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NCT03599648

The Pro-Parenting Study: Helping Parents Reduce Behavior Problems in Preschool Children With Developmental Delay

Completed NA Results posted Last updated 11 March 2025
What this trial tests

NA trial testing BPT-M in Development Delay in 959 participants. Completed in 18 July 2023.

Timeline
14 September 2018
Primary endpoint
18 July 2023
18 July 2023

Quick facts

Lead sponsorUniversity of Oregon
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment959
Start date14 September 2018
Primary completion18 July 2023
Estimated completion18 July 2023
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Oregon

Who can join

18 and older, any sex, with Development Delay or Behavior Problem. 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.

Change From Baseline in Child Behavior Problems (Parent Report) Primary · baseline, immediately after 16-week intervention, 6 months, 12 months

Parents report on child behavior using the Child Behavior Checklist-Ages 1.5-5 years (Achenbach, 2000), a 99-item questionnaire that assesses behavioral problems in young children. Parents were asked to rate how accurately each item described their child's behavior over the past 2 months using a 3-pt scale (0=not true/ 1= somewhat or sometimes true/ 2= very true or often true). A Total Behavior Problems score was derived by taking the sum of all 99 items, with a possible range of 0-198. A high score indicates greater problem behavior.

Baseline
GroupValue95% CI
BPT-E73.60± 27.77
BPT-M77.95± 26.99
Immediately after 16-week intervention
GroupValue95% CI
BPT-E71.49± 29.51
BPT-M71.69± 30.40
6-month follow-up
GroupValue95% CI
BPT-E67.85± 29.51
BPT-M70.67± 33.17
12-month follow-up
GroupValue95% CI
BPT-E66.48± 29.43
BPT-M68.25± 31.39
Change From Baseline in Parenting Behavior (Parent Report) Secondary · baseline, immediately after 16-week intervention, 6 months, 12 months

Parents report on their parenting behavior using the Parenting Practices Interview (The Incredible Years, 2015), a 73-item questionnaire with 7 summary scales. Parents were asked how often they engaged in various parenting practices when their child misbehaved, or their likelihood of responding with a certain parenting behavior in provided scenarios of negative child behavior. The Appropriate Discipline summary scale (12 items) was used in the present study. Scores ranged from 1 to 7. Higher scores indicate greater use of appropriate disciplinary practices.

Baseline
GroupValue95% CI
BPT-E3.85± 1.21
BPT-M3.90± 1.03
Immediately after 16-week intervention
GroupValue95% CI
BPT-E4.02± 0.92
BPT-M4.12± 1.02
6-month follow-up
GroupValue95% CI
BPT-E4.10± 1.04
BPT-M4.13± 1.06
12-month follow-up
GroupValue95% CI
BPT-E4.15± 0.94
BPT-M4.10± 0.99
Change From Baseline in Parenting Stress (Parent Self-Report) Secondary · baseline, immediately after 16-week intervention, 6 months, 12 months

Parents report on their parenting stress using the Parenting Stress Index-Fourth Edition, Short Form (PSI4-SF; Abidin, 1995). Parents were asked to indicate their agreement with 36 statements about their feelings on a 5 pt scale (strongly agree, agree, not sure, disagree, strongly disagree). A Total Stress Score was derived from responses to these items, and scores could range from 36-180. High scores indicate greater parenting stress.

Baseline
GroupValue95% CI
BPT-E113.70± 20.01
BPT-M115.28± 20.86
Immediately After 16-week Intervention
GroupValue95% CI
BPT-E101.23± 21.73
BPT-M100.10± 20.80
6-month Follow-up
GroupValue95% CI
BPT-E97.72± 25.08
BPT-M96.89± 22.33
12-month Follow-up
GroupValue95% CI
BPT-E96.21± 20.73
BPT-M94.93± 26.40

Sponsor's own description

The Pro-Parenting Study seeks to determine the added benefit of targeting both parenting stress and parent management strategies to more effectively reduce behavior problems among children with developmental delay (DD). Findings from this study will improve the scientific understanding of evidence-based interventions for behavior problems among children with DD and the mechanisms underlying therapeutic change.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Mindfulness-enhanced parenting programmes for improving the psychosocial outcomes of children (0 to 18 years) and their parents.
    Featherston R, Barlow J, Song Y, Haysom Z, et al · · 2024 · cited 5× · PMID 38197473 · DOI 10.1002/14651858.cd012445.pub2

Verify or expand the search:

Other recruiting trials for Development Delay

Currently open trials in the same condition.

Other University of Oregon trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03599648.

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