PCIT + Natural Helpers for Childhood Behavior Issues

Recruiting at 1 trial location

Overseen By Natalie Espinosa, PsyD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Children under 2, adults unable to consent, prisoners

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate the effect of a time-limited (i.e., 18 weeks) community health worker (CHW) intervention, referred to as the Parent Child Interaction Therapy (PCIT) plus natural helper (NH) model, on treatment engagement, retention, and child and caregiver outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment PCIT + Natural Helpers for childhood behavior issues?

Research shows that Parent-Child Interaction Therapy (PCIT) is effective for treating behavior problems in children, including hyperactivity and oppositional-defiant issues. PCIT has been associated with lasting improvements in child behavior and parent-child interactions. ^{1 2 3 4 5}

Is Parent-Child Interaction Therapy (PCIT) safe for children?

Parent-Child Interaction Therapy (PCIT) has been studied for over 40 years and is considered safe for children, as it is a well-established treatment for behavioral issues. It has been used internationally and shown to improve child behavior and parent-child interactions without reported safety concerns. ^{1 2 3 5 6}

How is the treatment PCIT + Natural Helpers different from other treatments for childhood behavior issues?

PCIT + Natural Helpers is unique because it combines Parent-Child Interaction Therapy (PCIT) with support from 'natural helpers'—community members who provide home-based skills practice and support. This approach is designed to increase access and engagement for low-income families of color, making it more culturally and linguistically responsive compared to standard PCIT. ^{1 2 3 6 7}

Research Team

Jason Jent, PhD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for families with children aged 2-12, specifically targeting those aged 2-7 with a history of abuse or behavior issues and those aged 8-12 at risk for abuse but without significant behavior problems. Participants must not plan to move out of Miami Dade County within six months.

Inclusion Criteria

My child, aged 2-12, has a history or risk of abuse but does not show significant behavior issues.

Participants must agree that, within the upcoming six months, they will not move away to a location where they would no longer be able to regularly attend weekly sessions (i.e., moving out of Miami Dade County)

My child is between 2 and 12 years old.

Exclusion Criteria

My child is either under 2 or over 7 years old and has significant behavior issues.

Adults who are unable to consent and prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either PCIT plus Natural Helper or Standard PCIT for a maximum of 18 weeks

18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• Natural Helpers (NH)
• Standard Parent-Child Interaction Therapy (PCIT)

Trial Overview The study tests an intervention combining Parent-Child Interaction Therapy (PCIT) with support from community health workers called Natural Helpers (NH), over an 18-week period, aiming to improve engagement, retention in therapy, and outcomes for both child and caregiver.

Participant Groups

Group I: Randomized Standard-PCIT group Experimental Treatment 1 Intervention

Participants enrolled in the randomized portion of the study and randomized to receive only Standard PCIT for a maximum of 18 weeks.

Group II: Randomized PCIT plus Natural Helper group Experimental Treatment 2 Interventions

Participants enrolled in the randomized portion of the study and randomized to receive PCIT plus Natural Helper for a maximum of 18 weeks.

Group III: Opt-out Only Standard PCIT group Experimental Treatment 1 Intervention

Participants enrolled in the non-randomized portion of the study and opted in to receive only Standard PCIT for a maximum of 18 weeks.

Group IV: Opt-in PCIT plus Natural Helper group Experimental Treatment 2 Interventions

Participants enrolled in the non-randomized portion of the study and opted in to receive PCIT plus Natural Helper for a maximum of 18 weeks.

Standard Parent-Child Interaction Therapy (PCIT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Parent-Child Interaction Therapy for:

• Disruptive behavior disorders
• Conduct disorder
• Oppositional defiant disorder
• Child abuse prevention
• Parent-child relationship problems

Approved in European Union as Parent-Child Interaction Therapy for:

• Behavioral problems in children
• Parent-child interaction issues
• Child abuse prevention

Approved in Canada as Parent-Child Interaction Therapy for:

• Disruptive behavior disorders
• Parent-child relationship problems
• Child abuse prevention

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

The Children's Trust, Miami FL

Collaborator

Trials

8

Recruited

8,600+

The Children's Trust

Collaborator

Trials

5

Recruited

2,500+

ConnectFamilias

Collaborator

Trials

1

Recruited

300+

Findings from Research

Parent-Child Interaction Therapy (PCIT) is highly effective for treating behavioral problems in children aged 2 to 12, showing a significant mean effect size of -0.87 compared to control groups based on a meta-analysis of 100 studies from 1980 to 2020.

While PCIT demonstrates strong initial effectiveness, the benefits appear to diminish over time, as indicated by a smaller and non-significant effect size of -0.23 during follow-up assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of the Efficacy and Effectiveness of Parent Child Interaction Therapy (PCIT) for Child Behaviour Problems. Valero-Aguayo, L., Rodríguez-Bocanegra, M., Ferro-García, R., et al.[2021]

Direct-to-consumer advertisements for Parent-Child Interaction Therapy (PCIT) can effectively influence Spanish-speaking parents' intentions to seek help, especially when the messenger is a therapist rather than a parent.

The study highlights the importance of tailored advertising strategies to improve access to mental health services for racial and ethnic minority families, as Spanish-speaking participants showed varying help-seeking intentions based on the messenger used in the advertisements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct-to-Consumer Marketing for Parent-Child Interaction Therapy: Impact of Language and Messenger. Barnett, ML., Bernal, NA., Luis Sanchez, BE.[2022]

Parent-Child Interaction Therapy (PCIT) is viewed as an effective treatment for conduct problems in young children, but its implementation is limited in New Zealand and Australia due to barriers such as lack of access to necessary equipment and client attendance issues.

Clinicians generally feel less confident in the Parent-Directed Interaction phase, which includes time-out strategies, but concerns about time-out were not the main barrier to implementation; instead, adapting the protocol to include more emotion regulation content was common among those who tailor the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to Clinician Implementation of Parent-Child Interaction Therapy (PCIT) in New Zealand and Australia: What Role for Time-Out? Woodfield, MJ., Cargo, T., Merry, SN., et al.[2021]

Parent-Child Interaction Therapy (PCIT) is an effective intervention for childhood conduct problems, but its adoption by clinicians in routine care settings is still low despite its proven effectiveness.

This systematic review identified only three studies focused on training clinicians in PCIT, highlighting a need for more research on how to support clinicians in adopting and sustaining the use of PCIT after training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician adoption of Parent-Child Interaction Therapy: A systematic review of implementation interventions. Woodfield, MJ., Merry, S., Hetrick, SE.[2023]

Parent-child interaction therapy (PCIT) was effective in improving child behaviors and parental well-being in a real-world setting, as demonstrated by a study involving 43 families with children aged 19-52 months.

Parents reported significant improvements in their stress levels and satisfaction with the treatment after completing the PCIT program at a community-based clinic in Sydney, Australia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot evaluation of parent-child interaction therapy delivered in an Australian community early childhood clinic setting. Phillips, J., Morgan, S., Cawthorne, K., et al.[2009]

Parent-Child Interaction Therapy (PCIT) has been shown to be an effective intervention for treating disruptive behavior problems in children aged 2 to 7, with extensive research supporting its efficacy across various populations over the past decade.

Recent studies have explored adaptations of PCIT for diverse groups, including military families and trauma survivors, as well as new formats like group and home-based sessions, indicating its flexibility and potential for broader application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-Child Interaction Therapy: current perspectives. Lieneman, CC., Brabson, LA., Highlander, A., et al.[2020]

The addition of natural helper support to Parent-Child Interaction Therapy (PCIT+NH) significantly improved engagement and clinical outcomes for 42 low-income families of color, showing reductions in child behavioral issues and caregiver stress compared to the typical program population.

Higher levels of support from natural helpers were linked to better treatment engagement, indicating that culturally responsive strategies can effectively reach and benefit marginalized communities in therapeutic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Analysis of Parent-Child Interaction Therapy Plus Natural Helper Support to Increase Treatment Access and Engagement for Low-Income Families of Color. Davis, EM., Garcia, D., Rothenberg, WA., et al.[2023]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Meta-analysis of the Efficacy and Effectiveness of Parent Child Interaction Therapy (PCIT) for Child Behaviour Problems. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Direct-to-Consumer Marketing for Parent-Child Interaction Therapy: Impact of Language and Messenger. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Barriers to Clinician Implementation of Parent-Child Interaction Therapy (PCIT) in New Zealand and Australia: What Role for Time-Out? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Clinician adoption of Parent-Child Interaction Therapy: A systematic review of implementation interventions. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Pilot evaluation of parent-child interaction therapy delivered in an Australian community early childhood clinic setting. [2009]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Parent-Child Interaction Therapy: current perspectives. [2020]

7. England pubmed.ncbi.nlm.nih.gov

A Preliminary Analysis of Parent-Child Interaction Therapy Plus Natural Helper Support to Increase Treatment Access and Engagement for Low-Income Families of Color. [2023]