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
Group
Value
95% CI
BPT-E
73.60
± 27.77
BPT-M
77.95
± 26.99
Immediately after 16-week intervention
Group
Value
95% CI
BPT-E
71.49
± 29.51
BPT-M
71.69
± 30.40
6-month follow-up
Group
Value
95% CI
BPT-E
67.85
± 29.51
BPT-M
70.67
± 33.17
12-month follow-up
Group
Value
95% CI
BPT-E
66.48
± 29.43
BPT-M
68.25
± 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
Group
Value
95% CI
BPT-E
3.85
± 1.21
BPT-M
3.90
± 1.03
Immediately after 16-week intervention
Group
Value
95% CI
BPT-E
4.02
± 0.92
BPT-M
4.12
± 1.02
6-month follow-up
Group
Value
95% CI
BPT-E
4.10
± 1.04
BPT-M
4.13
± 1.06
12-month follow-up
Group
Value
95% CI
BPT-E
4.15
± 0.94
BPT-M
4.10
± 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
Group
Value
95% CI
BPT-E
113.70
± 20.01
BPT-M
115.28
± 20.86
Immediately After 16-week Intervention
Group
Value
95% CI
BPT-E
101.23
± 21.73
BPT-M
100.10
± 20.80
6-month Follow-up
Group
Value
95% CI
BPT-E
97.72
± 25.08
BPT-M
96.89
± 22.33
12-month Follow-up
Group
Value
95% CI
BPT-E
96.21
± 20.73
BPT-M
94.93
± 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):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Oregon
Last refreshed: 11 March 2025
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.