About this trial
Purpose of this study is to test the preliminary efficacy, acceptability, accessibility, cost, and sustainability of an innovative mental health treatment model for young children from low-income, under-resourced communities through a partnership with Head Start programs in urban and rural communities in Maryland.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Child is 2-5 years old, enrolled in Baltimore City Head Start (Baltimore City Mayor's Office on Child & Family Success) or Head Start sites managed by Catholic Charities of MD
parent expresses concern about the child's behavior or need for parenting support
parent speaks English or Spanish
Parent age 18-99 years
Disqualifiers
Parent does not speak English or Spanish
Trial population
Parents (defined broadly to include a range of caregivers) of young children (2-5 years old) in Head Start programs in urban and rural communities in Maryland.
Trial design
Ecologic or community
Prospective
Treatments tested in this trial
Chicago Parent Program - individualized for families (CPPi)
BehavioralCPPi is a 8-12 session individual- based parenting skills program
Treatment groups
Trial outcomes
Primary outcomes
Change in Child Social - Emotional and Behavioral Wellbeing as assessed by the Strength & Difficulties Questionnaire (SDQ)
Strength \& Difficulties Questionnaire (SDQ), a 25 item measure of children's emotional symptoms (5 items), conduct problems (5 items), hyperactivity/inattention (5 items), peer relationship problems (5 items) and prosocial behavior (5 items). A higher score on the SDQ's emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems scales generally indicates more difficulties in those areas, while a lower score suggests fewer problems. Conversely, a higher score on the prosocial behavior scales indicates more positive social behaviors, while a lower score suggests more difficulties in this area. The score range for total difficulties is 0-40 and the score range for prosocial behavior is 0-10.
Change in Child Anxiety as assessed by the Preschool Anxiety Scale (PAS)
Preschool Anxiety Scale (PAS), a 28-item measure of young children's generalized, social, and separation anxieties; obsessive compulsive disorder, and physical injury fears. The score ranges from 0 - 112. Elevated scores on specific subscales may be indicative of potential concerns in those areas.
Change in Child Social - Emotional and Behavioral Wellbeing in the Classroom as assessed by the Social Competence and Behavior Evaluation (SCBE)
Head Start teacher ratings of children's social competence and behavior in the classroom using the Social Competence and Behavior Evaluation (SCBE), a 30-item measure with 3 subscales measuring children's social competence, anger/aggression, and anxiety/withdrawal. The score ranges from 30-180. A higher score on the social competence subscale suggests that the child displays more positive social behaviors and skills. A higher score on the anger/aggression subscale suggests that the child exhibits more anger and aggressive behaviors. A higher score on the anxiety/withdrawal subscale suggests that the child experiences more anxiety and withdrawal behaviors.
Change in parenting skills as assessed by the Parenting Questionnaire (PQ)
Parenting Questionnaire (PQ) is a validated 40-item measure of parents' use of positive discipline, harsh discipline, and consistency of discipline techniques. The score ranges from 40-200. There are 3 subscales of interest for the parenting questionnaire that include: (1) Warmth: higher scores = greater warmth; (2) Corporal Punishment: higher scores = greater use of corporal punishment, and (3) Following Through on Discipline: higher scores = more likely to follow through on discipline.
Secondary outcomes
Change in parental mental health - anxiety as assessed by the Generalized Anxiety Disorder Scale (GAD-7)
Generalized Anxiety Disorder Scale (GAD-7) is a 7-item screening measure of generalized anxiety. The score ranges from 0-21. A score of 0-4: indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety.
Change in parental mental health - depressive symptoms as assessed by the Patient Health Questionnaire-Depression Scale (PHQ-8)
Patient Health Questionnaire-Depression Scale (PHQ-8) is a brief measure of depressive symptoms in the general population. The score ranges 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Rita & Alex Hillman Foundation
Collaborator
Richman Foundation
Collaborator
Sherman Family Foundation
Collaborator
Blanket Fort Foundation
Collaborator
Wright Family Foundation
Collaborator
Abell Foundation
Collaborator
Baltimore Community Foundation
Collaborator