Clinical trial NCT02121431: Child and Family Outcomes and Consumer Satisfaction for Online vs Staff-Delivered Parenting Intervention
Official title: Online vs Staff Delivery: Child & Family Outcomes, Value Analysis, Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Disruptive Behavior Disorders
Oppositional Defiant Disorder
Conduct Disorder
Attention Deficit Hyperactivity Disorder
Parent-Child Interactions
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Oregon Research Institute
name: University of Georgia
name: The University of Queensland
First posted: 2014-04-23
Enrollment: 334
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial addresses a serious and all-too-frequent public health problem, namely early-onset disruptive behavior problems in young children. The focus is on testing an online treatment program which empowers parents to help their children to improve their mental health and behavioral functioning. At the conclusion of the study, the investigators will know whether the online-delivered program works as well as an established staff-delivered program, with respect to child disruptive behavior problems, parenting, parent/family stress, consumer satisfaction, and value analysis.

Detailed description: High-prevalence mental health problems require innovative strategies to broaden reach of evidence-based services. Disruptive behavior problems (DBPs), or conduct problems, in young children represent a major public health challenge that is not only highly prevalent but also, left untreated, heighten risk for adverse mental health and developmental outcomes in adolescence and adulthood. Internet and online technology has considerable potential to help achieve such a goal. Building on parenting interventions that have demonstrated impact on childhood DBPs, this clinical trial compares an online-delivered intervention to a well-validated staff-delivered intervention, holding program content constant. Both interventions are based on the Triple P-Positive Parenting Program. The sample includes families with a 3-7 year old child who has a pronounced level of DBPs. The study makes use of a non-inferiority trial design to determine whether the online-delivered intervention yields as good outcomes as the well-established staff-delivered intervention with respect to childhood DBPs, parenting, and parent/family stress. The study also includes a value analysis comparing the two interventions, accounting for provider and participant expenses as well as pre-implementation and implementation phases. This study is intended to shed light on the impact and potential benefits of a viable online parenting intervention for childhood disruptive behavior problems, but the results from this study are also intended to help the mental health field to better understand more broadly the potential advantages and disadvantages of online interventions over traditionally delivered interventions, particularly in light of expense minimization/effectiveness analysis.

Eligibility criteria: Inclusion Criteria:

* clinically elevated level of child disruptive behavior problems
* parent resides with the child and has primary custody
* parent has access to internet via computer, e-tablet, or smartphone

Exclusion Criteria:

* already in a family-based treatment
* child has pervasive developmental disorder
* parent under 20 years of age
* parent has serious mental illness

Primary outcomes:
measure: childhood disruptive behavior problems
timeFrame: up to 12 months
Secondary outcomes:
measure: parenting behavior
timeFrame: baseline, 4 months (T2), 12 months (T3)
measure: parent and family stress
timeFrame: baseline, 4 months (T2), 12 months (T3)
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
city: Columbia
country: United States
facility: Parenting & Family Research Center, University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Ronald J Prinz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingels JB, Corso PS, Prinz RJ, Metzler CW, Sanders MR. Online-Delivered Over Staff-Delivered Parenting Intervention for Young Children With Disruptive Behavior Problems: Cost-Minimization Analysis. JMIR Pediatr Parent. 2022 Mar 11;5(1):e30795. doi: 10.2196/30795.
citation: Prinz RJ, Metzler CW, Sanders MR, Rusby JC, Cai C. Online-delivered parenting intervention for young children with disruptive behavior problems: a noninferiority trial focused on child and parent outcomes. J Child Psychol Psychiatry. 2022 Feb;63(2):199-209. doi: 10.1111/jcpp.13426. Epub 2021 Apr 8.