Trial Outcomes & Findings for Longitudinal Follow-up of Brief Parenting Interventions to Reduce Risk of Child Physical Maltreatment (NCT NCT04059185)

Results Overview

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 of spanking at the post-intervention timepoint.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1133 participants

Primary outcome timeframe

Baseline, 3 months post-intervention, 4 years post-intervention

Results posted on

2024-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	Program 1 (Triple P-Level 2) Triple P-Level 2 (TPL2), parenting education and consultation Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice.	Program 2 (Play Nicely) Play Nicely (PN), multimedia, computer-based parenting education Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes.	Control Our "usual care" control group participants receive a resource and referral list for local social services
Longitudinal Assessment-Adults Only STARTED	289	294	297
Longitudinal Assessment-Adults Only Completed Baseline Survey and Study Condition	272	271	280
Longitudinal Assessment-Adults Only Completed 3 Month Post-intervention Survey	243	239	258
Longitudinal Assessment-Adults Only Completed 4 Year Post-intervention Survey	142	133	165
Longitudinal Assessment-Adults Only COMPLETED	81	72	100
Longitudinal Assessment-Adults Only NOT COMPLETED	208	222	197
4 Year Post-Intervention Clinic-Children STARTED	81	72	100
4 Year Post-Intervention Clinic-Children COMPLETED	81	72	100
4 Year Post-Intervention Clinic-Children NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Program 1 (Triple P-Level 2) Triple P-Level 2 (TPL2), parenting education and consultation Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice.	Program 2 (Play Nicely) Play Nicely (PN), multimedia, computer-based parenting education Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes.	Control Our "usual care" control group participants receive a resource and referral list for local social services
Longitudinal Assessment-Adults Only Lost to Follow-up	187	195	177
Longitudinal Assessment-Adults Only Protocol Violation	11	13	13
Longitudinal Assessment-Adults Only Withdrawal by Subject	2	2	1
Longitudinal Assessment-Adults Only Baseline survey incomplete	4	8	3
Longitudinal Assessment-Adults Only Death	4	4	3

Baseline Characteristics

The numbers entered for "adults" reflect the number of participants who completed the baseline portion of the overall study. The numbers of "index children" entered reflect those who participated in the 4 year post-intervention clinic visit (also known as the "dyadic visit").

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline, 3 months post-intervention, 4 years post-intervention

Population: All available survey data for each time point was used. The baseline to 4 year post-intervention "number analyzed" differs from the baseline to 3 month post-intervention due to study attrition (lost to follow-up).

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 of spanking at the post-intervention timepoint.

Outcome measures

Outcome measures
Measure	Program 1 (Triple P-Level 2) n=242 Participants Triple P-Level 2 (TPL2), parenting education and consultation Triple P-Level 2: Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice.	Program 2 (Play Nicely) n=239 Participants Play Nicely (PN), multimedia, computer-based parenting education Play Nicely: Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes.	Control n=258 Participants Our "usual care" control group participants receive a resource and referral list for local social services Usual care: Our "usual care" control group participants receive a resource and referral list for local social services
Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up Baseline to 3 month post-intervention	-.32 score on a scale Standard Deviation 1.6	-.27 score on a scale Standard Deviation 1.4	-.17 score on a scale Standard Deviation 1.4
Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up Baseline to 4 years post-intervention	-.69 score on a scale Standard Deviation 1.5	-.68 score on a scale Standard Deviation 1.6	-.80 score on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: Baseline, 3 months post-intervention, 4 years post-intervention

Population: All available survey data for each time point was used. The baseline to 4 year post-intervention "number analyzed" differs from the baseline to 3 month post-intervention due to study attrition (lost to follow-up).

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.

Outcome measures

Outcome measures
Measure	Program 1 (Triple P-Level 2) n=241 Participants Triple P-Level 2 (TPL2), parenting education and consultation Triple P-Level 2: Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice.	Program 2 (Play Nicely) n=237 Participants Play Nicely (PN), multimedia, computer-based parenting education Play Nicely: Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes.	Control n=253 Participants Our "usual care" control group participants receive a resource and referral list for local social services Usual care: Our "usual care" control group participants receive a resource and referral list for local social services
Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up Baseline to 3 month post-intervention	-.86 score on a scale Standard Deviation 5.8	-2.1 score on a scale Standard Deviation 6.0	-.13 score on a scale Standard Deviation 5.0
Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up Baseline to 4 years post-intervention	-1.8 score on a scale Standard Deviation 6.6	-2.5 score on a scale Standard Deviation 7.1	-1.9 score on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: Baseline, 3 months post-intervention, 4 years post-intervention

Population: All available survey data for each time point was used. The baseline, 3 month post-intervention, and 4 year post-intervention "number analyzed" differs due to study attrition (lost to follow-up).

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.

Outcome measures

Outcome measures
Measure	Program 1 (Triple P-Level 2) n=268 Participants Triple P-Level 2 (TPL2), parenting education and consultation Triple P-Level 2: Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice.	Program 2 (Play Nicely) n=271 Participants Play Nicely (PN), multimedia, computer-based parenting education Play Nicely: Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes.	Control n=280 Participants Our "usual care" control group participants receive a resource and referral list for local social services Usual care: Our "usual care" control group participants receive a resource and referral list for local social services
Parent - Child Discipline Practices 3 month post-intervention	45.1 score on a scale Standard Error 5.3	44.9 score on a scale Standard Error 5.1	44.7 score on a scale Standard Error 4.9
Parent - Child Discipline Practices 4 years post-intervention	43.7 score on a scale Standard Error 5.8	44.2 score on a scale Standard Error 5.7	44.5 score on a scale Standard Error 5.3
Parent - Child Discipline Practices Baseline	44.1 score on a scale Standard Error 4.9	44.1 score on a scale Standard Error 4.8	45 score on a scale Standard Error 4.6

SECONDARY outcome

Timeframe: Baseline, 3 months post-intervention, 4 years post-intervention

Population: All available survey data for each time point was used. The baseline, 3 month post-intervention, and 4 year post-intervention "number analyzed" differs due to study attrition (lost to follow-up).

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.