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Trial record 1 of 24 for:    Developmental Disabilities | ( Map: South Carolina, United States )
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Family Networks Project Study One: An Efficacy Study of Stepping Stones Triple P for Children Under Age Two

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ClinicalTrials.gov Identifier: NCT01424943
Recruitment Status : Completed
First Posted : August 29, 2011
Results First Posted : December 15, 2014
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Quality Improvement Center for Early Childhood
Information provided by (Responsible Party):
Cheri Shapiro, Ph.D., University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Prevent Child Maltreatment
Interventions Behavioral: Stepping Stones Triple P
Other: BabyNet Services As usual
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stepping Stones Triple P Plus IDEA Part C Services as Usual IDEA Part C Services As Usual
Hide Arm/Group Description

10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes

Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.

IDEA Part C services as usual based on IFSP
Period Title: Overall Study
Started 25 24
Completed 12 23
Not Completed 13 1
Arm/Group Title Stepping Stones Triple P Plus IDEA Part C Services as Usual IDEA Part C Services As Usual Total
Hide Arm/Group Description

10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes

Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.

IDEA Part C services as usual based on IFSP Total of all reporting groups
Overall Number of Baseline Participants 25 24 49
Hide Baseline Analysis Population Description
Parents of children with disabilities eligible for IDEA Part C Services and their identified child
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 25 participants 24 participants 49 participants
18.77  (3.64) 19.25  (3.13) 19.00  (3.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
Female
8
  32.0%
10
  41.7%
18
  36.7%
Male
17
  68.0%
14
  58.3%
31
  63.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   4.2%
1
   2.0%
Black or African American
7
  28.0%
5
  20.8%
12
  24.5%
White
14
  56.0%
11
  45.8%
25
  51.0%
More than one race
3
  12.0%
4
  16.7%
7
  14.3%
Unknown or Not Reported
1
   4.0%
3
  12.5%
4
   8.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 24 participants 49 participants
25 24 49
1.Primary Outcome
Title Parenting Style
Hide Description Parenting Scale (Total Score; measure of parenting style). 30 items on the scale, scores range from 1-7 for each item with higher scores indicating dysfunctional parenting styles (laxness, over-reactivity, hostility). Scores summed and divided by 30 for total score.
Time Frame Baseline, 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stepping Stones Triple P Plus IDEA Part C Services as Usual IDEA Part C Services As Usual
Hide Arm/Group Description:

10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes

Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.

IDEA Part C services as usual based on IFSP
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: scores on a scale
baseline Parenting Scale 2.65  (.57) 2.61  (.70)
Post-Tx Parenting Scale 2.09  (.73) 2.21  (.66)
2.Primary Outcome
Title Child Behavior
Hide Description Child Behavior Checklist 1/5-5. A parent report measure of child behavioral problems. The score used for this outcome was the CBCL Total Score, which is a T-Score. T scores average 50 with a standard deviation of 10. Scores above 65 considered in the clinical range.
Time Frame Baseline, 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stepping Stones Triple P Plus IDEA Part C Services as Usual IDEA Part C Services As Usual
Hide Arm/Group Description:

10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes

Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.

IDEA Part C services as usual based on IFSP
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: T-score
CBCL Total Score Baseline 53.56  (8.54) 51.00  (10.67)
CBCL Total Score Post-Tx 53.45  (10.91) 51.61  (9.09)
3.Primary Outcome
Title Parenting Self-confidence
Hide Description Toddler Care Questionnaire. Measures parent reported self-confidence in parenting a toddler. Parents rate their confidence in performing parenting tasks specific to toddlers. Higher scores indicate more confidence. Scores range from 37-185. The total sum score derived from adding the scores for the 37 items in this survey was used for this outcome measure.
Time Frame Baseline, 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stepping Stones Triple P Plus IDEA Part C Services as Usual IDEA Part C Services As Usual
Hide Arm/Group Description:

10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes

Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.

IDEA Part C services as usual based on IFSP
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 152.32  (21.93) 155.13  (19.19)
midpoint 157.45  (19.68) 159.17  (14.65)
4.Primary Outcome
Title KIPS
Hide Description KIPS observational measure of the quality of the parent-child relationship. scores range from 1-5. Higher scores indicate a higher quality of relationship.
Time Frame Baseline, 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stepping Stones Triple P Plus IDEA Part C Services as Usual IDEA Part C Services As Usual
Hide Arm/Group Description:

10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes

Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.

IDEA Part C services as usual based on IFSP
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Scores at 5 months 3.52  (.70) 3.52  (.63)
scores at Baseline 3.39  (.54) 3.52  (.59)
5.Secondary Outcome
Title Parent Symptoms of Depression, Anxiety and Stress
Hide Description DASS-21, brief screening measure of symptoms of depression, anxiety, and stress. Scores on each scale range from 0-21. Higher scores indicate more symptoms in each area.
Time Frame baseline, 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stepping Stones Triple P Plus IDEA Part C Services as Usual IDEA Part C Services As Usual
Hide Arm/Group Description:

10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes

Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.

IDEA Part C services as usual based on IFSP
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: scores on a scale
5 month DASS 21 Depression 3.00  (4.22) 4.09  (5.92)
5 month DASS 21 Anxiety 3.45  (3.56) 2.96  (5.25)
5 month DASS 21 Stress 9.55  (6.35) 10.70  (9.12)
baseline DASS 21 depression 4.80  (6.16) 4.58  (9.16)
baseline DASS 21 anxiety 3.68  (5.59) 3.50  (7.11)
baseline DASS 21 stress 11.20  (6.98) 10.83  (8.50)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stepping Stones Triple P Plus IDEA Part C Services as Usual IDEA Part C Services As Usual
Hide Arm/Group Description

10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes

Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.

IDEA Part C services as usual based on IFSP
All-Cause Mortality
Stepping Stones Triple P Plus IDEA Part C Services as Usual IDEA Part C Services As Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stepping Stones Triple P Plus IDEA Part C Services as Usual IDEA Part C Services As Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stepping Stones Triple P Plus IDEA Part C Services as Usual IDEA Part C Services As Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/24 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Cheri Shapiro
Organization: Institute for Families in Society, University of South Carolina
Phone: 803-777-8760
EMail: cshapiro@mailbox.sc.edu
Layout table for additonal information
Responsible Party: Cheri Shapiro, Ph.D., University of South Carolina
ClinicalTrials.gov Identifier: NCT01424943     History of Changes
Other Study ID Numbers: Pro00006462
First Submitted: July 27, 2011
First Posted: August 29, 2011
Results First Submitted: July 22, 2014
Results First Posted: December 15, 2014
Last Update Posted: April 18, 2019