Development DelayNCT03599648
The Pro-Parenting Study: Helping Parents Reduce Behavior Problems in Preschool Children With Developmental Delay
A study testing BPT-M and BPT-E in people with Development Delay and Behavior Problem, run by University of Oregon at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Development Delay, Behavior Problem
- What is being tested?
- BPT-M and BPT-E
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 959 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Sep 2018to 18 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent has a child ages 3 to 5 years with an agency-identified DD in one or more functional areas who is receiving early intervention or early childhood/ preschool special education through an individualized family service plan (IFSP) or individualized education plan (IEP);
- Parent reports elevated child behavior problems, as indicated by a T-score of 60 or above on the Total Problems scale of the Child Behavior Checklist;
- Parent reports elevated parenting stress, as indexed by a total score above the recommended cutoff at the 85th percentile on the Parenting Stress Index-4.
Who cannot join
- Parent screens positive for active psychosis, substance abuse, or suicidality;
- Parent is currently receiving any form of psychological or behavioral treatment at the time of referral; or
- The child has sensory impairments or nonambulatory conditions that would necessitate the need for significant modifications to the lab and home visit protocols.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loma Linda University
Loma Linda, California, 92350
University of Oregon
Portland, Oregon, 97209
About this study
Official title: Testing the Efficacy of Mindfulness-Based Stress Reduction Combined With Behavioral Parent Training in Families With Preschoolers With Developmental Delay
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.
Read the detailed description
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.
- Conditions
- Development Delay, Behavior Problem
- Being tested
- BPT-M, BPT-E
- Keywords
- intervention, behavioral parent training, mindfulness-based stress reduction
- Medical subject headings
- Learning Disabilities, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPT-MBehavioural
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.
BPT-EBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BPT-E | Experimental | 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. Receives: Behavioral: BPT-E |
| BPT-M | Experimental | 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. Receives: Behavioral: BPT-M |
| Teachers | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, immediately after 16-week intervention, 6 months, 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: baseline, immediately after 16-week intervention, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start14 Sep 2018
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Development DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 959 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- Loma Linda University
- Responsible party
- Principal investigator, Laura Lee McIntyre, University of Oregon
- Investigators
- Laura L McIntyre, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599648
- Sponsor's protocol ID
- R01HD093667-01A1
- Status last verified
- Feb 2025
- First submitted
- 11 Jul 2018
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of Mindfulness-Based Stress Reduction Combined With Behavioral Parent Training in Families With Preschoolers With Developmental Delay
- ClinicalTrials.gov ID
- NCT03599648
- Acronym / sponsor ID
- R01HD093667-01A1
- Conditions
- Development Delay, Behavior Problem
- Keywords
- intervention, behavioral parent training, mindfulness-based stress reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 959 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- Loma Linda University
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 3 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BPT-E | Experimental | Behavioral: BPT-EBehavioral 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. |
| BPT-M | Experimental | Behavioral: BPT-MBehavioral 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. |
| Teachers | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent has a child ages 3 to 5 years with an agency-identified DD in one or more functional areas who is receiving early intervention or early childhood/ preschool special education through an individualized family service plan (IFSP) or individualized education plan (IEP);
- Parent reports elevated child behavior problems, as indicated by a T-score of 60 or above on the Total Problems scale of the Child Behavior Checklist;
- Parent reports elevated parenting stress, as indexed by a total score above the recommended cutoff at the 85th percentile on the Parenting Stress Index-4.
Key exclusion criteria (3 listed)
- Parent screens positive for active psychosis, substance abuse, or suicidality;
- Parent is currently receiving any form of psychological or behavioral treatment at the time of referral; or
- The child has sensory impairments or nonambulatory conditions that would necessitate the need for significant modifications to the lab and home visit protocols.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPT-MParticipants 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. | Behavioural | BPT-M |
| BPT-EParticipants 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. | Behavioural | BPT-E |
Primary outcome
Change From Baseline in Child Behavior Problems (Parent Report)
Time frame: 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.
2 secondary outcomes
Change From Baseline in Parenting Behavior (Parent Report)
Time frame: baseline, immediately after 16-week intervention, 6 months, 12 months
Change From Baseline in Parenting Stress (Parent Self-Report)
Time frame: baseline, immediately after 16-week intervention, 6 months, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura L McIntyre, PhD principal investigator
University of Oregon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPT-M and BPT-E in people with Development Delay and Behavior Problem, run by University of Oregon at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Child Behavior Problems (Parent Report) (time frame: baseline, immediately after 16-week intervention, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.