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BPT-M for Developmental Delay

N/A
Waitlist Available
Led By Laura L McIntyre, PhD
Research Sponsored by University of Oregon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after 16 week intervention
Awards & highlights

Study Summary

This trial is testing whether two different types of interventions (parenting stress reduction and parent management strategies) are more effective than one in reducing behavior problems among children with developmental delay.

Eligible Conditions
  • Developmental Delay
  • Behavioral Problem

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after 16 week intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after 16 week intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to 12-month follow-up in child behavior problems, assessed using multiple reporters, including parents and teachers, as well as observer ratings.
Change from baseline to 6-month follow-up in child behavior problems, assessed using multiple reporters, including parents and teachers, as well as observer ratings.
Change from baseline to post-treatment in child behavior problems, assessed using multiple reporters, including parents and teachers, as well as observer ratings.
Secondary outcome measures
Change from baseline to 12-month follow-up in parenting behavior, assessed by parent self-report and and observer ratings.
Change from baseline to 12-month follow-up in parenting stress, assessed by parent self-report.
Change from baseline to 6-month follow-up in parenting behavior, assessed by parent self-report and and observer ratings.
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: BPT-MExperimental Treatment1 Intervention
Behavioral parent training (BPT) plus mindfulness-based stress reduction (MBSR). Includes a 10-week standard BPT, plus a 6-week MBSR delivered prior to the standard BPT.
Group II: BPT-EExperimental Treatment1 Intervention
Behavioral parent training (BPT) plus a psychoeducation program. Includes a 10-week standard BPT, plus a 6-week psychoeducation program delivered prior to the standard BPT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BPT-M
2018
N/A
~220
BPT-E
2018
N/A
~220

Find a Location

Who is running the clinical trial?

Loma Linda UniversityOTHER
304 Previous Clinical Trials
259,276 Total Patients Enrolled
University of OregonLead Sponsor
80 Previous Clinical Trials
46,547 Total Patients Enrolled
Laura L McIntyre, PhDPrincipal InvestigatorUniversity of Oregon

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still possible for those interested in participating in this trial?

"As per the information on clinicaltrials.gov, recruitment for this trial has stopped since its last update in April 2022. Initially posted as early as September 2018, over a hundred other trials are currently welcoming applicants."

Answered by AI

What ultimate goals are investigators attempting to attain through this research?

"This 16-week medical study seeks to assess the impact of an intervention on child behaviour problems, parenting stress and parental behaviour. Multiple reporters will measure these outcomes including parents, teachers, as well as observer ratings. To evaluate levels of parenting stress, parent self report mechanisms such as the Parenting Stress Index Fourth Edition Short Form (PSI4-SF), Family Impact Questionnaire's Negative Impact Scale and Parenting Daily Hassles Intensity subscale are applied to build a "parenting stress" construct. For assessing changes in parenting behavior, sources like theParenting Practices Inventory and Phaneuf & McIntyre observation systems are used to form"

Answered by AI
~33 spots leftby Mar 2025