Family Life Skills Program for Childhood Behavior

Overseen By Ellen Rebekah Siceloff, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Disqualifiers: Cognitive disability, Developmental delay, Psychotic symptoms, others

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: 13

Duration: 16-18 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a 12-session program designed to help parents teach skills that improve their young child's mood, behavior, and lifestyle. The Family Life Skills Triple P, also known as the Positive Parenting Program, targets families facing major stressors such as trauma, mental health issues, HIV, racial discrimination, substance misuse, or financial challenges. Families with a child aged 3-9 years, where the parent or caregiver is concerned about the child and experiencing two or more of these stressors, may be well-suited for the program. Participants will either join the program immediately or be placed on a waitlist to join later. As an unphased trial, this study provides families with the opportunity to access potentially beneficial support and resources tailored to their unique challenges.

Will I have to stop taking my current medications?

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

What prior data suggests that the Family Life Skills Triple P program is safe for children?

Research has shown that the Family Life Skills Triple P program is generally safe and well-received. Triple P, a well-known parenting support system used worldwide, helps improve the well-being of children and families by offering parenting tips.

Studies have found that Triple P can lower rates of child abuse, reduce the need for foster care, and decrease hospital visits due to child abuse injuries. These findings suggest it effectively supports families without causing harm. No major negative effects have been reported in these studies, indicating the program is safe for participating families.

Overall, the program aims to enhance parenting skills through a gentle and non-invasive method, making it a low-risk choice for families facing challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Life Skills Triple P program because it offers a fresh approach to improving childhood behavior by focusing on empowering parents. Unlike traditional treatments that might rely on medications or individual therapy for the child, this program is a parent-based prevention strategy. It provides parents with practical skills through 12 structured sessions, helping them effectively manage and improve their child's behavior. This unique focus on parental involvement and skill-building stands out as a promising method to create lasting behavioral change in children.

What evidence suggests that the Family Life Skills Triple P program is effective for improving childhood behavior?

Research has shown that the Family Life Skills Triple P program, provided to participants in the intervention arm of this trial, effectively improves children's behavior and reduces parenting stress. Studies indicate moderate to large positive changes in child behavior and parenting practices. The program also helps lower the risk of child abuse. A review of similar Triple P programs found they effectively manage behavioral problems. Overall, evidence supports that this program can enhance children's social and emotional well-being. ^{1 2 3 5 6}

Who Is on the Research Team?

Nada M Goodrum, Ph.D.

Principal Investigator

University of South Carolina

Are You a Good Fit for This Trial?

This trial is for parents or guardians of children aged 3-9 who are concerned about their child's mood, behavior, or lifestyle health. Participants must be over 18, speak English, and be facing two or more stressors like trauma, mental health issues, HIV, discrimination, substance misuse, or financial strain.

Inclusion Criteria

Parent/caregiver is primary caregiver or guardian for the participating child

Parent/caregiver is experiencing two or more major stressors of the following: trauma history, mental health difficulties, living with HIV, racial discrimination, substance misuse, and/or financial strain

My child is between 3 and 9 years old.

Exclusion Criteria

Parent or child has active suicidal or homicidal ideation

Parent or child has a significant cognitive disability, developmental delay, or pervasive developmental disorder

Parent or child has psychotic symptoms (active hallucinations, delusions, or impaired thought processes)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-session parent-based prevention program based on Family Life Skills Triple P

16-18 weeks

12 sessions (in-person or virtual)

Follow-up

Participants are monitored for social-emotional and lifestyle behavior health outcomes

12 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Family Life Skills Triple P

Trial Overview The study tests a parent-based program called Family Life Skills Triple P aimed at improving kids' social-emotional well-being and healthy behaviors. It focuses on families under significant stress to see if the program is practical and effective in these settings.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants in the intervention arm will receive a 12-session parent-based prevention program based on Family Life Skills Triple P.

Group II: Waitlist Control Active Control 1 Intervention

Participants in the waitlist control arm will not receive any intervention during the clinical trial. They will be placed on a waitlist and then offered the intervention once post assessments are complete.

Family Life Skills Triple P is already approved in United Kingdom, United States for the following indications:

Approved in United Kingdom as Triple P for:

• Prevention of neglect
• Improvement of emotional and behavioral outcomes in children

Approved in United States as Triple P for:

• Promotion of social-emotional and lifestyle behavior health among children in stressed families

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Published Research Related to This Trial

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]

The Triple P-Positive Parenting Program has been shown to produce small to moderate positive changes in parenting skills, child behavior, and parental well-being across 55 studies, indicating its effectiveness as an intervention.

The program's effectiveness is enhanced in more intensive formats and among families that are initially more distressed, with parent-reported outcomes showing larger improvements compared to observational measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive meta-analysis of Triple P-Positive Parenting Program using hierarchical linear modeling: effectiveness and moderating variables. Nowak, C., Heinrichs, N.[2022]

The Triple P-Positive Parenting Program is designed as a public health approach to improve parenting skills, aiming to enhance children's mental health and family relationships on a large scale.

This program combines universal and targeted interventions to effectively reach a broader population, particularly benefiting high-risk families and reducing behavioral and emotional issues in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correction to sanders (2008). [2015]

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-Positive Parenting Program is designed to improve the mental health and well-being of children by enhancing parents' knowledge and skills, aiming for a broad societal impact rather than just individual clinical outcomes.

This program combines universal and targeted interventions, making it effective for both general and high-risk populations, and emphasizes self-regulation as a key concept in its implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triple P-Positive Parenting Program as a public health approach to strengthening parenting. Sanders, MR.[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 Triple P-Positive Parenting Program significantly improved parenting skills and reduced parenting stress among Swiss mothers, as evidenced by lower rates of child misbehavior compared to control groups, over a 1-year period with 150 couples involved.

While the program was effective for mothers, the benefits for fathers were less pronounced, indicating a potential area for further exploration in future parenting interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of the Triple P-Positive Parenting Program in improving parenting and child behavior: a comparison with two other treatment conditions. Bodenmann, G., Cina, A., Ledermann, T., et al.[2022]

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. sciencedirect.com sciencedirect.com/science/article/pii/S000578942300120X

An Open Feasibility Trial of Family Life Skills Triple P Findings show moderate to large intra-group effect sizes for changes in child behavior problems, parenting practices and risk of child maltreatment, and medium ...

3. researchgate.net researchgate.net/publication/5376571_Effectiveness_of_The_Triple_P_Positive_Parenting_Program_on_Behavioral_Problems_in_Children_A_Meta-Analysis

Effectiveness of The Triple P Positive Parenting Program ... The aim of this meta-analysis is to assess the effectiveness of Triple P Level 4 interventions in the management of behavioral problems in ...

4. eucpn.org eucpn.org/sites/default/files/document/files/GP_DE_TripleP.pdf

Triple P-Positive Parenting Program A wide range of child parent and family outcomes were assessed including: (1) Parent reports of child social, emotional and behavioural outcomes; (2) Parenting ...

5. triplep.net triplep.net/glo-en/the-triple-p-system-at-work/evidence-based/key-research-findings/

Key research findings Research shows the Triple P parenting program improves child behaviour and reduces rates of child abuse injuries, foster care placements and parent stress.

6. 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.