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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Parent-Child Interaction Therapy (PCIT) combined with support from community health workers, known as Natural Helpers, compared to standard PCIT alone. The researchers aim to determine if this additional support improves treatment adherence and benefits child behavior and caregiver outcomes. It suits families with children aged 2 to 12 who have experienced abuse, neglect, or behavior issues and reside in Miami Dade County. Participants must attend weekly sessions for up to 18 weeks. As an unphased study, this trial provides families the chance to explore innovative support methods that could enhance treatment success.

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 prior data suggests that the PCIT plus Natural Helper model is safe for children and caregivers?

Research has shown that Parent-Child Interaction Therapy (PCIT) is a well-known and generally safe treatment for children. For many years, PCIT has helped reduce disruptive behaviors in children and strengthen the parent-child relationship. Studies have found that it not only improves children's behavior but also lowers stress for caregivers.

Adding Natural Helpers, who are community health workers, to PCIT aims to boost participation and results. Although specific information about the safety of combining PCIT with Natural Helpers is limited, PCIT alone has a strong safety record. This suggests that the combined approach should also be safe, as it builds on a proven method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PCIT plus Natural Helper approach because it builds on the well-established Parent-Child Interaction Therapy (PCIT) by integrating community support. Unlike standard PCIT, which focuses solely on improving parent-child interactions through structured sessions, this new method incorporates "Natural Helpers" — community members trained to provide additional guidance and support to families. This unique combination aims to enhance the effectiveness and accessibility of treatment for childhood behavior issues by leveraging familiar and trusted community networks. By involving these local support figures, the approach hopes to foster a more comprehensive and sustainable improvement in children's behavior.

What evidence suggests that this trial's treatments could be effective for childhood behavior issues?

Research shows that Parent-Child Interaction Therapy (PCIT) reduces behavior problems in children and enhances parenting skills. Studies have found that children behave better and parents adopt more positive parenting techniques after PCIT. In this trial, some participants will receive only Standard PCIT, while others will receive PCIT combined with "Natural Helpers," such as community health workers. Early findings suggest that adding Natural Helpers to PCIT can enhance engagement and outcomes. Both methods aim to improve results for children and caregivers, with strong evidence supporting the main PCIT approach. ^{1 4 5 6 7}

Who Is on the Research Team?

Jason Jent, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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) 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]

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8903162/

A Preliminary Analysis of Parent-Child Interaction Therapy ... The current study investigated the impact of partnering with natural helpers, a lay health worker model, to increase access, engagement, and retention in one ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190740922000068

A preliminary analysis of parent-child interaction therapy ... A community-based natural helper PCIT model (PCIT + NH) to improve engagement, retention, and child and caregiver outcomes.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10213097/

A Natural Helper Intervention to Address Disparities in ... This study incorporated natural helpers who had been trained as community health workers into PCIT delivery to improve disparities in engagement and outcomes.

4. tandfonline.com tandfonline.com/doi/abs/10.1080/15374416.2022.2148255

A Natural Helper Intervention to Address Disparities in ... This study incorporated natural helpers who had been trained as community health workers into PCIT delivery to improve disparities in engagement and outcomes.

5. researchgate.net researchgate.net/publication/366364755_A_Natural_Helper_Intervention_to_Address_Disparities_in_Parent_Child-Interaction_Therapy_A_Randomized_Pilot_Study

A Natural Helper Intervention to Address Disparities in ... This study incorporated natural helpers who had been trained as community health workers into PCIT delivery to improve disparities in engagement ...

6. withpower.com withpower.com/trial/phase-parenting-11-2018-0dd1b

PCIT + Natural Helpers for Childhood Behavior Issues 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 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0145213422004768

Outcomes of Parent-Child Interaction Therapy (PCIT) for ... PCIT was an effective treatment in improving a variety of child and parent outcomes in this population including reduced parenting stress, child behavior ...