Trial Outcomes & Findings for The Pro-Parenting Study: Helping Parents Reduce Behavior Problems in Preschool Children With Developmental Delay (NCT NCT03599648)
NCT ID: NCT03599648
Last Updated: 2025-03-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
959 participants
Primary outcome timeframe
baseline, immediately after 16-week intervention, 6 months, 12 months
Results posted on
2025-03-11
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
Teachers
Caregivers in both conditions were asked to identify a teacher at each wave of data collection who could provide an evaluation of the child's behavior outside the home. Teacher participation was not longitudinal, meaning that different teachers provided evaluations at each wave of data collection.
|
|---|---|---|---|
|
Overall Study
STARTED
|
261
|
260
|
438
|
|
Overall Study
Received Intervention as Assigned
|
107
|
114
|
0
|
|
Overall Study
Completed Follow-up Immediately After Intervention
|
186
|
192
|
0
|
|
Overall Study
Completed 6-month Follow-up
|
183
|
187
|
0
|
|
Overall Study
Completed 12-month Follow-up
|
194
|
201
|
0
|
|
Overall Study
COMPLETED
|
215
|
219
|
438
|
|
Overall Study
NOT COMPLETED
|
46
|
41
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One caregiver in the BPT-M condition did not answer question. Child age was measured in years in the first cohort but months in later cohorts. Given that age was measured differently for the first cohort, their data are not included here to simplify reporting. Teacher age was measured with ranges rather than exact years. These data are included in a separate table.
Baseline characteristics by cohort
| Measure |
BPT-E
n=261 Participants
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.
|
BPT-M
n=260 Participants
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.
|
Teachers
n=438 Participants
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.
|
Total
n=959 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Caregivers
|
37.31 years
STANDARD_DEVIATION 7.65 • n=131 Participants • One caregiver in the BPT-M condition did not answer question. Child age was measured in years in the first cohort but months in later cohorts. Given that age was measured differently for the first cohort, their data are not included here to simplify reporting. Teacher age was measured with ranges rather than exact years. These data are included in a separate table.
|
37.32 years
STANDARD_DEVIATION 7.64 • n=130 Participants • One caregiver in the BPT-M condition did not answer question. Child age was measured in years in the first cohort but months in later cohorts. Given that age was measured differently for the first cohort, their data are not included here to simplify reporting. Teacher age was measured with ranges rather than exact years. These data are included in a separate table.
|
—
|
37.31 years
STANDARD_DEVIATION 7.63 • n=261 Participants • One caregiver in the BPT-M condition did not answer question. Child age was measured in years in the first cohort but months in later cohorts. Given that age was measured differently for the first cohort, their data are not included here to simplify reporting. Teacher age was measured with ranges rather than exact years. These data are included in a separate table.
|
|
Age, Continuous
Children
|
4.28 years
STANDARD_DEVIATION 0.85 • n=105 Participants • One caregiver in the BPT-M condition did not answer question. Child age was measured in years in the first cohort but months in later cohorts. Given that age was measured differently for the first cohort, their data are not included here to simplify reporting. Teacher age was measured with ranges rather than exact years. These data are included in a separate table.
|
4.32 years
STANDARD_DEVIATION .88 • n=104 Participants • One caregiver in the BPT-M condition did not answer question. Child age was measured in years in the first cohort but months in later cohorts. Given that age was measured differently for the first cohort, their data are not included here to simplify reporting. Teacher age was measured with ranges rather than exact years. These data are included in a separate table.
|
—
|
4.30 years
STANDARD_DEVIATION .86 • n=209 Participants • One caregiver in the BPT-M condition did not answer question. Child age was measured in years in the first cohort but months in later cohorts. Given that age was measured differently for the first cohort, their data are not included here to simplify reporting. Teacher age was measured with ranges rather than exact years. These data are included in a separate table.
|
|
Age, Customized
18-25 years
|
—
|
—
|
29 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
29 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
|
Age, Customized
26-35 years
|
—
|
—
|
89 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
89 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
|
Age, Customized
36-45 years
|
—
|
—
|
65 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
65 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
|
Age, Customized
46-55 years
|
—
|
—
|
58 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
58 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
|
Age, Customized
56-65 years
|
—
|
—
|
29 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
29 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
|
Age, Customized
66 years and older
|
—
|
—
|
2 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
2 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
|
Age, Customized
prefer not to answer
|
—
|
—
|
2 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
2 Participants
n=274 Participants • Parent, child, and teacher age were all measured slightly differently, and thus appear in different tables. Teacher age was measured with ranges rather than exact years and those data are reported here. Age and demographic data were only collected from 274 teachers.
|
|
Sex: Female, Male
Caregivers · Female
|
128 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
124 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
—
|
252 Participants
n=262 Participants • Demographic data were only collected from 274 teachers.
|
|
Sex: Female, Male
Caregivers · Male
|
3 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
7 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
—
|
10 Participants
n=262 Participants • Demographic data were only collected from 274 teachers.
|
|
Sex: Female, Male
Children · Female
|
51 Participants
n=130 Participants • Demographic data were only collected from 274 teachers.
|
40 Participants
n=129 Participants • Demographic data were only collected from 274 teachers.
|
—
|
91 Participants
n=259 Participants • Demographic data were only collected from 274 teachers.
|
|
Sex: Female, Male
Children · Male
|
79 Participants
n=130 Participants • Demographic data were only collected from 274 teachers.
|
89 Participants
n=129 Participants • Demographic data were only collected from 274 teachers.
|
—
|
168 Participants
n=259 Participants • Demographic data were only collected from 274 teachers.
|
|
Sex: Female, Male
Teachers · Female
|
—
|
—
|
258 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
258 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
|
Sex: Female, Male
Teachers · Male
|
—
|
—
|
16 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
16 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
|
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
|
80 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
72 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
—
|
152 Participants
n=262 Participants • Demographic data were only collected from 274 teachers.
|
|
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
|
45 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
57 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
—
|
102 Participants
n=262 Participants • Demographic data were only collected from 274 teachers.
|
|
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
|
6 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
2 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
—
|
8 Participants
n=262 Participants • Demographic data were only collected from 274 teachers.
|
|
Ethnicity (NIH/OMB)
Children · Hispanic or Latino
|
87 Participants
n=130 Participants • Demographic data were only collected from 274 teachers.
|
83 Participants
n=129 Participants • Demographic data were only collected from 274 teachers.
|
—
|
170 Participants
n=259 Participants • Demographic data were only collected from 274 teachers.
|
|
Ethnicity (NIH/OMB)
Children · Not Hispanic or Latino
|
38 Participants
n=130 Participants • Demographic data were only collected from 274 teachers.
|
44 Participants
n=129 Participants • Demographic data were only collected from 274 teachers.
|
—
|
82 Participants
n=259 Participants • Demographic data were only collected from 274 teachers.
|
|
Ethnicity (NIH/OMB)
Children · Unknown or Not Reported
|
5 Participants
n=130 Participants • Demographic data were only collected from 274 teachers.
|
2 Participants
n=129 Participants • Demographic data were only collected from 274 teachers.
|
—
|
7 Participants
n=259 Participants • Demographic data were only collected from 274 teachers.
|
|
Ethnicity (NIH/OMB)
Teachers · Hispanic or Latino
|
—
|
—
|
96 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
96 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
|
Ethnicity (NIH/OMB)
Teachers · Not Hispanic or Latino
|
—
|
—
|
178 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
178 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
|
Ethnicity (NIH/OMB)
Teachers · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
0 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
0 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
0 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
—
|
0 Participants
n=262 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Caregivers · Asian
|
5 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
2 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
—
|
7 Participants
n=262 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
0 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
—
|
0 Participants
n=262 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
8 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
9 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
—
|
17 Participants
n=262 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Caregivers · White
|
25 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
34 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
—
|
59 Participants
n=262 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
7 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
12 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
—
|
19 Participants
n=262 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
86 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
74 Participants
n=131 Participants • Demographic data were only collected from 274 teachers.
|
—
|
160 Participants
n=262 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Children · American Indian or Alaska Native
|
1 Participants
n=130 Participants • Demographic data were only collected from 274 teachers.
|
1 Participants
n=129 Participants • Demographic data were only collected from 274 teachers.
|
—
|
2 Participants
n=259 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Children · Asian
|
3 Participants
n=130 Participants • Demographic data were only collected from 274 teachers.
|
2 Participants
n=129 Participants • Demographic data were only collected from 274 teachers.
|
—
|
5 Participants
n=259 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Children · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=130 Participants • Demographic data were only collected from 274 teachers.
|
0 Participants
n=129 Participants • Demographic data were only collected from 274 teachers.
|
—
|
0 Participants
n=259 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Children · Black or African American
|
7 Participants
n=130 Participants • Demographic data were only collected from 274 teachers.
|
12 Participants
n=129 Participants • Demographic data were only collected from 274 teachers.
|
—
|
19 Participants
n=259 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Children · White
|
32 Participants
n=130 Participants • Demographic data were only collected from 274 teachers.
|
41 Participants
n=129 Participants • Demographic data were only collected from 274 teachers.
|
—
|
73 Participants
n=259 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Children · More than one race
|
10 Participants
n=130 Participants • Demographic data were only collected from 274 teachers.
|
4 Participants
n=129 Participants • Demographic data were only collected from 274 teachers.
|
—
|
14 Participants
n=259 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Children · Unknown or Not Reported
|
77 Participants
n=130 Participants • Demographic data were only collected from 274 teachers.
|
69 Participants
n=129 Participants • Demographic data were only collected from 274 teachers.
|
—
|
146 Participants
n=259 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Teachers · American Indian or Alaska Native
|
0 Participants
Demographic data were only collected from 274 teachers.
|
0 Participants
Demographic data were only collected from 274 teachers.
|
2 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
2 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Teachers · Asian
|
0 Participants
Demographic data were only collected from 274 teachers.
|
0 Participants
Demographic data were only collected from 274 teachers.
|
24 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
24 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Teachers · Native Hawaiian or Other Pacific Islander
|
0 Participants
Demographic data were only collected from 274 teachers.
|
0 Participants
Demographic data were only collected from 274 teachers.
|
0 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
0 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Teachers · Black or African American
|
0 Participants
Demographic data were only collected from 274 teachers.
|
0 Participants
Demographic data were only collected from 274 teachers.
|
16 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
16 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Teachers · White
|
0 Participants
Demographic data were only collected from 274 teachers.
|
0 Participants
Demographic data were only collected from 274 teachers.
|
122 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
122 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Teachers · More than one race
|
0 Participants
Demographic data were only collected from 274 teachers.
|
0 Participants
Demographic data were only collected from 274 teachers.
|
15 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
15 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
|
Race (NIH/OMB)
Teachers · Unknown or Not Reported
|
0 Participants
Demographic data were only collected from 274 teachers.
|
0 Participants
Demographic data were only collected from 274 teachers.
|
95 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
95 Participants
n=274 Participants • Demographic data were only collected from 274 teachers.
|
|
Region of Enrollment
United States
|
261 participants
n=261 Participants • At baseline, 131 caregivers in the BPT-E and 131 caregivers in the BPT-M conditions provided baseline data about themselves and their child. However, only 128 children in each condition participated in play/ observation tasks at baseline (i.e., N=259 in each condition). At later waves, 3 children (2 in BPT-E and 1 in BPT-M) who did not participate in play tasks at baseline chose to do so, resulting in N=261 in BPT-E (131 parents + 130 children) and N=260 in BPT-M (131 parents + 129 children).
|
260 participants
n=260 Participants • At baseline, 131 caregivers in the BPT-E and 131 caregivers in the BPT-M conditions provided baseline data about themselves and their child. However, only 128 children in each condition participated in play/ observation tasks at baseline (i.e., N=259 in each condition). At later waves, 3 children (2 in BPT-E and 1 in BPT-M) who did not participate in play tasks at baseline chose to do so, resulting in N=261 in BPT-E (131 parents + 130 children) and N=260 in BPT-M (131 parents + 129 children).
|
438 participants
n=438 Participants • At baseline, 131 caregivers in the BPT-E and 131 caregivers in the BPT-M conditions provided baseline data about themselves and their child. However, only 128 children in each condition participated in play/ observation tasks at baseline (i.e., N=259 in each condition). At later waves, 3 children (2 in BPT-E and 1 in BPT-M) who did not participate in play tasks at baseline chose to do so, resulting in N=261 in BPT-E (131 parents + 130 children) and N=260 in BPT-M (131 parents + 129 children).
|
959 participants
n=959 Participants • At baseline, 131 caregivers in the BPT-E and 131 caregivers in the BPT-M conditions provided baseline data about themselves and their child. However, only 128 children in each condition participated in play/ observation tasks at baseline (i.e., N=259 in each condition). At later waves, 3 children (2 in BPT-E and 1 in BPT-M) who did not participate in play tasks at baseline chose to do so, resulting in N=261 in BPT-E (131 parents + 130 children) and N=260 in BPT-M (131 parents + 129 children).
|
PRIMARY outcome
Timeframe: baseline, immediately after 16-week intervention, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow up surveys).
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.
Outcome measures
| Measure |
BPT-E
n=121 Participants
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.
|
BPT-M
n=122 Participants
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.
|
|---|---|---|
|
Change From Baseline in Child Behavior Problems (Parent Report)
Baseline
|
73.60 score on a scale
Standard Deviation 27.77
|
77.95 score on a scale
Standard Deviation 26.99
|
|
Change From Baseline in Child Behavior Problems (Parent Report)
Immediately after 16-week intervention
|
71.49 score on a scale
Standard Deviation 29.51
|
71.69 score on a scale
Standard Deviation 30.40
|
|
Change From Baseline in Child Behavior Problems (Parent Report)
6-month follow-up
|
67.85 score on a scale
Standard Deviation 29.51
|
70.67 score on a scale
Standard Deviation 33.17
|
|
Change From Baseline in Child Behavior Problems (Parent Report)
12-month follow-up
|
66.48 score on a scale
Standard Deviation 29.43
|
68.25 score on a scale
Standard Deviation 31.39
|
SECONDARY outcome
Timeframe: baseline, immediately after 16-week intervention, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow-up surveys).
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.
Outcome measures
| Measure |
BPT-E
n=122 Participants
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.
|
BPT-M
n=118 Participants
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.
|
|---|---|---|
|
Change From Baseline in Parenting Behavior (Parent Report)
Baseline
|
3.85 score on a scale
Standard Deviation 1.21
|
3.90 score on a scale
Standard Deviation 1.03
|
|
Change From Baseline in Parenting Behavior (Parent Report)
Immediately after 16-week intervention
|
4.02 score on a scale
Standard Deviation 0.92
|
4.12 score on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Parenting Behavior (Parent Report)
6-month follow-up
|
4.10 score on a scale
Standard Deviation 1.04
|
4.13 score on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Parenting Behavior (Parent Report)
12-month follow-up
|
4.15 score on a scale
Standard Deviation 0.94
|
4.10 score on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: baseline, immediately after 16-week intervention, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up due to attrition (e.g., participants not returning follow-up surveys).
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.
Outcome measures
| Measure |
BPT-E
n=128 Participants
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.
|
BPT-M
n=129 Participants
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.
|
|---|---|---|
|
Change From Baseline in Parenting Stress (Parent Self-Report)
Baseline
|
113.70 score on a scale
Standard Deviation 20.01
|
115.28 score on a scale
Standard Deviation 20.86
|
|
Change From Baseline in Parenting Stress (Parent Self-Report)
Immediately After 16-week Intervention
|
101.23 score on a scale
Standard Deviation 21.73
|
100.10 score on a scale
Standard Deviation 20.80
|
|
Change From Baseline in Parenting Stress (Parent Self-Report)
6-month Follow-up
|
97.72 score on a scale
Standard Deviation 25.08
|
96.89 score on a scale
Standard Deviation 22.33
|
|
Change From Baseline in Parenting Stress (Parent Self-Report)
12-month Follow-up
|
96.21 score on a scale
Standard Deviation 20.73
|
94.93 score on a scale
Standard Deviation 26.40
|
Adverse Events
BPT-E
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BPT-M
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Teachers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place