An interventional study of BPT-M and BPT-E in Development Delay and Behavior Problem, sponsored by University of Oregon. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by University of Oregon · Not applicable, Interventional, and Treatment
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.
Behavior problems are a common and concerning challenge among children with developmental delay (DD). Approximately 50% of children with DD have a comorbid mental disorder or serious behavior problems- a prevalence three times as high as that found in typically developing youths. Behavioral parent training (BPT) is the gold-standard intervention for treating child behavior problems in typically developing children and in children with DD. However, high levels of parental stress are associated with reduced or no response to BPT for children with DD. Consequently, parental stress may attenuate the efficacy of the gold-standard, empirically supported treatment for behavior problems among children with DD. As such, parental stress is a critical point of intervention for improving both parent and child outcomes in families of children with DD. The purpose of this study is to quantify the therapeutic benefit of adding a parent stress-reduction intervention prior to delivering BPT in order to more effectively reduce child behavior problems, and to investigate the mechanisms through which intervention outcomes occur.
517 studies on the registry are indexed under Problem Behavior; 92 are open to participants now.
This study's enrollment of 959 is above the median of 90 across 391 interventional studies indexed under Problem Behavior.
Browse Problem Behavior studies →University of Oregon is the lead sponsor of 75 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: BPT-E
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.
Behavioral: BPT-M
At each wave of data collection, caregivers in both conditions were asked to identify a teacher who could provide an evaluation of their child's behavior outside the home. Participating teachers completed a brief 2-page questionnaire about the child.
Participants randomized to the BPT-M condition receive the Mindfulness-Based Stress Reduction (MBSR) intervention, followed by Behavioral Parent Training (BPT). The MBSR module includes six weekly 2.5 hour group sessions, 30-45 minutes of daily home practice guided by audio CDs, and an MBSR parent workbook. In the sessions, participants practice formal mindfulness exercises, and are provided instruction on stress physiology and using mindfulness for coping with stress in everyday life. The BPT component of the intervention includes 10 weekly sessions lasting 2.5 hours. Each session is structured around videotape vignettes and uses discussion, role-playing, modeling, and feedback to foster mastery of the material. Parents are given weekly homework assignments and practice their skills.
Participants randomized to the BPT-E condition will received 6 weeks of a psychoeducation program followed by 10 weeks of the Behavioral Parent Training (BPT) used in both conditions. The psychoeducation module consists of 6 weekly 2.5-hour sessions, daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations. Each of the 6 weekly sessions includes a general topic for discussion. These include preparing for IEP meetings, navigating the regional center and developmental service agencies, communicating with teachers, advocacy, sibling issues, and community resources.
Change From Baseline in Child Behavior Problems (Parent Report)
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.
Time frame: baseline, immediately after 16-week intervention, 6 months, 12 months
Change From Baseline in Parenting Behavior (Parent Report)
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.
Time frame: baseline, immediately after 16-week intervention, 6 months, 12 months
Change From Baseline in Parenting Stress (Parent Self-Report)
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.
Time frame: baseline, immediately after 16-week intervention, 6 months, 12 months
| Milestone | BPT-E | BPT-M | Teachers |
|---|---|---|---|
| Started | 261 | 260 | 438 |
| Received intervention as assigned | 107 | 114 | 0 |
| Completed follow-up immediately after intervention | 186 | 192 | 0 |
| Completed 6-month follow-up | 183 | 187 | 0 |
| Completed 12-month follow-up | 194 | 201 | 0 |
| Completed | 215 | 219 | 438 |
| Not completed | 46 | 41 | 0 |
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.
| score on a scale | BPT-E | BPT-M |
|---|---|---|
| Baseline | 73.60 ± 27.77 | 77.95 ± 26.99 |
| Immediately after 16-week intervention | 71.49 ± 29.51 | 71.69 ± 30.40 |
| 6-month follow-up | 67.85 ± 29.51 | 70.67 ± 33.17 |
| 12-month follow-up | 66.48 ± 29.43 | 68.25 ± 31.39 |
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.
| score on a scale | BPT-E | BPT-M |
|---|---|---|
| Baseline | 3.85 ± 1.21 | 3.90 ± 1.03 |
| Immediately after 16-week intervention | 4.02 ± 0.92 | 4.12 ± 1.02 |
| 6-month follow-up | 4.10 ± 1.04 | 4.13 ± 1.06 |
| 12-month follow-up | 4.15 ± 0.94 | 4.10 ± 0.99 |
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.
| score on a scale | BPT-E | BPT-M |
|---|---|---|
| Baseline | 113.70 ± 20.01 | 115.28 ± 20.86 |
| Immediately After 16-week Intervention | 101.23 ± 21.73 | 100.10 ± 20.80 |
| 6-month Follow-up | 97.72 ± 25.08 | 96.89 ± 22.33 |
| 12-month Follow-up | 96.21 ± 20.73 | 94.93 ± 26.40 |
Collected over Caregivers and children were monitored for adverse events over the study period (e.g., up to 24 months from baseline).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BPT-E | 0/261 (0%) | 0/261 (0%) | 0/261 (0%) |
| BPT-M | 0/260 (0%) | 0/260 (0%) | 0/260 (0%) |
| Teachers | — | — | — |
At baseline,131 caregivers in each condition provided data for themselves and their children, and 128 children in each condition participated in observation/ play tasks. Three additional children engaged in play tasks at later waves and are included here as having "started" the study. The current teacher of each child was recruited at each wave, resulting in a total of 438 teachers providing data about students at some point during the study. 170 teachers completed surveys at baseline.
| Age, Continuous(years) | BPT-E | BPT-M | Teachers | Total |
|---|---|---|---|---|
| Caregivers | 37.31 ± 7.65 | 37.32 ± 7.64 | — | 37.31 ± 7.63 |
| Children | 4.28 ± 0.85 | 4.32 ± .88 | — | 4.30 ± .86 |
| Age, Customized(Participants) | BPT-E | BPT-M | Teachers | Total |
|---|---|---|---|---|
| 18-25 years | — | — | 29 | 29 |
| 26-35 years | — | — | 89 | 89 |
| 36-45 years | — | — | 65 | 65 |
| 46-55 years | — | — | 58 | 58 |
| 56-65 years | — | — | 29 | 29 |
| 66 years and older | — | — | 2 | 2 |
| prefer not to answer | — | — | 2 | 2 |
| Sex: Female, Male(Participants) | BPT-E | BPT-M | Teachers | Total |
|---|---|---|---|---|
| Caregivers — Female | 128 | 124 | — | 252 |
| Caregivers — Male | 3 | 7 | — | 10 |
| Children — Female | 51 | 40 | — | 91 |
| Children — Male | 79 | 89 | — | 168 |
| Teachers — Female | — | — | 258 | 258 |
| Teachers — Male | — | — | 16 | 16 |
| Ethnicity (NIH/OMB)(Participants) | BPT-E | BPT-M | Teachers | Total |
|---|---|---|---|---|
| Caregivers — Hispanic or Latino | 80 | 72 | — | 152 |
| Caregivers — Not Hispanic or Latino | 45 | 57 | — | 102 |
| Caregivers — Unknown or Not Reported | 6 | 2 | — | 8 |
| Children — Hispanic or Latino | 87 | 83 | — | 170 |
| Children — Not Hispanic or Latino | 38 | 44 | — | 82 |
| Children — Unknown or Not Reported | 5 | 2 | — | 7 |
| Teachers — Hispanic or Latino | — | — | 96 | 96 |
| Teachers — Not Hispanic or Latino | — | — | 178 | 178 |
| Teachers — Unknown or Not Reported | — | — | 0 | 0 |
| Race (NIH/OMB)(Participants) | BPT-E | BPT-M | Teachers | Total |
|---|---|---|---|---|
| Caregivers — American Indian or Alaska Native | 0 | 0 | — | 0 |
| Caregivers — Asian | 5 | 2 | — | 7 |
| Caregivers — Native Hawaiian or Other Pacific Islander | 0 | 0 | — | 0 |
| Caregivers — Black or African American | 8 | 9 | — | 17 |
| Caregivers — White | 25 | 34 | — | 59 |
| Caregivers — More than one race | 7 | 12 | — | 19 |
| Caregivers — Unknown or Not Reported | 86 | 74 | — | 160 |
| Children — American Indian or Alaska Native | 1 | 1 | — | 2 |
| Children — Asian | 3 | 2 | — | 5 |
| Children — Native Hawaiian or Other Pacific Islander | 0 | 0 | — | 0 |
| Children — Black or African American | 7 | 12 | — | 19 |
| Children — White | 32 | 41 | — | 73 |
| Children — More than one race | 10 | 4 | — | 14 |
| Children — Unknown or Not Reported | 77 | 69 | — | 146 |
| Teachers — American Indian or Alaska Native | 0 | 0 | 2 | 2 |
| Teachers — Asian | 0 | 0 | 24 | 24 |
| Teachers — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Teachers — Black or African American | 0 | 0 | 16 | 16 |
| Teachers — White | 0 | 0 | 122 | 122 |
| Teachers — More than one race | 0 | 0 | 15 | 15 |
| Teachers — Unknown or Not Reported | 0 | 0 | 95 | 95 |
| Region of Enrollment(participants) | BPT-E | BPT-M | Teachers | Total |
|---|---|---|---|---|
| United States | 261 | 260 | 438 | 959 |
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University of Oregon