Trial Outcomes & Findings for Technology-Enhanced Helping the Noncompliant Child (NCT NCT01367847)
NCT ID: NCT01367847
Last Updated: 2019-09-11
Results Overview
Retention assesses whether or not the family completed the full treatment program.
COMPLETED
NA
22 participants
Baseline to Post-Intervention (average 8 to 12 weeks)
2019-09-11
Participant Flow
Children are participants (i.e., N = # children); however, parents participate with young children in BPT (i.e., reference to parent-child dyads throughout). 22 parent-child dyads enrolled, 3 assigned as practice cases, given the pilot nature of the study (i.e., 19 for analyses), \& 4 drop-outs, yielded N = 15 for analysis.
Participant milestones
| Measure |
Helping the Noncompliant Child
Helping the Noncompliant Child (HNC) is a well-established behavioral parent training (BPTP program for parents of 3 to 8 year old children with externalizing problems. Children are the target of treatment; however, parents are the mechanism of change. Therefore, parent-child dyads participate.
|
TE-HNC
Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice \& child behavior, reminders re: practice \& sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Helping the Noncompliant Child
Helping the Noncompliant Child (HNC) is a well-established behavioral parent training (BPTP program for parents of 3 to 8 year old children with externalizing problems. Children are the target of treatment; however, parents are the mechanism of change. Therefore, parent-child dyads participate.
|
TE-HNC
Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice \& child behavior, reminders re: practice \& sessions.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Technology-Enhanced Helping the Noncompliant Child
Baseline characteristics by cohort
| Measure |
Helping the Noncompliant Child
n=10 Participants
Helping the Noncompliant Child (HNC) is a well-established behavioral parent training (BPTP program for parents of 3 to 8 year old children with externalizing problems. Children are the target of treatment; however, parents are the mechanism of change. Therefore, parent-child dyads participate.
|
TE-HNC
n=9 Participants
Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice \& child behavior, reminders re: practice \& sessions.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.75 Years
STANDARD_DEVIATION 2.12 • n=5 Participants
|
5.57 Years
STANDARD_DEVIATION 1.27 • n=7 Participants
|
5.67 Years
STANDARD_DEVIATION 1.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Minority (Racial and/or Ethnic)
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Post-Intervention (average 8 to 12 weeks)Population: Given that these analyses focus on retention, the analysis sample is the 19 enrolled parent-child dyads (i.e., including the drop-outs)
Retention assesses whether or not the family completed the full treatment program.
Outcome measures
| Measure |
Helping the Noncompliant Child
n=10 Participants
Helping the Noncompliant Child (HNC) is a well-established behavioral parent training (BPTP program for parents of 3 to 8 year old children with externalizing problems. Children are the target of treatment; however, parents are the mechanism of change. Therefore, parent-child dyads participate.
|
TE-HNC
n=9 Participants
Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice \& child behavior, reminders re: practice \& sessions.
|
|---|---|---|
|
Retention
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Post-Intervention (average 8 to 12 weeks)Population: Given the pilot nature of study and smalll sample size, intent to treat analyses were not conducted. Rather, analyses were conducted on those parent-child dyads who completed all sessions within each group.
Participation in each weekly session as scheduled was recorded for each family. Mean attendance of scheduled sessions was computed for each parent-child dyad and then for each group. For example, if a parent-child dyad required 8 sessions to master the program skills and attended all 8 sessions as scheduled they would have 100%. If instead, another parent-child dyad also required 8 sessions to complete the program, but half of those were rescheduled at least once. Then the overall average attendance is calculated across the parent-child dyads in each group. Greater scheduled attendance = optimal outcome.
Outcome measures
| Measure |
Helping the Noncompliant Child
n=8 Participants
Helping the Noncompliant Child (HNC) is a well-established behavioral parent training (BPTP program for parents of 3 to 8 year old children with externalizing problems. Children are the target of treatment; however, parents are the mechanism of change. Therefore, parent-child dyads participate.
|
TE-HNC
n=7 Participants
Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice \& child behavior, reminders re: practice \& sessions.
|
|---|---|---|
|
Mean % Sessions Attended as Scheduled
|
90 percentage of scheduled sessions
Standard Deviation 11
|
97 percentage of scheduled sessions
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Baseline to Post-Intervention (average 8 to 12 weeks)Population: N = 15 parent-child dyads who completed the treatment program.
The ECBI is a 36 item measure frequently used in treatment outcome research with young children, as it it reflects problem behavior in this age range and is sensitive to change. Parents rate the frequency of each problem behavior as occurring 0 = never to 7 = always. Scores can range from 0 to 252 with higher scores reflecting greater problem behaviors.
Outcome measures
| Measure |
Helping the Noncompliant Child
n=8 Participants
Helping the Noncompliant Child (HNC) is a well-established behavioral parent training (BPTP program for parents of 3 to 8 year old children with externalizing problems. Children are the target of treatment; however, parents are the mechanism of change. Therefore, parent-child dyads participate.
|
TE-HNC
n=7 Participants
Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice \& child behavior, reminders re: practice \& sessions.
|
|---|---|---|
|
Mean Post-treatment Score Eyberg Child Behavior Inventory (ECBI)
|
91.63 units on a scale
Standard Deviation 21.25
|
83.00 units on a scale
Standard Deviation 15.34
|
SECONDARY outcome
Timeframe: Baseline to Post-Intervention (Average 8 to 12 weeks)Population: N = 15 parent-child dyads who completed the treatment program.
Mean number of sessions that parent-child dyads in each group required to master the program skills and complete treatment (Fewer sessions to complete treatment considered more cost-effective as parent-child dyads learning skills more efficiently).
Outcome measures
| Measure |
Helping the Noncompliant Child
n=8 Participants
Helping the Noncompliant Child (HNC) is a well-established behavioral parent training (BPTP program for parents of 3 to 8 year old children with externalizing problems. Children are the target of treatment; however, parents are the mechanism of change. Therefore, parent-child dyads participate.
|
TE-HNC
n=7 Participants
Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice \& child behavior, reminders re: practice \& sessions.
|
|---|---|---|
|
Mean Sessions for Complete Treatment
|
10 Sessions
Interval 7.0 to 12.0
|
8 Sessions
Interval 7.0 to 10.0
|
SECONDARY outcome
Timeframe: Post-Intervention (Average 8 to 12 weeks)Population: N = 15 parent-child dyads who completed the treatment program.
Average parent-reported satisfaction with the treatment program on a project-developed consumer satisfaction scale (Possible range = 11 -77; Higher score = greater satisfaction).
Outcome measures
| Measure |
Helping the Noncompliant Child
n=8 Participants
Helping the Noncompliant Child (HNC) is a well-established behavioral parent training (BPTP program for parents of 3 to 8 year old children with externalizing problems. Children are the target of treatment; however, parents are the mechanism of change. Therefore, parent-child dyads participate.
|
TE-HNC
n=7 Participants
Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice \& child behavior, reminders re: practice \& sessions.
|
|---|---|---|
|
Mean Consumer Satisfaction
|
56.56 score on a scale
Standard Deviation 2.47
|
59.83 score on a scale
Standard Deviation 1.94
|
Adverse Events
Helping the Noncompliant Child
TE-HNC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Deborah Jones, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place