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Family Networks Project Study One: An Efficacy Study of Stepping Stones Triple P for Children Under Age Two

The Family Networks Project Study One: Supporting Family Confidence, Competence, and Community Connections

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01424943
Enrollment
49
Registered
2011-08-29
Start date
2010-12-31
Completion date
2014-03-31
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevent Child Maltreatment

Keywords

prevention, evidence-based parenting intervention, children, disabilities, IDEA Part C, Stepping Stones Triple P

Brief summary

The purpose of the project is to assess the initial efficacy of Stepping Stones Triple P-Positive Parenting Program (SSTP) with parents of children below age two with developmental disabilities to strengthen families and prevent child maltreatment.

Detailed description

This study is an initial efficacy trial of SSTP for parents of children below age 2. The target population consists of 50 families of young children ages 11-23 months with developmental disabilities who are eligible to receive IDEA Part C (Individuals with Disabilities Education Act Part C) services in one region of South Carolina. Families will be randomly assigned to one of two conditions (1) IDEA Part C services as usual or (2) IDEA Part C services plus SSTP. Project goals are to strengthen parent competence, enhance parent confidence, and strengthen child social, emotional and behavioral functioning. Ultimately, this should result in a reduced likelihood of child maltreatment

Interventions

BEHAVIORALStepping Stones Triple P

10-12 session manualized intervention delivered in client homes

OTHERBabyNet Services As usual

BabyNet services as usual based on IFSP

Sponsors

Quality Improvement Center for Early Childhood
CollaboratorUNKNOWN
University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Months to 23 Months
Healthy volunteers
No

Inclusion criteria

* child age between 11 and 23 months of age * child eligible for IDEA Part C Services * parent english speaking * parent willing to allow in-home services

Exclusion criteria

* disability requiring extensive out of home treatment

Design outcomes

Primary

MeasureTime frameDescription
Parenting StyleBaseline, 5 monthsParenting 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.
Child BehaviorBaseline, 5 monthsChild 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.
Parenting Self-confidenceBaseline, 5 monthsToddler 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.
KIPSBaseline, 5 monthsKIPS observational measure of the quality of the parent-child relationship. scores range from 1-5. Higher scores indicate a higher quality of relationship.

Secondary

MeasureTime frameDescription
Parent Symptoms of Depression, Anxiety and Stressbaseline, 5 monthsDASS-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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Stepping Stones Triple P Plus IDEA Part C Services as Usual
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.
25
IDEA Part C Services As Usual
IDEA Part C services as usual based on IFSP
24
Total49

Baseline characteristics

CharacteristicStepping Stones Triple P Plus IDEA Part C Services as UsualTotalIDEA Part C Services As Usual
Age, Continuous18.77 months
STANDARD_DEVIATION 3.64
19.00 months
STANDARD_DEVIATION 3.76
19.25 months
STANDARD_DEVIATION 3.13
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
7 Participants12 Participants5 Participants
Race (NIH/OMB)
More than one race
3 Participants7 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants4 Participants3 Participants
Race (NIH/OMB)
White
14 Participants25 Participants11 Participants
Region of Enrollment
United States
25 participants49 participants24 participants
Sex: Female, Male
Female
8 Participants18 Participants10 Participants
Sex: Female, Male
Male
17 Participants31 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 250 / 24
serious
Total, serious adverse events
0 / 250 / 24

Outcome results

Primary

Child Behavior

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

ArmMeasureGroupValue (MEAN)Dispersion
Stepping Stones Triple P Plus IDEA Part C Services as UsualChild BehaviorCBCL Total Score Baseline53.56 T-scoreStandard Deviation 8.54
Stepping Stones Triple P Plus IDEA Part C Services as UsualChild BehaviorCBCL Total Score Post-Tx53.45 T-scoreStandard Deviation 10.91
IDEA Part C Services As UsualChild BehaviorCBCL Total Score Baseline51.00 T-scoreStandard Deviation 10.67
IDEA Part C Services As UsualChild BehaviorCBCL Total Score Post-Tx51.61 T-scoreStandard Deviation 9.09
Primary

KIPS

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

ArmMeasureGroupValue (MEAN)Dispersion
Stepping Stones Triple P Plus IDEA Part C Services as UsualKIPSScores at 5 months3.52 scores on a scaleStandard Deviation 0.7
Stepping Stones Triple P Plus IDEA Part C Services as UsualKIPSscores at Baseline3.39 scores on a scaleStandard Deviation 0.54
IDEA Part C Services As UsualKIPSScores at 5 months3.52 scores on a scaleStandard Deviation 0.63
IDEA Part C Services As UsualKIPSscores at Baseline3.52 scores on a scaleStandard Deviation 0.59
Primary

Parenting Self-confidence

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

ArmMeasureGroupValue (MEAN)Dispersion
Stepping Stones Triple P Plus IDEA Part C Services as UsualParenting Self-confidencebaseline152.32 units on a scaleStandard Deviation 21.93
Stepping Stones Triple P Plus IDEA Part C Services as UsualParenting Self-confidencemidpoint157.45 units on a scaleStandard Deviation 19.68
IDEA Part C Services As UsualParenting Self-confidencebaseline155.13 units on a scaleStandard Deviation 19.19
IDEA Part C Services As UsualParenting Self-confidencemidpoint159.17 units on a scaleStandard Deviation 14.65
Primary

Parenting Style

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

ArmMeasureGroupValue (MEAN)Dispersion
Stepping Stones Triple P Plus IDEA Part C Services as UsualParenting Stylebaseline Parenting Scale2.65 scores on a scaleStandard Deviation 0.57
Stepping Stones Triple P Plus IDEA Part C Services as UsualParenting StylePost-Tx Parenting Scale2.09 scores on a scaleStandard Deviation 0.73
IDEA Part C Services As UsualParenting Stylebaseline Parenting Scale2.61 scores on a scaleStandard Deviation 0.7
IDEA Part C Services As UsualParenting StylePost-Tx Parenting Scale2.21 scores on a scaleStandard Deviation 0.66
Secondary

Parent Symptoms of Depression, Anxiety and Stress

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

ArmMeasureGroupValue (MEAN)Dispersion
Stepping Stones Triple P Plus IDEA Part C Services as UsualParent Symptoms of Depression, Anxiety and Stressbaseline DASS 21 depression4.80 scores on a scaleStandard Deviation 6.16
Stepping Stones Triple P Plus IDEA Part C Services as UsualParent Symptoms of Depression, Anxiety and Stress5 month DASS 21 Depression3.00 scores on a scaleStandard Deviation 4.22
Stepping Stones Triple P Plus IDEA Part C Services as UsualParent Symptoms of Depression, Anxiety and Stress5 month DASS 21 Anxiety3.45 scores on a scaleStandard Deviation 3.56
Stepping Stones Triple P Plus IDEA Part C Services as UsualParent Symptoms of Depression, Anxiety and Stress5 month DASS 21 Stress9.55 scores on a scaleStandard Deviation 6.35
Stepping Stones Triple P Plus IDEA Part C Services as UsualParent Symptoms of Depression, Anxiety and Stressbaseline DASS 21 anxiety3.68 scores on a scaleStandard Deviation 5.59
Stepping Stones Triple P Plus IDEA Part C Services as UsualParent Symptoms of Depression, Anxiety and Stressbaseline DASS 21 stress11.20 scores on a scaleStandard Deviation 6.98
IDEA Part C Services As UsualParent Symptoms of Depression, Anxiety and Stressbaseline DASS 21 anxiety3.50 scores on a scaleStandard Deviation 7.11
IDEA Part C Services As UsualParent Symptoms of Depression, Anxiety and Stressbaseline DASS 21 depression4.58 scores on a scaleStandard Deviation 9.16
IDEA Part C Services As UsualParent Symptoms of Depression, Anxiety and Stress5 month DASS 21 Stress10.70 scores on a scaleStandard Deviation 9.12
IDEA Part C Services As UsualParent Symptoms of Depression, Anxiety and Stress5 month DASS 21 Depression4.09 scores on a scaleStandard Deviation 5.92
IDEA Part C Services As UsualParent Symptoms of Depression, Anxiety and Stressbaseline DASS 21 stress10.83 scores on a scaleStandard Deviation 8.5
IDEA Part C Services As UsualParent Symptoms of Depression, Anxiety and Stress5 month DASS 21 Anxiety2.96 scores on a scaleStandard Deviation 5.25

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026