Adults 14 to 21, female only, with Chronic Toxic Stress or Developmental/ Behavioral Regression in Young Children. 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.
Protective Factors Survey ScorePrimary· Week 1
The Protective Factors Survey (PFS) is a 20-item measure - The PFS is a validated parent survey designed that assesses protective factors in five areas: family functioning/resiliency, social emotional support, concrete support, nurturing and attachment, and knowledge of parenting/child development - Each subscale is rated 1-7; higher is better - range is 35-175
Group
Value
95% CI
"Hybrid" PAT Model
104.7
± 12.7
"Traditional" Parents as Teachers (PAT)
98
± 4.7
Protective Factors Survey ScorePrimary· Week 6
The Protective Factors Survey (PFS) is a 20-item measure - The PFS is a validated parent survey designed that assesses protective factors in five areas: family functioning/resiliency, social emotional support, concrete support, nurturing and attachment, and knowledge of parenting/child development - Each subscale is rated 1-7; higher is better - range is 35-175
Group
Value
95% CI
"Hybrid" PAT Model
104.1
± 10
"Traditional" Parents as Teachers (PAT)
101.8
± 7.9
Protective Factors Survey ScorePrimary· Month 6
The Protective Factors Survey (PFS) is a 20-item measure - The PFS is a validated parent survey designed that assesses protective factors in five areas: family functioning/resiliency, social emotional support, concrete support, nurturing and attachment, and knowledge of parenting/child development - Each subscale is rated 1-7; higher is better - range is 35-175
Group
Value
95% CI
"Hybrid" PAT Model
108
± 6.8
"Traditional" Parents as Teachers (PAT)
104.7
± 14
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3) ScorePrimary· Month 2
The Ages and Stages Questionnaire (ASQ 3) is a validated developmental screening designed for use by and with parents. The ASQ 3 screens for developmental milestones in communication, gross motor, fine motor, problem solving, and personal-social skills - Range is 0-60 for all age levels, higher is better
Group
Value
95% CI
"Hybrid" PAT Model
1
"Traditional" Parents as Teachers (PAT)
0
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3)Primary· Month 4
The Ages and Stages Questionnaire (ASQ 3) is a validated developmental screening designed for use by and with parents. The ASQ 3 screens for developmental milestones in communication, gross motor, fine motor, problem solving, and personal-social skills - Range is 0-60 for all age levels, higher is better
Group
Value
95% CI
"Hybrid" PAT Model
0
"Traditional" Parents as Teachers (PAT)
1
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3)Primary· Month 6
The Ages and Stages Questionnaire (ASQ 3) is a validated developmental screening designed for use by and with parents. The ASQ 3 screens for developmental milestones in communication, gross motor, fine motor, problem solving, and personal-social skills - Range is 0-60 for all age levels, higher is better
Group
Value
95% CI
"Hybrid" PAT Model
0
"Traditional" Parents as Teachers (PAT)
0
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) ScorePrimary· Month 2
The Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) is a validated screening of social and emotional behaviors - Range 0-240, Monitor with scores 25-34, score positive and refer with scores \>=35
Group
Value
95% CI
"Hybrid" PAT Model
0
"Traditional" Parents as Teachers (PAT)
0
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) ScorePrimary· Month 6
The Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) is a validated screening of social and emotional behaviors - Range 0-345, Monitor with scores 35-44 , score positive and refer with scores \>=45
Group
Value
95% CI
"Hybrid" PAT Model
0
"Traditional" Parents as Teachers (PAT)
0
The Patient Health Questionnaire (PHQ 9) ScorePrimary· Baseline
The Patient Health Questionnaire (PHQ 9) is a self-administered questionnaire that is validated for use in assessing the severity of depression.
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.
Group
Value
95% CI
"Hybrid" PAT Model
2.2
± 2.7
"Traditional" Parents as Teachers (PAT)
3.8
± 4.2
The Patient Health Questionnaire (PHQ 9) ScorePrimary· Month 6
The Patient Health Questionnaire (PHQ 9) is a self-administered questionnaire that is validated for use in assessing the severity of depression.
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.
Group
Value
95% CI
"Hybrid" PAT Model
4.6
± 6.0
"Traditional" Parents as Teachers (PAT)
3.3
± 3.5
The StimQ2-I Infant Cognitive Home Environment Questionnaire Score No Availability of Learning (ALM)Primary· Month 6
The StimQ2-I is a validated, interview-based assessment of home environments for use with infants ages five to 12 months. The StimQ2-I focuses on cognitive stimulation by the primary caregiver and contains several scales: Reading-Verbal, Parental Involvement in Developmental Advance, and Parental Verbal Responsivity - subscale range Read = 15, Parental Involvement in Developmental Advance (PIDA) = 5, Performance Validity Test (PVT) = 16 -Total STIMQ-I score range for the no ALM portion is 0-36; higher score is better.
Group
Value
95% CI
"Hybrid" PAT Model
29.4
± 4
"Traditional" Parents as Teachers (PAT)
20.3
± 11.1
Full STIMQ2-I Including Availability of Learning Materials (ALM)Primary· Month 6
The StimQ2-I is a validated, interview-based assessment of home environments for use with infants ages five to 12 months. The StimQ2-I focuses on cognitive stimulation by the primary caregiver and contains several scales: Availability of Learning Materials, Reading-Verbal, Parental Involvement in Developmental Advance, and Parental Verbal Responsivity - subscale range Read = 15, Parental Involvement in Developmental Advance (PIDA) = 5, Performance Validity Test (PVT) = 16, Availability of Learning Materials (ALM) = 6 Total score range for the STIMQ2-I including ALM is 0-42--a higher score is b
Group
Value
95% CI
"Hybrid" PAT Model
40.4
± 11.10
"Traditional" Parents as Teachers (PAT)
28
± 11.14
Sponsor's own description
Young Moms Program (YMP) is designed to address systemic barriers to the health and stability of young moms and their children such as the lack of coordination of service delivery or logistical barriers within the health system. The YMP also streamlines the referral pipeline, connecting moms to evidence-based resources, and ensuring children complete all recommended assessments prior to kindergarten.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05082857.