NCT04059185

Longitudinal Follow-up of Brief Parenting Interventions to Reduce Risk of Child Physical Maltreatment

Completed NA Results posted Last updated 20 December 2024

What this trial tests

NA trial testing Triple P-Level 2 in Parenting in 1,133 participants. Completed in 21 November 2022.

Timeline

5 November 2014

Primary endpoint
21 November 2022

21 November 2022

Quick facts

Lead sponsor	Tulane University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	1,133
Start date	5 November 2014
Primary completion	21 November 2022
Estimated completion	21 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Triple P-Level 2
• Play Nicely
• Usual care

Conditions studied

• Parenting — all drugs for Parenting →
• Child Behavior — all drugs for Child Behavior →
• Child Rearing — all drugs for Child Rearing →

Sponsor

Tulane University

Who can join

2 and older, any sex, with Parenting or Child Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up Primary · Baseline, 3 months post-intervention, 4 years post-intervention

The measure was collected at baseline, 3 month post-intervention, and 4 year post-intervention. This question asks participants "How often on average in the past month have you spanked your child?" with seven categories: 0) never, 1) once or twice in the past month, 2) about once a week, 3) about twice a week, 4) about once every other day, 5) about once a day, and 6) more than once a day. Using the 0-6 score response range, the outcome was calculated by subtracting the baseline score from the 3 month or 4 year post-intervention score, such that a negative score indicates decrease in frequency

Baseline to 3 month post-intervention

Group	Value	95% CI
Program 1 (Triple P-Level 2)	-.32	± 1.6
Program 2 (Play Nicely)	-.27	± 1.4
Control	-.17	± 1.4

Baseline to 4 years post-intervention

Group	Value	95% CI
Program 1 (Triple P-Level 2)	-.69	± 1.5
Program 2 (Play Nicely)	-.68	± 1.6
Control	-.80	± 1.8

Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up Primary · Baseline, 3 months post-intervention, 4 years post-intervention

The Attitudes Towards Spanking (ATS) scale was collected at baseline, 3 months post-intervention, and 4 years post-intervention. The scale score response range was 0-28, with a higher number being stronger support for spanking. This change outcome was calculated by subtracting the baseline score from the 3 month or 4 year post-intervention score, such that a negative score indicates a decrease in approval of spanking at the post-intervention time point.

Baseline to 3 month post-intervention

Group	Value	95% CI
Program 1 (Triple P-Level 2)	-.86	± 5.8
Program 2 (Play Nicely)	-2.1	± 6.0
Control	-.13	± 5.0

Baseline to 4 years post-intervention

Group	Value	95% CI
Program 1 (Triple P-Level 2)	-1.8	± 6.6
Program 2 (Play Nicely)	-2.5	± 7.1
Control	-1.9	± 6.3

Parent - Child Discipline Practices Secondary · Baseline, 3 months post-intervention, 4 years post-intervention

The Parental Discipline scale of the Parenting and Family Adjustment Scale (PAFAS) was collected at baseline, 3 month follow up, and long-term follow-up. This scale ranges from 0-54, with a higher number indicating more positive parenting.

Baseline

Group	Value	95% CI
Program 1 (Triple P-Level 2)	44.1	± 4.9
Program 2 (Play Nicely)	44.1	± 4.8
Control	45	± 4.6

3 month post-intervention

Group	Value	95% CI
Program 1 (Triple P-Level 2)	45.1	± 5.3
Program 2 (Play Nicely)	44.9	± 5.1
Control	44.7	± 4.9

4 years post-intervention

Group	Value	95% CI
Program 1 (Triple P-Level 2)	43.7	± 5.8
Program 2 (Play Nicely)	44.2	± 5.7
Control	44.5	± 5.3

Child - Behavioral and Emotional Adjustment Secondary · Baseline, 3 months post-intervention, 4 years post-intervention

The Child Adjustment and Parent Efficacy Scale (CAPES) scale was collected at baseline, 3 month follow-up, and long-term follow-up. This scale ranges from 0-81, with a higher number indicating increased levels of emotional or behavioral problems.

Baseline

Group	Value	95% CI
Program 1 (Triple P-Level 2)	21	± 12.3
Program 2 (Play Nicely)	21.5	± 12.5
Control	20.8	± 12.8

3 month post-intervention

Group	Value	95% CI
Program 1 (Triple P-Level 2)	18.9	± 11.9
Program 2 (Play Nicely)	20.6	± 11.8
Control	20.6	± 12.6

4 years post-intervention

Group	Value	95% CI
Program 1 (Triple P-Level 2)	17.2	± 12
Program 2 (Play Nicely)	19.3	± 13.8
Control	17.9	± 14.5

Child - Externalizing, Internalizing, and Total Symptoms Secondary · 4 years post-intervention

The 113 item Child Behavior Checklist (CBCL) scale was collected at 4 year long-term follow-up. The outcome is a T-score calculated for total symptoms, with a higher score indicating more internalizing and externalizing behaviors. For the T-score of the CBCL, the population mean is 50 and the standard deviation is 10. T-Scores less than 60 are considered to be in the normal range, the borderline range consists of T-scores of 60-63, and the clinical range consists of T-scores greater than 63.

Group	Value	95% CI
Program 1 (Triple P-Level 2)	51.1	± 11
Program 2 (Play Nicely)	51.2	± 10.9
Control	51.3	± 13.3

Parent Sensitivity Secondary · 4 years post-intervention

The outcome measure reported is the parent sensitivity score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-115. A higher score indicates a higher level of parent sensitivity from caregiver to child.

Challenge task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	67.34	± 14.82
Program 2 (Play Nicely)	68.43	± 14.23
Control	69.03	± 14.49

Social interaction task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	72.75	± 15.48
Program 2 (Play Nicely)	73.15	± 15.63
Control	70.68	± 18.50

Child Social Involvement Secondary · 4 years post-intervention

The outcome measure reported is the child social involvement score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-70. A higher score indicates a higher level of child social involvement from caregiver to child.

Challenge task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	46.16	± 6.66
Program 2 (Play Nicely)	47.39	± 6.84
Control	47.27	± 6.23

Social interaction task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	48.91	± 11.79
Program 2 (Play Nicely)	50.18	± 11.54
Control	50.24	± 11.90

Child Negative Emotionality Secondary · 4 years post-intervention

The outcome measure reported is the child negative emotionality score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-30. A higher score indicates a higher level of child negative emotionality from child.

Challenge task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	8.43	± 2.44
Program 2 (Play Nicely)	8.01	± 1.93
Control	8.21	± 2.04

Social interaction task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	10.13	± 3.58
Program 2 (Play Nicely)	9.77	± 3.18
Control	9.76	± 3.38

Dyadic Negative States Secondary · 4 years post-intervention

The outcome measure reported is the dyadic negative states score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-10. A higher score indicates a higher level of dyadic negative states between caregiver and child.

Challenge task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	3.36	± 1.61
Program 2 (Play Nicely)	3.16	± 1.46
Control	3.06	± 1.52

Social interaction task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	3.41	± 1.40
Program 2 (Play Nicely)	3.37	± 1.54
Control	3.58	± 1.84

Dyadic Reciprocity Secondary · 4 years post-intervention

The outcome measure reported is the dyadic reciprocity score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-15. A higher score indicates a higher level of dyadic reciprocity between caregiver and child.

Challenge task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	3.11	± 1.09
Program 2 (Play Nicely)	3.41	± 1.03
Control	3.23	± .99

Social interaction task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	3.01	± .90
Program 2 (Play Nicely)	3	± .94
Control	3.01	± 1.05

Parent Limit Setting Secondary · 4 years post-intervention

The outcome measure reported is the parent limit setting score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-35. A higher score indicates a higher level of parent limit setting from caregiver.

Challenge task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	29.72	± 3.76
Program 2 (Play Nicely)	29.69	± 4.27
Control	30.11	± 3.27

Social interaction task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	27.24	± 4.78
Program 2 (Play Nicely)	27.86	± 4.51
Control	26.64	± 5.53

Child Compliance Secondary · 4 years post-intervention

The outcome measure reported is the child compliance score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-20. A higher score indicates a higher level child compliance.

Challenge task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	14.87	± 2.57
Program 2 (Play Nicely)	15.35	± 2.01
Control	15.19	± 2.05

Social interaction task at the 4 years post-intervention clinic visit

Group	Value	95% CI
Program 1 (Triple P-Level 2)	13.85	± 2.59
Program 2 (Play Nicely)	14.24	± 2.61
Control	14.27	± 2.42

Sponsor's own description

Universal and broad selective parenting education programs that improve parenting skills, increase parents' understanding of child development, and teach positive child discipline strategies can prevent use of corporal punishment and child physical maltreatment. The proposed research addresses this critical need by investigating brief, relatively low-resource intensive primary prevention parenting programs that can be disseminated widely. By reducing cumulative adverse childhood experiences, which include child physical maltreatment, these interventions are expected to reduce long-term health disparities and risks for major public health problems, such as violence, smoking, obesity, drug abuse, risky sexual behavior, mental health disorders, and heart disease, among others

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.