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

Trial Summary

What is the purpose of this trial?

This study will look at who does not improve after doing a behavioral parent training program briefly through telehealth. It will also study ways to make the intervention better for those that do not improve.

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 data supports the effectiveness of the treatment Behavioral Parenting Program for Problem Behavior?

Research shows that Parent-Child Interaction Therapy (PCIT) and the Triple P-Positive Parenting Program are effective in reducing child behavior problems and improving parenting practices. Studies indicate that both standard and abbreviated forms of PCIT maintain long-term benefits, and Triple P has moderate to large positive effects on parent-reported outcomes. ^{1 2 3 4 5}

Is the Behavioral Parenting Program safe for humans?

Research on Parent-Child Interaction Therapy (PCIT) and its variations shows that these programs are generally safe for families, with no significant safety concerns reported in studies. They have been used successfully to address behavior problems in young children, and improvements in child behavior and parenting strategies have been observed without adverse effects. ^{3 4 5 6 7}

How is the Behavioral Parenting Program for Problem Behavior treatment different from other treatments?

The Behavioral Parenting Program, including Triple P and similar methods, is unique because it focuses on enhancing parents' skills and confidence to manage their children's behavior, rather than directly treating the child. This approach empowers parents to create a positive home environment, which can lead to long-term improvements in child behavior. ^{8 9 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Behavioral outcomes of Parent-Child Interaction Therapy and Triple P-Positive Parenting Program: a review and meta-analysis. [2022]

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

Parent-child interaction therapy: one- and two-year follow-up of standard and abbreviated treatments for oppositional preschoolers. [2019]

4. England 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. [2010]

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

Parent-child interaction therapy: a comparison of standard and abbreviated treatments for oppositional defiant preschoolers. [2022]

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

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

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

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

8. Germany pubmed.ncbi.nlm.nih.gov

[17 tips on parenting--which strategies do parents apply?]. [2014]

9. United States 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. [2009]

10. Australia pubmed.ncbi.nlm.nih.gov

Training GPs in parent consultation skills. An evaluation of training for the Triple P-Positive Parenting Program. [2019]

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

The County-Wide Dissemination of Triple P Parenting Program: An Implementation Study. [2020]

12. England 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. [2022]