SBIR/ STTR Family Check-up Online
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Oregon
About this trial
The Family Check-Up Online, a digital health intervention, was designed to improve child mental health through family-centered intervention. The Family Check-Up is grounded in over 25 years of evidence-based research and has been shown to improve child mental health and behavior including depression and conduct problems. The investigators were supported by an SBIR Phase I award (R43MH132191) to evaluate the feasibility and acceptability of the digital health product in schools and to adapt the product based on findings of that work. Findings from that project suggested the model is a good fit for schools, with school providers stating a need for family-centered interventions that target child behavior and mental health, but with few resources or evidence-based programs available. The research team received feedback that suggests the model should be evaluated as both an uncoached version and coached version, delivered with provider support. In the current project, the investigators plan to continue work in schools to develop the model for commercialization, including understanding the process for embedding the FCU Online into current student support systems and implementation factors that lead to maintenance of the model in schools. The investigators plan to conduct a hybrid type 2 effectiveness-implementation trial to evaluate the effectiveness of the FCU Online when delivered by real world providers. Thirty providers (N=600 students/families) will be randomly assigned to receive training in the FCU Online coached vs. uncoached models. The research team will then evaluate outcomes including family relationships, parenting skills, and child mental health and behavior. The investigators predict that the FCU Online will improve child mental health and behavior, and will test for moderators such as provider training and child baseline risk. Findings will have implications for commercialization of the product in schools and implementation of the model in a range of different school settings.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
A caregiver must have a child between the ages of 11 and 14 enrolled at a participating school;
the caregiver must be the parent or legal guardian of the youth;
the caregiver must have a smartphone with text messaging capability and access to email; and
the youth must be identified by school providers as needing or being eligible for Tier 2 or Tier 3 supports or services.
Disqualifiers
the caregiver is unable to read in either English or Spanish; or
the family is already participating in another study of the University of Oregon's Prevention Science Institute.
Trial design
Design model
Parallel
Treatments tested in this trial
Family Check-Up Online
BehavioralThe Family Check-Up Online is a digital intervention that includes an assessment, computer-generated feedback, and intervention modules that focus on improving family relationships and parenting skills in order to reduce child mental health problems and to improve child self-regulation. These modules include Healthy Behaviors for Stressful Times, Positive Parenting, Rules and Consequences, Supporting School Success, and Communication.
FCU Online with Telehealth Coaching
BehavioralThis intervention is the Family Check-Up Online plus telehealth support from a parenting coach. The Family Check-Up Online is a digital intervention that includes an assessment, computer-generated feedback, and intervention modules that focus on improving family relationships and parenting skills in order to reduce child mental health problems and to improve child self-regulation. These modules include Healthy Behaviors for Stressful Times, Positive Parenting, Rules and Consequences, Supporting School Success, and Communication. A coach based at the child's school meets with caregivers via telehealth modality to provide motivation and to help caregivers tailor the content of the modules to their specific child and family's needs.
Treatment groups
670 Participants
are divided into 4 treatment groupsGroup A: FCU Online with telehealth coachingExperimental treatment 1 intervention
Group B: FCU OnlineExperimental treatment 1 intervention
Group C: Providers participating in feasibility/ acceptability interviewsNo intervention 0 interventions
Group D: Parents participating in feasibility/ acceptability interviewsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change from Baseline in Child Depression (Parent report)
Parents report on their child's depression using the two item PHQ-2. Scores for the individual items range from 0 (not at all) to 3 (nearly all) and are summed together. Higher scores indicate greater child depression.
Time frame
baseline, 6 months2
Change from Baseline in Child Anxiety (Parent report)
Parents report on their child's anxiety using the two item GAD-2. Scores for the individual items range from 0 (not at all) to 3 (nearly all) and are summed together. Higher scores indicate greater child anxiety.
Time frame
baseline, 6 months3
Change from Baseline in Positive Parenting (Parent report)
Parents report on their use of positive parenting skills using a modified version of the Parenting Young Children scale. Parents are asked to indicate the frequency with which they used positive parenting skills (such as encouragement and praise, relationship building, giving clear directions, and using rewards for positive behavior) over the past month using a 5-pt scale (0=Never/ 1=Rarely/ 2= Sometimes/ 3=Often/ 4=Very Often). Responses to these 10 items are summed. Higher scores indicate frequent use of positive parenting skills.
Time frame
baseline, 6 months4
Change from Baseline in Rules and Consequences (Parent report)
Parents report on the extent to which they enforced rules and consequences for negative behavior over the past month using a 13-item scale developed for this project. Parents are asked to indicate the frequency with which they monitored their child's behavior, set clear rules, applied logical consequences, and ignored annoying behavior using a 5-pt scale (0=Never/ 1=Rarely/ 2= Sometimes/ 3=Often/ 4=Very Often). Responses are summed and higher scores indicate more consistent use of rules and consequences.
Time frame
baseline, 6 monthsSponsors and contacts
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University of Oregon
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov