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

Trial Summary

What is the purpose of this trial?

This study evaluates feasibility and preliminary efficacy of a parent-based prevention program to promote social-emotional and lifestyle behavior health among 3- to 9-year-old children in families experiencing major stressors.

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 data supports the effectiveness of the treatment Family Life Skills Triple P, Triple P, Positive Parenting Program?

Research shows that the Triple P-Positive Parenting Program helps improve parenting skills and reduces child behavior problems. Studies found that it leads to positive changes in parenting and child behavior, with more significant improvements seen in more intensive formats and families facing more challenges. ^{1 2 3 4 5}

Is the Family Life Skills Program for Childhood Behavior safe for participants?

The Triple P-Positive Parenting Program, which is similar to the Family Life Skills Program, is generally considered safe. It focuses on improving parenting skills and confidence, and there are no reports of harm or safety concerns in the available research. ^{2 4 5 6 7}

How is the Family Life Skills Triple P treatment different from other treatments for childhood behavior problems?

The Family Life Skills Triple P treatment is unique because it is a comprehensive, multilevel parenting program that aims to improve parenting skills and confidence on a large scale, reaching more families than traditional methods. It combines universal strategies with targeted interventions for high-risk children, focusing on self-regulation and enhancing family relationships. ^{2 4 6 7 8}

Research Team

Nada M Goodrum, Ph.D.

Principal Investigator

University of South Carolina

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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]

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

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

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

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

3. England 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. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

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

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

Triple P-Positive Parenting Program as a public health approach to strengthening parenting. [2022]

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

Correction to sanders (2008). [2015]

8. 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]