in community mental health settings, and whether it may improve treatment fit, reduce treatment dropout, and improve outcomes for children and their caregivers. Participating families will:
• Receive standard PCIT or MY PCIT
• Complete four sets of online surveys: one before treatment, two during treatment, and one after treatment The surveys will ask about the child's behavior and the family's beliefs, values, and treatment experiences. Researchers will also gather feedback from therapists to help improve how MY PCIT can be delivered and sustained in community mental health sites.

Conditions

Disruptive Behaviors

Keywords

Parent-Child Interaction Therapy; Personalized Treatment; Behavioral Parent Training; Community Mental Health Settings; Behavior Problems

Outcome Measures

Primary Outcomes (5)

• Eyberg Child Behavior Inventory (ECBI)

  1. Baseline 2. Post-treatment (on average week 14)

• Child Behavior Checklist (CBCL)

  1. Baseline 2. Post-treatment (on average week 14)

• Therapist Weekly Check-In

  Weekly from the start of treatment (week 1) to post-treatment (an estimated average of week 14)

• Fidelity to PCIT and Fidelity to MY PCIT

  Fidelity to PCIT will be assessed across both conditions using previously validated measures developed by Dr. Eyberg for use with PCIT (Eyberg \& Members of the Child Study Laboratory, 1999). Independent coders, masked to condition, will score treatment fidelity via videotape observation. Fidelity to MY PCIT will also be assessed using procedures previously developed.

  Weekly from the start of treatment (week 1) to post-treatment (an estimated average of week 14)

• My Thoughts about Therapy (MTT)

  1. Baseline 2. After CDI Teach (Week 1) 3. After PDI Teach (on average week 8) 4. Post-treatment (on average week 14)

Secondary Outcomes (4)

• Dyadic Parent Child Interaction Coding System-IV (DPICS)

  1. Baseline 2. Post-treatment (on average week 14)

• Parenting Stress Index (PSI)

  1. Baseline 2. Post-treatment (on average week 14)

• Therapy Attitude Inventory (TAI)

  1. After CDI Teach (Week 1) 2. After PDI Teach (on average week 8) 3. Post-treatment (on average week 14)

• Parent Explanatory Model - Treatment Explanatory Model Match (PEM-TEM Match)

  1. Baseline 2. After CDI Teach (Week 1) 3. After PDI Teach (on average week 8) 4. Post-treatment (on average week 14)

Study Arms (2)

Standard PCIT

ACTIVE COMPARATOR

Parent-Child Interaction Therapy (PCIT) is a behavioral parent training intervention developed by Dr. Sheila Eyberg for young children (aged 2-7) with disruptive behavior problems. It is a well-established, evidence-based intervention that uses a live coaching model in which therapists use a one-way mirror or similar set-up to coach parents in specialized parenting skills in their interactions with their children. The intervention involves 2 segments: (1) Child Directed Interaction (CDI) focuses upon developing a positive, warm relationship between parent and child and using selective attention effectively. (2) Parent Directed Interaction (PDI) focuses upon teaching parents how to provide consistent and effective discipline.

Behavioral: Behavioral Parent Training

MY PCIT (a personalized version of PCIT)

EXPERIMENTAL

MY PCIT is a version of PCIT that is personalized to each family with the aim to increase the match between the treatment's beliefs/values and the family's beliefs/values. MY PCIT includes an assessment of parental beliefs/values that will then guide adaptations to the delivery of PCIT.

Behavioral: Behavioral Parent Training

Interventions

Behavioral Parent Training BEHAVIORAL

Parent-Child Interaction Therapy

MY PCIT (a personalized version of PCIT); Standard PCIT

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Caregiver 18 years or over
• Caregiver seeking therapy for a child with behavior problems through a community mental health service agency that is participating in the study
• Families are determined to be appropriate for the study by the participating community mental health service agency.
• Child 2-6 years of age
• Child has an ECBI intensity score in the clinical range

Sponsors & Collaborators

• San Diego State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

San Diego Center for Children

San Diego, California, 92111, United States

Location

Rady Children's Hospital Outpatient Psychiatry

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Problem Behavior; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• May Yeh

  San Diego State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

May Yeh, PhD

CONTACT

619-594-2838; myeh@sdsu.edu

Argero Zerr, PhD

CONTACT

805-437-3749; argero.zerr@csuci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified data will be submitted and made available according to the timelines and procedures established by the NIMH Data Archive and the study's Data Management and Sharing Plan. Data will remain available for as long as they are maintained by the NDA.
• Access Criteria: Qualified researchers may request access to the de-identified data through the NIMH Data Archive.

Locations

US (2)