Evaluating an Online Parenting Support System Disseminated by Pediatric Practices

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Evaluating an Online Parenting Support System Disseminated by Pediatric Practices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064452
• Other study ID #: DA021307-06A1
• Secondary ID: 2R01DA021307-06A
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: March 2019

Study information

• Verified date: April 2019
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will experimentally evaluate an internet-based version of the Triple P Positive Parenting Program, the Triple P Online System (TPOS), which presents the Triple P content in an interactive, video-enriched, and personalized format with 3-levels of flexible dosage, and will compare it against usual community services. Thirty pediatric clinics involving 100 practitioners in 9 counties across western Washington will be recruited and randomized to receive (a) access for their patients to the Triple P Online System and training in how to effectively promote TPOS and advise parents on their children's behavior problems or (b) Usual Care Community-Waitlist Control, in which parents will be assisted with an appropriate referral for services in the community.

Description:

Disruptive behavior problems are among the most prevalent mental health conditions for young children, and they carry significant risks for later socioemotional, conduct, and academic problems, such as substance abuse, delinquency, and school failure. How parents handle these challenging behaviors strongly influences their children's long-term trajectory. Evidence-based parenting programs have shown much value in reducing early-onset disruptive behavior problems, thereby reducing risks for later substance abuse and other behavioral health problems. The reach of parenting programs is limited, however, by significant challenges in recruiting, engaging, and retaining parents, such that most parents who could benefit from parenting assistance never receive it. A public health approach for improving parenting practices that makes evidence-based parenting programs widely available and accessible in a range of formats could reduce the prevalence of disruptive behavior problems, and thus the population-level risk for substance abuse and other adverse outcomes. Internet-based intervention offers significant potential as part of a population-wide strategy for bringing evidence-based parenting practices to a broad range of parents experiencing challenges in raising their children. Furthermore, pediatricians could be a natural touchpoint for reaching families with evidence-based parenting supports. The field knows little, however, about the potential of the internet to strengthen parenting practices, or about how pediatric practitioners might be engaged in improving the reach of an online parenting program. This study will experimentally evaluate an internet-based version of the Triple P Positive Parenting Program, the Triple P Online System (TPOS), which presents the Triple P content in an interactive, video-enriched, and personalized format with 3-levels of flexible dosage, and will compare it against usual community services. Thirty pediatric clinics involving 100 practitioners in 9 counties across western Washington will be recruited and randomized to receive (a) access for their patients to the Triple P Online System and training in how to effectively promote TPOS and advise parents on their children's behavior problems or (b) Usual Care Community-Waitlist Control, in which parents will be assisted with an appropriate referral for services in the community. Practitioners will recruit into their respective conditions 400 families of 3-8 year-old children with elevated behavior problems. Measures of parents' parenting practices, family functioning, children's disruptive behavior problems, and practitioners' protocols for advising on behavior problems will be obtained at baseline, post-intervention, and 1-year follow-up. The efficacy of the Triple P Online System in improving these outcomes will be examined, as well as dosage-response relationships. This study will further our understanding of the potential value of promoting internet-based parenting programs through pediatric practitioners. Maximizing the reach of evidence-based parenting programs has the potential to reduce the prevalence of children's behavior problems, and thus reduce risks for later problems such as substance abuse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 2019
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• Pediatric practitioners at participating clinics in western Washington.

• Families of children 3-8 years old referred by participating pediatric practitioners. Eligible families will: (a) have a child 3-8 years old, (b) have at least half-time custody of the child, (c) care for the child at least 16 waking hours per week, (d) express concern to their practitioner about difficulties with the child's behavior, (e) score .80 standard deviation or more above the normed mean on the Eyberg Child Behavior Inventory, (f) speak English, and (g) have regular access to high-speed internet.

Exclusion Criteria:

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Child Disruptive Behavior Disorders
• Conduct Disorder
• Disease
• Mental Disorders
• Oppositional Defiant Disorder
• Problem Behavior

Intervention

Other:
• Triple P Online System
The Triple P Online System (TPOS) is an online parenting support program designed to assist parents in developing effective parenting practices for handling their children's problem behaviors. Content focuses on positive attention and praise, teaching strategies, effective discipline, antecedent strategies to avoid problems in high-risk situations, and applying these principles to specific situations. TPOS integrates 3 different levels of program intensity to meet different levels of family need, based on severity of children's behavior problems.

Behavioral:
• Placebo Comparator
Enhanced Usual Community Care-Waitlist

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon
United States	Seattle Children's Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Research Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline at T2 and T3 on Parenting and Family Adjustment Scale (Sanders & Morawska, 2010)	40-item parent-report questionnaire; assesses discipline practices, positive parenting, parent mood, family relationships, and co-parenting support at T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).	T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
Secondary	Child Adjustment and Parent Efficacy Scale (Morawska & Sanders, 2010)	Parent-report questionnaire; 30 items measure children's emotional and behavioral problems and positive behaviors; 20 items measures parents' self-efficacy for handling the problem behaviors	T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
Secondary	Knowledge of Effective Parenting Scale (Winter, Morawska, & Sanders, 2011)	Multiple-choice parenting knowledge quiz	T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
Secondary	Child and Adolescent Disruptive Behavior Inventory (Burns, Taylor, & Rusby, 2001)	Parent-report questionnaire measuring children's oppositional behavior to adults, oppositional behavior to other children, hyperactivity, and conduct problems	T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
Secondary	Parent Daily Report (adapted from Chamberlain & Reid, 1987), coded with the Parent Discipline Interview Coding System (Rusby, Metzler, Sanders & Ware, 2010)	Series of 3 phone interviews with mother at each timepoint; mother reports on frequency of specific problematic and positive child behaviors over the past 24 hours. Mother reports how she handled the two most problematic behaviors; answers are coded by independent coders.	T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
Secondary	Preschool Age Psychiatric Assessment (Egger & Angold, 2004)	Diagnostic interview, administered over the phone to mothers, used for study children ages 3-5; modules assessing Oppositional Defiant Disorder, Conduct Disorder, and Attention Deficit Hyperactivity Disorder are utilized.	T1 (Baseline), T3 (1 year after T2).
Secondary	National Institute of Mental Health Diagnostic Interview Schedule for Children Version IV (Shaffer, Fisher, Lucas, Dulcan & Schwab-Stone, 2000)	Diagnostic interview, administered over the phone to mothers, used for study children ages 6-8; modules assessing Oppositional Defiant Disorder, Conduct Disorder, and Attention Deficit Hyperactivity Disorder are utilized.	T1 (Baseline), T3 (1 year after T2).
Secondary	Pediatricians' self-efficacy for advising parents of children with conduct problems, typical referral patterns for these problems, attitudes toward evidence-based self-administered parenting interventions	pediatrician-reported questionnaire	T1 (Baseline), T2 (10 months after T1), T3 (1 year after T2).

External Links

•   Link to study website