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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand and treat behavior problems in young children with tuberous sclerosis complex (TSC), a genetic disorder. It tests an internet-based therapy called Parent-Child Interaction Therapy (PCIT), which helps parents manage their children's challenging behaviors. Some children will start the therapy immediately, while others will begin after a 6-month delay, but all will eventually receive the same care. Children aged 3 to 6 years with TSC who face behavior challenges at home and have a parent available for therapy sessions might be a good fit for this study. As an unphased trial, this study offers families the chance to access innovative therapy that could significantly improve their child's behavior.

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 prior data suggests that Parent-Child Interaction Therapy (PCIT) is safe for children with TSC?

Research shows that Parent-Child Interaction Therapy (PCIT) is generally safe and well-tolerated. Studies have demonstrated that PCIT effectively reduces challenging behaviors in children. For instance, one study reported significant improvements in children's behavior and a decrease in parenting stress. These positive results suggest that PCIT works well without needing major changes for different groups.

Additionally, PCIT has succeeded in various settings, including with children in foster care. This widespread success indicates its safety and effectiveness. While this study phase does not provide specific safety data, the use of PCIT with different groups supports its safety for children with behavior issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Parent-Child Interaction Therapy (PCIT) is unique because it focuses on improving the parent-child relationship as a means to address disruptive behaviors. Unlike typical treatments that may rely on medication or individual therapy for the child, PCIT involves both the parent and child in real-time coaching sessions to enhance their communication and interaction skills. Researchers are excited about this approach because it empowers parents with effective tools and strategies to manage challenging behaviors, potentially leading to long-lasting positive changes in the family dynamic. This therapy not only targets the child's behavior but also strengthens the emotional bond between parent and child, which can be crucial for sustained behavioral improvement.

What evidence suggests that Parent-Child Interaction Therapy might be an effective treatment for behavior problems in children with TSC?

Studies have shown that Parent-Child Interaction Therapy (PCIT) reduces disruptive behaviors in children. Research indicates significant improvement in children's behavior problems, with parents noticing fewer issues after completing the therapy. One study found that all groups using PCIT experienced better child behavior and improved parenting skills. Another analysis showed that PCIT leads to important changes that last over time. In this trial, participants will either receive immediate PCIT treatment or be placed on a waitlist control, receiving PCIT after a delay. Although PCIT hasn't been specifically studied for children with tuberous sclerosis complex (TSC), its success with other disruptive behavior disorders suggests it could also help with TSC-related behavior issues. ^{1 6 7 8 9}

Who Is on the Research Team?

Nicole McDonald, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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 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]

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11818805/

Parent–Child Interaction Therapy for Disruptive Behavior Research studies demonstrate that PCIT is effective across a variety of DBP conditions, showing significant reductions in child behavioral problems and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5530857/

Parent–Child Interaction Therapy: current perspectives - PMC Results have indicated decreased child disruptive behavior problems on the Eyberg Child Behavior Inventory (ECBI) at posttreatment. High rates (100%) of child ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190740925005183

Understanding parent-child interaction therapy outcomes ... All groups demonstrated significant improvements in caregiver-reported child disruptive behaviors and observed positive parenting skills from ...

4. parentchildinteractiontherapy.com parentchildinteractiontherapy.com/research-treatment-outcomes

Treatment Outcomes | Parent Child Interaction Therapy Benefits include clinically significant improvements on multiple measures of disruptive behavior and strong maintenance data, suggesting the PCIT is an ...

5. psicothema.com psicothema.com/pdf/4701.pdf

Meta-analysis of the Efficacy and Effectiveness of Parent ... Parent-Child Interaction Therapy (PCIT) is a behavioural therapy that is an alternative to classical intervention for children with behavioural problems and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10894622/

Randomized Trial of Parent–Child Interaction Therapy ... This randomized trial presents the first evidence that PCIT improves inhibitory control and emotion regulation in a child welfare parents.

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

Outcomes of Parent-Child Interaction Therapy (PCIT) for ... Treatment outcomes include lower parenting stress, reduced recidivism of abuse, decreased problematic child behaviors, and improved caregiver mental health ( ...

8. publications.aap.org publications.aap.org/pediatrics/article-abstract/140/3/e20170352/38296

Parent-Child Interaction Therapy: A Meta-analysis Meta-analyses from PCIT studies reveal that robust positive outcomes and content modification may not be necessary for diverse populations.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0190740922004339

Parent-child interaction therapy for children in foster care ... Results demonstrate that PCIT can be similarly effective in reducing problematic behaviors for children placed in foster care when compared to children not in ...