Behavior Problem, Development Delay
Conditions
Keywords
intervention, behavioral parent training, mindfulness-based stress reduction
Brief 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). 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.
Interventions
BEHAVIORALBPT-M
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.
BEHAVIORALBPT-E
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.
Sponsors
Loma Linda University
University of Oregon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Child Behavior Problems (Parent Report) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Parenting Behavior (Parent Report) | 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. |
| Change From Baseline in Parenting Stress (Parent Self-Report) | 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. |
Countries
United States
Participant flow
Pre-assignment details
A total of 1041 families were assessed for eligibility, and 779 were excluded (591 did not meet inclusion criteria, 43 refused to participate, and 145 were excluded for other reasons such as not completing screening, geographic reasons, or scheduling challenges). In the end, 262 families (i.e., caregiver + child) were randomized and assigned to an arm. Children's current teachers were also invited to participate at each wave. A total of 660 teachers were invited; 438 completed a survey.
Participants by arm
| Arm | Count |
|---|---|
| BPT-E 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.
BPT-E: 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. | 261 |
| BPT-M 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.
BPT-M: 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. | 260 |
| Teachers Regardless of treatment condition to which parents were assigned, children's current teachers were invited to participate at each wave of data collection. Participating teachers completed a 2-page questionnaire about their participating student. Because children moved to different classrooms with different teachers throughout the study, different teachers reported on a given child at each wave. | 438 |
| Total | 959 |
Baseline characteristics
| Characteristic | BPT-E | BPT-M | Total | Teachers |
|---|---|---|---|---|
| Age, Continuous Caregivers | 37.31 years STANDARD_DEVIATION 7.65 | 37.32 years STANDARD_DEVIATION 7.64 | 37.31 years STANDARD_DEVIATION 7.63 | — |
| Age, Continuous Children | 4.28 years STANDARD_DEVIATION 0.85 | 4.32 years STANDARD_DEVIATION 0.88 | 4.30 years STANDARD_DEVIATION 0.86 | — |
| Age, Customized 18-25 years | — | — | 29 Participants | 29 Participants |
| Age, Customized 26-35 years | — | — | 89 Participants | 89 Participants |
| Age, Customized 36-45 years | — | — | 65 Participants | 65 Participants |
| Age, Customized 46-55 years | — | — | 58 Participants | 58 Participants |
| Age, Customized 56-65 years | — | — | 29 Participants | 29 Participants |
| Age, Customized 66 years and older | — | — | 2 Participants | 2 Participants |
| Age, Customized prefer not to answer | — | — | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 80 Participants | 72 Participants | 152 Participants | — |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 45 Participants | 57 Participants | 102 Participants | — |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 6 Participants | 2 Participants | 8 Participants | — |
| Ethnicity (NIH/OMB) Children Hispanic or Latino | 87 Participants | 83 Participants | 170 Participants | — |
| Ethnicity (NIH/OMB) Children Not Hispanic or Latino | 38 Participants | 44 Participants | 82 Participants | — |
| Ethnicity (NIH/OMB) Children Unknown or Not Reported | 5 Participants | 2 Participants | 7 Participants | — |
| Ethnicity (NIH/OMB) Teachers Hispanic or Latino | — | — | 96 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Teachers Not Hispanic or Latino | — | — | 178 Participants | 178 Participants |
| Ethnicity (NIH/OMB) Teachers Unknown or Not Reported | — | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Caregivers Asian | 5 Participants | 2 Participants | 7 Participants | — |
| Race (NIH/OMB) Caregivers Black or African American | 8 Participants | 9 Participants | 17 Participants | — |
| Race (NIH/OMB) Caregivers More than one race | 7 Participants | 12 Participants | 19 Participants | — |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 86 Participants | 74 Participants | 160 Participants | — |
| Race (NIH/OMB) Caregivers White | 25 Participants | 34 Participants | 59 Participants | — |
| Race (NIH/OMB) Children American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants | — |
| Race (NIH/OMB) Children Asian | 3 Participants | 2 Participants | 5 Participants | — |
| Race (NIH/OMB) Children Black or African American | 7 Participants | 12 Participants | 19 Participants | — |
| Race (NIH/OMB) Children More than one race | 10 Participants | 4 Participants | 14 Participants | — |
| Race (NIH/OMB) Children Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Children Unknown or Not Reported | 77 Participants | 69 Participants | 146 Participants | — |
| Race (NIH/OMB) Children White | 32 Participants | 41 Participants | 73 Participants | — |
| Race (NIH/OMB) Teachers American Indian or Alaska Native | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Teachers Asian | 0 Participants | 0 Participants | 24 Participants | 24 Participants |
| Race (NIH/OMB) Teachers Black or African American | 0 Participants | 0 Participants | 16 Participants | 16 Participants |
| Race (NIH/OMB) Teachers More than one race | 0 Participants | 0 Participants | 15 Participants | 15 Participants |
| Race (NIH/OMB) Teachers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Teachers Unknown or Not Reported | 0 Participants | 0 Participants | 95 Participants | 95 Participants |
| Race (NIH/OMB) Teachers White | 0 Participants | 0 Participants | 122 Participants | 122 Participants |
| Region of Enrollment United States | 261 participants | 260 participants | 959 participants | 438 participants |
| Sex: Female, Male Caregivers Female | 128 Participants | 124 Participants | 252 Participants | — |
| Sex: Female, Male Caregivers Male | 3 Participants | 7 Participants | 10 Participants | — |
| Sex: Female, Male Children Female | 51 Participants | 40 Participants | 91 Participants | — |
| Sex: Female, Male Children Male | 79 Participants | 89 Participants | 168 Participants | — |
| Sex: Female, Male Teachers Female | — | — | 258 Participants | 258 Participants |
| Sex: Female, Male Teachers Male | — | — | 16 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 261 | 0 / 260 | 0 / 0 |
| other Total, other adverse events | 0 / 261 | 0 / 260 | 0 / 0 |
| serious Total, serious adverse events | 0 / 261 | 0 / 260 | 0 / 0 |
Outcome results
Primary
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
Population: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow up surveys).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BPT-E | Change From Baseline in Child Behavior Problems (Parent Report) | Baseline | 73.60 score on a scale | Standard Deviation 27.77 |
| BPT-E | Change From Baseline in Child Behavior Problems (Parent Report) | Immediately after 16-week intervention | 71.49 score on a scale | Standard Deviation 29.51 |
| BPT-E | Change From Baseline in Child Behavior Problems (Parent Report) | 6-month follow-up | 67.85 score on a scale | Standard Deviation 29.51 |
| BPT-E | Change From Baseline in Child Behavior Problems (Parent Report) | 12-month follow-up | 66.48 score on a scale | Standard Deviation 29.43 |
| BPT-M | Change From Baseline in Child Behavior Problems (Parent Report) | 12-month follow-up | 68.25 score on a scale | Standard Deviation 31.39 |
| BPT-M | Change From Baseline in Child Behavior Problems (Parent Report) | Baseline | 77.95 score on a scale | Standard Deviation 26.99 |
| BPT-M | Change From Baseline in Child Behavior Problems (Parent Report) | 6-month follow-up | 70.67 score on a scale | Standard Deviation 33.17 |
| BPT-M | Change From Baseline in Child Behavior Problems (Parent Report) | Immediately after 16-week intervention | 71.69 score on a scale | Standard Deviation 30.4 |
p-value: 0.361t-test, 2 sided
p-value: 0.126t-test, 2 sided
p-value: 0t-test, 2 sided
p-value: 0t-test, 2 sided
p-value: 0t-test, 2 sided
p-value: 0t-test, 2 sided
Secondary
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
Population: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow-up surveys).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BPT-E | Change From Baseline in Parenting Behavior (Parent Report) | Baseline | 3.85 score on a scale | Standard Deviation 1.21 |
| BPT-E | Change From Baseline in Parenting Behavior (Parent Report) | Immediately after 16-week intervention | 4.02 score on a scale | Standard Deviation 0.92 |
| BPT-E | Change From Baseline in Parenting Behavior (Parent Report) | 6-month follow-up | 4.10 score on a scale | Standard Deviation 1.04 |
| BPT-E | Change From Baseline in Parenting Behavior (Parent Report) | 12-month follow-up | 4.15 score on a scale | Standard Deviation 0.94 |
| BPT-M | Change From Baseline in Parenting Behavior (Parent Report) | 12-month follow-up | 4.10 score on a scale | Standard Deviation 0.99 |
| BPT-M | Change From Baseline in Parenting Behavior (Parent Report) | Baseline | 3.90 score on a scale | Standard Deviation 1.03 |
| BPT-M | Change From Baseline in Parenting Behavior (Parent Report) | 6-month follow-up | 4.13 score on a scale | Standard Deviation 1.06 |
| BPT-M | Change From Baseline in Parenting Behavior (Parent Report) | Immediately after 16-week intervention | 4.12 score on a scale | Standard Deviation 1.02 |
p-value: 0.035t-test, 2 sided
p-value: 0.001t-test, 2 sided
p-value: 0t-test, 2 sided
p-value: 0t-test, 2 sided
p-value: 0t-test, 2 sided
p-value: 0t-test, 2 sided
Secondary
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
Population: Number of participants differs between baseline and follow-up due to attrition (e.g., participants not returning follow-up surveys).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BPT-E | Change From Baseline in Parenting Stress (Parent Self-Report) | Baseline | 113.70 score on a scale | Standard Deviation 20.01 |
| BPT-E | Change From Baseline in Parenting Stress (Parent Self-Report) | Immediately After 16-week Intervention | 101.23 score on a scale | Standard Deviation 21.73 |
| BPT-E | Change From Baseline in Parenting Stress (Parent Self-Report) | 6-month Follow-up | 97.72 score on a scale | Standard Deviation 25.08 |
| BPT-E | Change From Baseline in Parenting Stress (Parent Self-Report) | 12-month Follow-up | 96.21 score on a scale | Standard Deviation 20.73 |
| BPT-M | Change From Baseline in Parenting Stress (Parent Self-Report) | 12-month Follow-up | 94.93 score on a scale | Standard Deviation 26.4 |
| BPT-M | Change From Baseline in Parenting Stress (Parent Self-Report) | Baseline | 115.28 score on a scale | Standard Deviation 20.86 |
| BPT-M | Change From Baseline in Parenting Stress (Parent Self-Report) | 6-month Follow-up | 96.89 score on a scale | Standard Deviation 22.33 |
| BPT-M | Change From Baseline in Parenting Stress (Parent Self-Report) | Immediately After 16-week Intervention | 100.10 score on a scale | Standard Deviation 20.8 |
p-value: 0t-test, 2 sided
p-value: 0t-test, 2 sided
p-value: 0t-test, 2 sided
p-value: 0t-test, 2 sided
p-value: 0t-test, 2 sided
p-value: 0t-test, 2 sided