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NCT02723916

Parent Training in Pediatric Care: A Self Directed Tablet-Based Approach

Completed NA Results posted Last updated 31 December 2020
What this trial tests

NA trial testing ezParent Program in Parent Training in 287 participants. Completed in 30 June 2019.

Timeline
1 September 2015
Primary endpoint
30 June 2019
30 June 2019

Quick facts

Lead sponsorRush University Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment287
Start date1 September 2015
Primary completion30 June 2019
Estimated completion30 June 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rush University Medical Center

Who can join

18 and older, any sex, with Parent Training or Primary Care. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Parenting Behaviors Primary · T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

Measured by the Parent Questionnaire (PQ) Scale scores reported: Warmth (scale range 1-5) - higher score indicates improvement Parent Follow Through (scale range 1-5) - higher score indicates improvement Corporal punishment (scale range 1-5) - lower score indicates improvement

Parental Warmth (T1)
GroupValue95% CI
Intervention: ezParent Program4.30± 0.46
Control: Health-e Kids App4.27± 0.41
Parental Warmth (T2)
GroupValue95% CI
Intervention: ezParent Program4.26± 0.42
Control: Health-e Kids App4.25± .41
Parental Warmth (T3)
GroupValue95% CI
Intervention: ezParent Program4.29± .39
Control: Health-e Kids App4.3± .44
Parental Warmth (T4)
GroupValue95% CI
Intervention: ezParent Program4.27± .46
Control: Health-e Kids App4.34± .4
Parental Follow Through (T1)
GroupValue95% CI
Intervention: ezParent Program3.46± 0.68
Control: Health-e Kids App3.37± 0.78
Parental Follow Through (T2)
GroupValue95% CI
Intervention: ezParent Program3.47± 0.75
Control: Health-e Kids App3.49± .71
Parental Follow Through (T3)
GroupValue95% CI
Intervention: ezParent Program3.58± .77
Control: Health-e Kids App3.52± .7
Parental Follow Through (T4)
GroupValue95% CI
Intervention: ezParent Program3.64± .75
Control: Health-e Kids App3.59± .76
Change in Parent Behaviors Secondary · T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

Measured by the Parenting Young Children (PARYC) Reporting scales (scale range 1-7) (higher scores indicate more effective/improved parenting) Supporting good behavior Setting limits Proactive parenting

Supporting Good Behavior (T1)
GroupValue95% CI
Intervention: ezParent Program5.63± 0.96
Control: Health-e Kids App5.70± 0.98
Supporting Good Behavior (T2)
GroupValue95% CI
Intervention: ezParent Program5.36± 1.11
Control: Health-e Kids App5.65± 1.00
Supporting Good Behavior (T3)
GroupValue95% CI
Intervention: ezParent Program5.54± .99
Control: Health-e Kids App5.7± 1.07
Supporting Good Behavior (T4)
GroupValue95% CI
Intervention: ezParent Program5.53± 1.15
Control: Health-e Kids App5.85± .87
Setting Limits (T1)
GroupValue95% CI
Intervention: ezParent Program5.17± 1.18
Control: Health-e Kids App5.24± 1.04
Setting Limits (T2)
GroupValue95% CI
Intervention: ezParent Program5.14± 1.10
Control: Health-e Kids App5.23± 1.06
Setting Limits (T3)
GroupValue95% CI
Intervention: ezParent Program5.31± 1.07
Control: Health-e Kids App5.37± 1.19
Setting Limits (T4)
GroupValue95% CI
Intervention: ezParent Program5.41± 1.10
Control: Health-e Kids App5.52± 1.12
Change in Child Behavior Problems Secondary · T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

Strengths and Difficulties Questionnaire (SDQ) scales (range 0-10) Emotional symptoms (higher scores indicate more difficulties) Conduct problems (higher scores indicate more difficulties) Hyperactivity/inattention (higher scores indicate more difficulties) Peer relationship problems (higher scores indicate more difficulties) Prosocial behavior (higher scores indicate more strengths)

Emotion (T1)
GroupValue95% CI
Intervention: ezParent Program1.06± 1.39
Control: Health-e Kids App1.12± 1.33
Emotion (T2)
GroupValue95% CI
Intervention: ezParent Program1.1± 1.61
Control: Health-e Kids App1.03± 1.21
Emotion (T3)
GroupValue95% CI
Intervention: ezParent Program1.02± 1.43
Control: Health-e Kids App.97± 1.36
Emotion (T4)
GroupValue95% CI
Intervention: ezParent Program1.03± 1.44
Control: Health-e Kids App.92± 1.23
Conduct (T1)
GroupValue95% CI
Intervention: ezParent Program1.93± 1.90
Control: Health-e Kids App1.94± 1.77
Conduct (T2)
GroupValue95% CI
Intervention: ezParent Program1.63± 1.79
Control: Health-e Kids App1.77± 1.64
Conduct (T3)
GroupValue95% CI
Intervention: ezParent Program1.56± 1.83
Control: Health-e Kids App1.75± 1.76
Conduct (T4)
GroupValue95% CI
Intervention: ezParent Program1.4± 1.81
Control: Health-e Kids App1.53± 1.52
Change in Child Externalizing Behavior Problems Secondary · T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

Eyberg Child Behavior Inventory (ECBI) Problem scale (range 0-1) higher scores more problems Intensity scale (range 1-7) higher scores more intense problems

Problem Scale (T1)
GroupValue95% CI
Intervention: ezParent Program0.18± 0.22
Control: Health-e Kids App0.19± 0.21
Problem Scale (T2)
GroupValue95% CI
Intervention: ezParent Program.14± .18
Control: Health-e Kids App.16± .19
Problem Scale (T3)
GroupValue95% CI
Intervention: ezParent Program.14± .2
Control: Health-e Kids App.15± .19
Problem Scale (T4)
GroupValue95% CI
Intervention: ezParent Program.12± .18
Control: Health-e Kids App.13± .19
Intensity Scale (T1)
GroupValue95% CI
Intervention: ezParent Program2.80± 0.84
Control: Health-e Kids App2.84± 0.80
Intensity Scale (T2)
GroupValue95% CI
Intervention: ezParent Program2.69± .85
Control: Health-e Kids App2.69± .72
Intensity Scale (T3)
GroupValue95% CI
Intervention: ezParent Program2.64± .8
Control: Health-e Kids App2.67± .75
Intensity Scale (T4)
GroupValue95% CI
Intervention: ezParent Program2.64± .74
Control: Health-e Kids App2.56± .74
Change in Parenting Stress Secondary · T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

Parenting Stress Index-Short Form (PSI-SF) Scales (range 12-60): Higher scores indicate higher stress Parental distress Parent-child dysfunctional interaction Difficult child

Parent Domain (T1)
GroupValue95% CI
Intervention: ezParent Program26.06± 9.58
Control: Health-e Kids App25.53± 7.86
Parent Domain (T2)
GroupValue95% CI
Intervention: ezParent Program25.9± 9.26
Control: Health-e Kids App25.25± 8.17
Parent Domain (T3)
GroupValue95% CI
Intervention: ezParent Program25.39± 10.04
Control: Health-e Kids App25.41± 9.56
Parent Domain (T4)
GroupValue95% CI
Intervention: ezParent Program25.3± 9.72
Control: Health-e Kids App24.64± 8.18
Parent-Child Domain (T1)
GroupValue95% CI
Intervention: ezParent Program20.28± 6.38
Control: Health-e Kids App19.76± 6.05
Parent-Child Domain (T2)
GroupValue95% CI
Intervention: ezParent Program19.62± 6.5
Control: Health-e Kids App20.02± 5.79
Parent-Child Domain (T3)
GroupValue95% CI
Intervention: ezParent Program19.62± 6.53
Control: Health-e Kids App19.7± 6.87
Parent-Child Domain (T4)
GroupValue95% CI
Intervention: ezParent Program19.52± 6.03
Control: Health-e Kids App19.62± 6.07
Change in Parenting Self-efficacy Secondary · T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

Parenting Sense of Competence Scale (PSOC) - Total Scale (Range 17-102) Higher scores indicate higher self efficacy

Total Score (T1)
GroupValue95% CI
Intervention: ezParent Program71.07± 11.41
Control: Health-e Kids App71.28± 10.62
Total Score (T2)
GroupValue95% CI
Intervention: ezParent Program71.51± 11.20
Control: Health-e Kids App70.94± 10.7
Total Score (T3)
GroupValue95% CI
Intervention: ezParent Program72.99± 11.16
Control: Health-e Kids App71.73± 12.24
Total Score (T4)
GroupValue95% CI
Intervention: ezParent Program72.9± 12.10
Control: Health-e Kids App72.1± 11.00

Sponsor's own description

High quality and effective parenting in the preschool years is connected with long term positive child behavior and mental health outcomes. The purpose of the study, "Parent Training in Pediatric Primary Care: A Self-directed Tablet-based Approach," is to test the outcomes and implementation of a tablet-based parent training program in Pediatric Primary Care. Testing and evaluating the implementation of digitally delivered programs is important to increase the ease, reach, sustainability, and integration of mental health prevention into primary care settings.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Randomized Trial of Digitally Delivered, Self-Administered Parent Training in Primary Care: Effects on Parenting and Child Behavior.
    Breitenstein SM, Fehrenbacher C, Holod AF, Schoeny ME. · · 2021 · cited 20× · PMID 33338496 · DOI 10.1016/j.jpeds.2020.12.016
  2. Implementation findings from an effectiveness-implementation trial of tablet-based parent training in pediatric primary care.
    Breitenstein SM, Laurent S, Pabalan L, Risser HJ, et al · · 2019 · cited 10× · PMID 31621349 · DOI 10.1037/fsh0000447
  3. A study protocol testing the implementation, efficacy, and cost effectiveness of the ezParent program in pediatric primary care.
    Breitenstein SM, Schoeny M, Risser H, Johnson T. · · 2016 · cited 8× · PMID 27592122 · DOI 10.1016/j.cct.2016.08.017
  4. Referral to Digital Parent Training in Primary Care: Facilitators and Barriers.
    Fehrenbacher C, Schoeny ME, Reed M, Shattell M, et al · · 2020 · cited 4× · PMID 35821979 · DOI 10.1037/cpp0000367

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing