Parent-Child Interaction Therapy for Disruptive Behaviors

(RAINBOW Trial)

Overseen By Viviana Rodriguez

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Epilepsy surgery, Communication skills, others

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

Compensation: Varies

Number of Visits: 25

Duration: 20 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The RAINBOW study is a fully remote study focused on understanding and treating behavior problems in young children with tuberous sclerosis complex (TSC). The first goal is to enroll a group of 100 children with TSC between the ages of 3 and 6 years old, with and without problem behaviors, to learn about how best to measure behavioral challenges in TSC and how common these behaviors are during this age period. All families will get feedback from the clinical assessments collected. Eligible children who are experiencing behavior problems will be invited to enroll in a pilot clinical trial of internet-based Parent-Child Interaction Therapy (or PCIT), which is meant to help parents better manage their children's challenging behaviors. Adaptations to PCIT are incorporated to suit the needs of TSC children and families. Some participants will be randomly selected to receive the intervention immediately and others after a 6-month delay, but all families will receive the same intervention. Intervention sessions occur on a weekly basis for up to 20 weeks. Follow-up assessments, which include play interactions, parent interviews, and questionnaires occur about 3 and 6 months after the first visit. The delayed treatment group has an extra brief assessment about 12 months from the initial visit. This study will increase what is known about the types of behavior problems that come up during preschool age in TSC and how best to help children and families with TSC who are experiencing these problems.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on behavioral therapy, so it's likely you can continue your medications, but you should confirm with the study team.

What data supports the effectiveness of the treatment Parent-Child Interaction Therapy (PCIT) for disruptive behaviors?

Research shows that Parent-Child Interaction Therapy (PCIT) is effective in treating disruptive behavior problems, hyperactivity, and oppositional-defiant issues in children. It has been studied internationally and found to be beneficial for various behavioral and emotional issues, including conduct problems and child physical maltreatment. ^{1 2 3 4 5}

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

The research does not specifically address safety concerns, but PCIT has been widely studied and used for over 40 years, suggesting it is generally considered safe for treating behavioral issues in children. ^{1 2 3 4 6}

How is Parent-Child Interaction Therapy (PCIT) different from other treatments for disruptive behaviors?

Parent-Child Interaction Therapy (PCIT) is unique because it focuses on improving the parent-child relationship through guided interactions, which helps address disruptive behaviors in young children. Unlike other treatments, PCIT involves real-time coaching of parents to enhance their skills in managing their child's behavior, making it a hands-on and interactive approach. ^{1 2 3 4 7}

Research Team

Nicole McDonald, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for children aged 3-6 with tuberous sclerosis complex (TSC), both with and without behavior problems. To participate, kids must have a diagnosis of TSC. The study aims to help those struggling with disruptive behaviors by using internet-based therapy tailored for TSC families.

Inclusion Criteria

My child has high behavior issues and I can join in Parent-Child Interaction Therapy.

Exclusion Criteria

I am planning to have epilepsy surgery and my communication skills are like those of a child younger than 18 months.

For assessment visit: None

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Baseline Assessment

Initial assessments of developmental abilities and behavior problems using parent report measures and video recordings

1 week

1 visit (virtual)

Treatment

Internet-based Parent-Child Interaction Therapy (PCIT) sessions conducted weekly

20 weeks

20 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including play interactions, parent interviews, and questionnaires

6 months

3 visits (virtual) at 3, 6, and 12 months for delayed group

Treatment Details

Interventions

• Parent-Child Interaction Therapy (PCIT)

Trial Overview The RAINBOW study tests an adapted version of Parent-Child Interaction Therapy (PCIT) delivered online to manage challenging behaviors in young children with TSC. Participants are randomly chosen to start treatment immediately or after a six-month wait, but all will receive the same therapy sessions weekly for up to 20 weeks.

Participant Groups

Group I: Immediate Treatment Experimental Treatment 1 Intervention

Participants randomized to the immediate treatment condition will receive written and verbal feedback after the baseline assessment visit. These families will begin PCIT shortly after this visit. These families will participate in follow-up visits at 3 and 6 months after the baseline visit.

Group II: Waitlist Control Active Control 1 Intervention

Participants randomized to the waitlist control (or delayed treatment) condition will receive written and verbal feedback after the baseline assessment visit. These families will participate in follow-up visits at 3 months, 6 months, and 12 months after the baseline visit. They will receive the same treatment (PCIT) after the 6-month assessment.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

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 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) 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]

Parent-child interaction therapy (PCIT) was successfully applied to an 11-year-old boy with externalizing behaviors following a severe traumatic brain injury, demonstrating its adaptability beyond the typical age range.

After 9 sessions of PCIT, the child showed a significant reduction in negative behaviors, and his mother experienced less distress, indicating the therapy's effectiveness in improving family dynamics post-injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-child interaction therapy as a family-oriented approach to behavioral management following pediatric traumatic brain injury: a case report. Cohen, ML., Heaton, SC., Ginn, N., et al.[2012]

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) was effective in improving disruptive behaviors in two kindergarten children with significant functional impairments due to ADHD and frontal lobe epilepsy, with 17 and 25 therapy sessions respectively.

Both sets of parents achieved mastery criteria in the therapy, indicating that PCIT can be a valuable intervention for young children with externalizing symptoms, even when some sessions were conducted virtually during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Parent-Child Interaction Therapy (PCIT) in Children with Attention Problems, Hyperactivity, and Impulsivity in Dubai. Al Sehli, SA., Helou, M., Sultan, MA.[2021]

References

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

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

2. Spain pubmed.ncbi.nlm.nih.gov

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

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

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

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

Parent-child interaction therapy as a family-oriented approach to behavioral management following pediatric traumatic brain injury: a case report. [2012]

6. England pubmed.ncbi.nlm.nih.gov

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

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

The Efficacy of Parent-Child Interaction Therapy (PCIT) in Children with Attention Problems, Hyperactivity, and Impulsivity in Dubai. [2021]