Behavioral Parenting Program for Problem Behavior

Overseen By Gabriela Peralta Reyes, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Ward of state, Severe disability

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a brief behavioral parenting program (known as Triple P, Parent Management Training, Parent-Child Interaction Therapy, or The Incredible Years) delivered through telehealth to identify families who do not improve with it. The goal is to enhance the program for those families. It is ideal for parents who speak English or Spanish, have internet access, and whose children frequently act out. As an unphased trial, it provides a unique opportunity for families to contribute to the improvement of parenting programs for diverse communities.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that this behavioral parenting program is safe?

A previous study demonstrated that programs like the Brief Behavioral Parenting Program are safe. The Triple P Positive Parenting Program and Incredible Years are examples of similar initiatives. These programs help parents and improve children's behavior by focusing on building better parent-child relationships. Research shows that participants tolerate these programs well. They do not involve medication, so there are no chemical side effects. Instead, they use techniques like setting goals and providing group support.

Participants in these programs usually report positive experiences, with no significant reports of negative effects. This suggests that the treatment is generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brief Behavioral Parenting Program because it offers a unique approach to managing problem behavior in children. Unlike traditional methods that may involve in-person sessions, this program is delivered briefly through telehealth, making it accessible and convenient for parents. The use of telehealth not only saves time but also reduces barriers like travel and scheduling conflicts. This innovative delivery method could make effective parenting support more widely available, potentially leading to better outcomes for families.

What evidence suggests that this behavioral parenting program is effective for problem behavior?

Research has shown that programs like the Behavioral Parenting Program in this trial can improve children's behavior by strengthening the parent-child bond. Studies have found that these programs teach parents effective behavior management, leading to better parenting and fewer behavior problems in children. One study found that these programs can reduce harsh and abusive parenting, benefiting the entire family. These programs can be delivered in various formats, including online, increasing accessibility for more families. Overall, evidence suggests that these programs offer a promising approach to addressing behavior issues in children. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for parents who speak English or Spanish, have internet access, and are committed to completing the treatment. Their child must exhibit significant externalizing behavior issues. Children under state custody or with severe medical/nonverbal developmental disabilities cannot participate.

Inclusion Criteria

Parent reports child has elevated externalizing concerns

Parent has access to Internet

My parent plans to finish the treatment.

Exclusion Criteria

Child is a ward of the state

My child has a severe developmental disability and cannot speak.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a brief behavioral parent training program through telehealth

12 weeks

Telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brief Behavioral Parenting Program

Trial Overview The study tests a Brief Behavioral Parenting Program delivered via telehealth to see how it helps with children's problem behaviors and parental stress. It aims to identify those who don't improve and refine the program accordingly.

How Is the Trial Designed?

Group I: Behavioral Parent Training Program Experimental Treatment 1 Intervention

The behavioral parent training intervention is delivered briefly through telehealth. It will be the only arm. It will be the only intervention received by participants in the context of this study.

Brief Behavioral Parenting Program is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Brief Behavioral Parenting Program for:

• Behavioral problems in children
• Parent-child relationship issues

Approved in European Union as Triple P for:

• Behavioral and emotional problems in children from birth to age 17

Approved in Canada as The Incredible Years for:

• Behavioral problems in children from birth to age 12

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study involving 54 behaviorally disturbed preschool-aged children, both standard and modified parent-child interaction therapy (PCIT) significantly reduced externalizing behaviors and improved parental stress and discipline practices compared to a waitlist control group.

While the standard PCIT showed superior immediate effects post-treatment, by the 6-month follow-up, both treatment groups demonstrated comparable outcomes, suggesting that abbreviated PCIT can be an effective alternative for families with young children exhibiting conduct problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-child interaction therapy: a comparison of standard and abbreviated treatments for oppositional defiant preschoolers. Nixon, RD., Sweeney, L., Erickson, DB., et al.[2022]

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 Triple P Parenting system successfully increased community awareness and provided services in at-risk areas, indicating effective implementation of the program.

Families participating in Triple P reported positive parenting experiences and child behavior problems that were below clinical levels, highlighting the program's potential efficacy in improving parenting and reducing behavioral issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The County-Wide Dissemination of Triple P Parenting Program: An Implementation Study. Baugh, EJ., Ballard, SM., Carter, L., et al.[2020]

Training general practitioners (GPs) in the Triple P-Positive Parenting Program significantly improved their consultation skills and satisfaction when working with parents, as evidenced by a study involving 32 GPs.

The training led to observable enhancements in GPs' interactional skills during simulated consultations, indicating that even brief, cost-effective programs can effectively equip healthcare providers to better address child behavioral issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training GPs in parent consultation skills. An evaluation of training for the Triple P-Positive Parenting Program. Sanders, MR., Tully, LA., Turner, KM., et al.[2019]

In a controlled study involving 280 families, parents who participated in the Triple P training showed a significant and sustained use of positive education strategies for child development one year after the training, with over 90% continuing to apply these strategies.

The study also found a notable reduction in the use of the 'time out' strategy, indicating a shift towards more constructive parenting methods following the Triple P intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[17 tips on parenting--which strategies do parents apply?]. Kuschel, A., Beslmeisl, S., Hahlweg, K., et al.[2014]

The Prevention Programme for Externalizing Problem behaviour (PEP) significantly improved parenting practices and reduced disruptive behavior in preschool children, as reported by mothers and kindergarten teachers, with positive effects noted especially for parents attending at least five training sessions.

Parents in the intervention group demonstrated increased warmth in parent-child interactions, indicating that the training not only helped manage child behavior but also enhanced the quality of parent-child relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detecting effects of the indicated prevention Programme for Externalizing Problem behaviour (PEP) on child symptoms, parenting, and parental quality of life in a randomized controlled trial. Hanisch, C., Freund-Braier, I., Hautmann, C., et al.[2009]

The Triple P Online (TPOL) program significantly improved parenting outcomes for 116 parents of children aged 2-9 with disruptive behavior, showing reductions in problem behaviors and dysfunctional parenting styles.

Improvements were maintained or even enhanced at a 6-month follow-up, indicating the long-term efficacy of this online parenting intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial evaluating the efficacy of Triple P Online with parents of children with early-onset conduct problems. Sanders, MR., Baker, S., Turner, KM.[2022]

A study involving 111 children aged 3 to 6 with subclinical behavior problems tested two versions of Parent-Child Interaction Therapy (PCIT) in pediatric primary care, showing both interventions led to significant improvements in child behavior and parenting strategies compared to baseline.

Both the 4-session group intervention (PC-PCIT) and the written guidance (PCIT-AG) were effective, with no significant differences in outcomes between the two, suggesting that either approach could be a valuable preventive strategy in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early identification and intervention for behavior problems in primary care: a comparison of two abbreviated versions of parent-child interaction therapy. Berkovits, MD., O'Brien, KA., Carter, CG., et al.[2010]

In a study involving 54 preschool-aged children with conduct problems, both standard and abbreviated Parent-Child Interaction Therapy (PCIT) showed long-term benefits, with treatment gains maintained at 1- and 2-year follow-ups for nearly all families.

The results indicate that the abbreviated form of PCIT is as effective as the standard version in helping families manage early conduct problems in children, suggesting it could be a viable option for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-child interaction therapy: one- and two-year follow-up of standard and abbreviated treatments for oppositional preschoolers. Nixon, RD., Sweeney, L., Erickson, DB., et al.[2019]

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]

A meta-analysis of 24 studies showed that both Parent-Child Interaction Therapy (PCIT) and Triple P-Positive Parenting Program effectively reduce child behavior and parenting problems, with PCIT demonstrating large effect sizes in parent-reported outcomes.

PCIT and an enhanced version of Triple P were particularly effective in improving observed child behaviors, suggesting that the choice of intervention may depend on specific goals and contexts in parenting support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral outcomes of Parent-Child Interaction Therapy and Triple P-Positive Parenting Program: a review and meta-analysis. Thomas, R., Zimmer-Gembeck, MJ.[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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10640495/

The Triple P System of Evidence-Based Parenting Support Triple P is an integrated, multi-level system of evidence-based parenting support designed to promote the well-being of children and families.

2. cdc.gov cdc.gov/parenting-toddlers/other-resources/references.html

References | Essentials for Parenting Toddlers Parent management training refers to programs that teach parents behavior management techniques and positive interaction skills.

3. incredibleyears.com incredibleyears.com/hubfs/The%20Incredible%20Years-%20Resources%20and%20Files/WP%20Files/effectiveness-of-a-parent-training-program-in-cps_10.pdf

in a child protection service Objective: This study aims to evaluate the effectiveness of a parent training program in improving parenting practices, parents' feeling of ...

4. journals.copmadrid.org journals.copmadrid.org/pi/art/pi2022a2

The Incredible Years Parenting and Child Treatment ... This study presents the first randomized controlled trial carried out in Spain to test the effectiveness of the Incredible Years Basic Parenting and Small ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352250X16302263

Incredible Years parenting interventions: current ... The primary aim of these parenting programmes is to improve child behaviour through improving parent–child relationships, reducing harsh and abusive parenting, ...

6. incredibleyears.com incredibleyears.com/hubfs/The%20Incredible%20Years-%20Resources%20and%20Files/Program%20Pages%20Files/Parent-Overview-2020%20(1).pdf

Incredible Years® (IY) Parent Programs Focus on cognitive, affective, & behavioral changes & promoting attachment. • Weekly goal setting & self-monitoring. • Weekly home activities. • Group support.

7. cebc4cw.org cebc4cw.org/program/triple-p-positive-parenting-program-system/detailed

CEBC » Triple P Positive Parenting Program System ... The overall Triple P program is a multi-tiered system of 5 levels of education and support for parents and caregivers of children and adolescents.

8. incredibleyears.com incredibleyears.com/

Incredible Years: Evidence-Based Early Intervention Programs The Incredible Years® Series is a set of interlocking, comprehensive, and developmentally-based early intervention programs for parents, teachers, and children.