Clinical Research Directory

Digital Therapeutics for Behavior Problems

In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted app), or Group 3 (control app).

Strengthening Child Social-Emotional and Lifestyle Health in Families Experiencing Stress

This study evaluates feasibility and preliminary efficacy of a parent-based prevention program to promote social-emotional and lifestyle behavior health among 3- to 9-year-old children in families experiencing major stressors.

Parenting in the Preschool System in Malaysia

This study aims to evaluate the effectiveness of a hybrid human-digital playful parenting programme, "Naungan Kasih-Hybrid (NK-Hybrid)", in Malaysia. The programme is facilitated by teachers from Malaysian preschools for low-income families, consisting of a) one in-person session to introduce caregivers to the programme, b) teacher-facilitated WhatsApp support groups, and c) an interactive chatbot-led parenting programme featured on WhatsApp, called "Naungan Kasih-Text (NKText)". It tests the effectiveness of this package in a cluster-randomised trial, with 50 preschools as clusters, randomly assigned to either the treatment group or a waitlist control group. Findings from this study will provide evidence for the effectiveness of a low-cost and scalable intervention integrating digital modalities with a "light-touch" in-person component to improve educational outcomes in children attending preschools for low-income families, and thereby address social inequalities in Malaysia. N = 50 Clusters, 772 Primary Caregivers, 304 Secondary Caregivers, and 754 Children. Enrolment reflects participating primary caregivers.

The Effectiveness of a Classroom-based Intervention Promoting a Prosocial Classroom Climate in Children

The purpose of this study is to investigate whether a classroom-based program promoting a prosocial classroom climate is more effective than treatment-as-usual (control condition).

Southampton Women's Survey

The Southampton Women's Survey was established to assess the influence of factors operating before conception and during pregnancy on the health and development of the offspring. 12,583 non-pregnant young women were recruited, and 3,158 were followed through pregnancy, with their offspring followed-up at 6 months and 1, 2, 3, 4, 6-7, 8-9 and 12-13 years. The 17-19 year follow-up has been piloted and is about to start.

HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity

Parents are children's primary role models, are food and physical activity gatekeepers, and create the structure/lifestyle environment within the home. Thus, parents strongly influence children's weight-related behaviors and have the opportunity to cultivate a "culture of health" within the home. Yet, there continues to be a dearth of evidence-based obesity prevention intervention programs, especially for families with children aged 6 to 11 years, commonly called the middle childhood years. The aim of the HomeStyles-2 online learning mode RCT is to determine whether this novel, age-appropriate, family intervention enables and motivates parents to shape their home environments and weight-related lifestyle practices (i.e., diet, exercise, sleep) to be more supportive of optimal health and reduced risk of obesity in their middle childhood youth more than those in the control condition. The RCT will include the experimental group and an attention control group who will engage in a bona fide concurrent treatment different in subject matter but equal in nonspecific treatment effects. The participants will be families with school-age children who are systematically randomly assigned by computer to study condition. The HomeStyles intervention is predicated on the social cognitive theory and a social ecological framework. The RCT will collect sociodemographic characteristics of the participant, child, and partner/spouse; child and parent health status; parent weight-related cognitions; weight-related behaviors of the parent and child; and weight-related characteristics of the home environment. Enrollment for this study will begin mid-2021.This paper describes these aspects of the HomeStyles-2 intervention: rationale; sample eligibility criteria and recruitment; study design; experimental group intervention theoretical and philosophical underpinnings, structure, content, and development process; attention control intervention; survey instrument development and components; outcome measures; and planned analyses.

Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?

The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients. The main questions it aims to answer are: * Does the presence of a certified therapy dog during dental procedure requiring an injection reduce anxiety and improve behavior in pediatric dental patients? * How do the parents of pediatric dental patients who participate in the study view the use of a certified therapy dog in their child's treatment? * Does the presence of a certified therapy dog result in different concentrations of microbes in the treatment room? All participants will receive standard of care. Researchers will compare the group with a therapy dog present to a group who does not have a therapy dog present to see if heart rate, oxygen saturation, percentage of nitrous oxide administered, and Frankl scores differ between the groups.

Rehabilitation Training Games for Children With Amblyopia

A gamification product was developed to guide children with amblyopia to develop rehabilitation training habits by combining cognitive evaluation theory and occlusion therapy. A randomized controlled trial was conducted to examine the ease of use, acceptability and treatment compliance of the game.

Brief Interventions to Improve Behavior Outcomes and Prevent Cavities

The investigators will study brief educational interventions designed to address childhood behavior problems and prevent cavities.

Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers

Children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This project will systematically adapt an evidence-based parent training intervention to increase its acceptability and relevance for parents of young DHH children. Effectiveness of the adapted intervention and its implementation with parents of young DHH children followed in "real world" hearing healthcare clinics will be assessed.

Storybook and Animation Video Adjuncts to Tell-Show-Do in Pediatric Dentistry

This study is designed to evaluate strategies for reducing dental anxiety in pediatric patients. The commonly applied "Tell-Show-Do" method involves explaining and demonstrating dental procedures before they are performed. In this randomized controlled trial, three groups of children will be compared: Children who receive only the Tell-Show-Do method, Children who are prepared at home with a storybook prior to receiving the Tell-Show-Do method, Children who are prepared at home with an animation video prior to receiving the Tell-Show-Do method. Children's dental anxiety will be assessed using validated behavioral observation scales, including baseline measurement at the first examination, after preparation, and following completion of dental treatment. The study will determine whether the addition of a storybook or an animation video provides greater effectiveness in reducing dental anxiety compared with the Tell-Show-Do method alone.

Delivering Evidence-Based Parenting Services to Families in Child Welfare Using Telehealth

The goal of this randomized controlled trial is to compare Promoting First Relationships - Home Visit (PFR-HV) to Promoting First Relationships - Telehealth (PFR-T) among parents of 6-12 month olds in the child welfare system. The main questions it aims to answer are: * Is PFR-T effective relative to PFR-HV and Usual Care with respect to observed parent sensitive and responsive care, parent knowledge of child social and emotional development, and child externalizing behavior? * Is PFR-T effective relative to PFR-HV and Usual Care with respect to child out-of-home placement in foster care relative to the control group? * How does PFR-T compare in a benefit-cost analysis to the cost-effectiveness relative to PFR-HV and Usual Care? * Are eligible families impacted by the lack of technology and Wi-Fi/cellular data to engage in PFR-T? * How does provider adherence and fidelity in delivery of PFR-T compare to adherence and fidelity of PFR-HV? What will participants be asked to do? 1. Participants will be asked to agree to randomization, resulting in their placement in one of three groups: PFR-HV, PFR-T, or the control group. 2. Participants will be asked to participate in three virtual research visits, over the course of approximately 12 months (families could be finished as early as 9 months, however in our experience, intervention sessions and research visits often need to be rescheduled, delaying completion of the study). The research visits take approximately 80 minutes, and families will be paid $75 for each visit they participate in. 3. During the research visit, the families will be asked to participate in videotaped research activities involving parent-child play and interaction. Parents will be asked to answer questions regarding their background, feelings, parenting opinions, and stress. 4. Families randomized to the PFR-HV intervention are asked to participate in a 10 week in home parenting program which includes videotaped caregiver-child interactions and feedback. 5. Families randomized to the PFR-T intervention are asked to participate in a 10-week parenting program that will occur over Zoom, which will include videotaped caregiver-child interactions and feedback. 6. Families randomized to the control group will be emailed a resource packet with some information about services or programs that might be helpful for them.

Dental-Child Interaction Training

The goal of this behavioral, interventional clinical trial is to provide a specialized workshop training for dental providers (e.g., dentists, hygienists, assistants) to improve interactions with young children (2-10 years old) and parents/caregivers. The training is derived from a well-established behavior management program for preschoolers, Parent-Child Interaction Therapy (PCIT). The main questions it aims to answer are: * Change in behavior of dental providers * Acceptability of training by dental providers All participants will receive the same behavior training; however, one group will receive the training on a delayed schedule. Researchers will compare the immediate intervention and control group to see if the training was effective in the dental providers usage of skills.

Talk Parenting Education Program II

The goal of this clinical trial is to learn whether Talk Parenting, a voice-based program delivered through an Amazon Echo Dot (Alexa), can help parents and caregivers of children ages 3-5 years improve challenging bedtime and morning routines. The main questions it aims to answer are: Does using Talk Parenting improve families' bedtime and morning experiences and children's sleep/wake habits? Does using Talk Parenting improve parents' routine-related parenting practices and confidence, strengthen the parent-child relationship, and reduce children's behavior problems and parents' stress? Researchers will compare families who receive Talk Parenting right away to families who wait 6 weeks to receive the program (a waitlist control group receiving usual services during the wait). Participants will: Complete online questionnaires at the start of the study and again about 6 weeks later (and a follow-up questionnaire later in the study). Receive a pre-configured Amazon Echo Dot (to keep) and instructions to use Talk Parenting routines at home, including a bedtime routine, a brief calming routine, and a morning routine (enabled after the first 2 weeks).

Natural Helpers and PCIT

The purpose of the study is to evaluate the effect of a time-limited (i.e., 18 weeks) community health worker (CHW) intervention, referred to as the Parent Child Interaction Therapy (PCIT) plus natural helper (NH) model, on treatment engagement, retention, and child and caregiver outcomes.

Catholic Health Initiatives (CHI) St. Joseph's Children Home Visiting Longitudinal Study

This study involves a long-term outcome study of the Catholic Health Initiative St. Joseph's Children (CHI SJC) program using a randomized control study. The purpose of this study is to determine the short-term and long-term impact and effectiveness of the CHI SJC program. The CHI SJC program has not been studied to determine program effectiveness. The investigators intend to follow families and their children until the children in the study graduate from high-school or turn 19 years of age. The study, as a template, uses the eight outcome domains listed and described in the Home Visiting Evidence of Effectiveness website (http://homvee.acf.hhs.gov/outcomes.aspx). These eight domains are: * Child development and school readiness * Family economic self-sufficiency * Maternal health * Reductions in child maltreatment * Child health * Linkages and referrals * Positive parenting practices * Reductions in juvenile delinquency, family violence, and crime The investigators expect to observe significant differences among the two groups with respect to the primary outcome domains listed. The investigators expect study group members randomized to the CHI SJC program will perform better on the eight outcome domains. Other hypotheses include: Other Hypotheses: Hypothesis 1. Randomization to CHI SJC will be associated with higher quality functioning and better child health and well-being. Hypothesis 2. Randomization to CHI SJC will result in more connections to community resources. Hypothesis 3. Randomization to CHI SJC will result in improved indications of maternal health and positive parenting practices. Hypothesis 4. Randomization to CHI SJC will be associated with higher measures of family economic self-sufficiency. Hypothesis 5. Randomization to CHI SJC will be associated with increased school readiness and school progress and attainment. Hypothesis 6. Randomization to CHI SJC will be associated with reductions in juvenile delinquency, family violence, and crime. The study will collect outcome data in the same way and, at the same time, from treatment and control group members. Data collection will primarily be comprised of a set of self-report questionnaires and a review of administrative records that target the outcome domains described earlier. Study group members will be assessed at baseline, 6 months, 12 months, 18 months, 24 months, 3 years, 5 years, 8 years, 12 years, 15 years, and at high-school graduation or 19 years of age.

Self-Concept Reinforcement for Early School Readiness

The goal of this pilot randomized controlled trial is to evaluate a self-concept intervention (Self-Concept Reinforcement for Early School Readiness (SCR4ESR)) in young African American children using experimental and mixed methods. SCR4ESR provides self-concept themed children's books and advice at health supervision visits of children enrolled at ages 2-4 years. The specific aims of the proposed project are to: 1. assess the feasibility and acceptability of SCR4ESR implementation among parents and providers, 2. evaluate the capacity of SCR4ESR to improve self-concept reinforcement and book-sharing behaviors in parents of young African American children, and 3) evaluate the capacity of SCR4ESR to improve behavioral health and literacy in young African American children. The interviews conducted in Aim 1 will guide refinement of the intervention tested in Aims 2 and 3. The qualitative assessment will be complemented by quantitative trial statistics (e.g., recruitment rate) that inform trial feasibility and acceptability. Finally, the mechanism by which SCR4ESR impacts the primary outcome, behavioral health, and the secondary outcome, literacy, will be evaluated by structural equation modeling. This project will inform the development and implementation of early childhood interventions that improve the health of African Americans.

CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood

Disparities in health begin in early childhood. Early life experiences influence brain development and have significant implications on future health and developmental outcomes. Low-income children are at greater risk of developmental delays in large part due to a lack of an enriched environment. Disparities in early childhood development increase risk for stunted academic achievement throughout the life course. Primary care is a universal exposure in early childhood and therefore is also a significant entry point for promoting optimal child development. There is a need to provide effective, low-cost, and scalable interventions in primary care to support early childhood development.The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. To date, there is no evidence of the benefits of the CenteringParenting intervention on school readiness, or improvements in parental behaviors that support optimal developmental milestones and achievement. The intent of this study is to determine the effectiveness of the CenteringParenting intervention on school readiness in early childhood, as measured by language development at 24 months, (in addition to health care utilization, child routine care maintenance, parenting stress, caregiver behaviors and attitudes).

Effect of Sleep Extension on Body Weight and Learning in Children (More2Sleep)

More2Sleep is a randomized, controlled, parallel trial with two groups (sleep extension vs control) including 142 school-aged children (6-12 years) who have a BMI above average, defined as age- and sex-specific BMI Z-score above zero using WHO reference standards, and habitually sleep for ≤ 9 h/night. Data will be collected before and after a 3-month sleep extension intervention, and after a 6-month follow-up (at months 0, 3, and 9). The collection of data is mainly related to the main study. However, some optional examinations will be conducted on a first come, first serve basis, consisting of substudy-I (metabolic mechanisms, n=60) and substudy-II (learning mechanisms, n=142). The primary objective is to assess the effects of sleep extension by \~45 min/night, achieved by going to bed 60-90 min earlier, on adiposity and learning ability in school-aged children who have a BMI for age and sex above average, and sleep less than recommended for their age.

Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens

The goal of this clinical trial is to learn if the novel Dialogue Based Early Detection (DBED) method can prevent impaired mental health in kindergarten children. It will also learn about the screening properties of DBED to identify children with impaired mental health, if DBED facilitates early interventions, and if DBED is well accepted and sustainable in an ordinary kindergarten setting. The main questions it aims to answer are: * Do children in kindergartens where DBED is implemented develop better mental health scores than children in kindergarten where DBED is not implemented? * How well identifies DBED kindergarten children with impaired mental health compared to a traditional screening instrument (the Strengths and Difficulties Questionnaire)? * What is the impact of DBED on activation of interventions for mental health problems? * What is the social validity of DBED? Researchers will compare outcomes in kindergartens where DBED is implemented with outcomes in kindergartens where it's not. * During the last three years of kindergarten attendance participants (parents of kindergarten children) in the intervention kindergartens will take part in the biannual DBED parent-teacher meetings, while participants in the control kindergartens will take part in traditional parent-teacher meetings. * Twice a year all participants will answer questionnaires of the child's mental health and parental stress during the follow-up period (3 years in kindergarten and 2 first years in school). * Participants in the intervention kindergartens will answer user satisfaction questionnaires after every parent-teacher meeting. * The kindergarten teachers will report on type and time of supportive interventions for each participating child during the follow-up period in kindergarten.

Tele-Wellness Supported App for Family Child Care Home Providers and Families to Promote Health, Family Engagement, and School Readiness Amid COVID-19

The investigators aim to deliver a tele-wellness supported app to Baltimore City's Family Child Care Home (FCCH) providers who are caring for children of Essential Personnel. Once a pre-survey is conducted, login information will be assigned to 30 Family Child Care Home providers and parents the FCCH serve. Providers and Parents will receive self-care and parenting/parent engagement support through the app and through a tele-wellness service, Ask a Nurse, provided by community health nurses at the Johns Hopkins School of Nursing. Children will have access to gamified learning materials in early literacy, math, social-emotional learning, and nutrition.

Project PEAK: Early Intervention for ADHD

Parent education is an effective and relatively cost efficient approach for reducing child behavior problems. Research, however, suggests that the effectiveness of parent education is mitigated by parent attendance and parent implementation of intervention strategies. That is, low attendance at parent education sessions is associated with limited intervention effects. Therefore, it is critical to identify strategies to enhance parent engagement. A previous pilot randomized controlled trial of a parent education program (Behavioral Parent Education; BPE, specifically Promoting Engagement for ADHD pre-Kindergartners \[PEAK\]), found that both face-to-face (F2F) and online BPE resulted in high levels of parent engagement and child behavior improvements. However, results need to be replicated in a full scale efficacy trial with a larger, diverse sample to provide more reliable estimates of relative effect sizes for parent and child outcomes and to evaluate the extent to which parent and child behavior changes are maintained after BPE has ended. In the current randomized controlled trial, the investigators intend to apply What Works Clearinghouse group design standards to examine the efficacy of two forms of delivery of BPE (F2F and online) relative to a wait-list control condition in a sample of 180, 3- to 5-year old children with clinically significant symptoms of ADHD. The objective is to: (a) extend findings from the pilot investigation to a large, diverse sample; (b) examine maintenance of effects; (c) identify moderators and mediators of treatment outcome, especially the degree to which these may differ for F2F vs. online treatment delivery; and (d) assess cost and cost-effectiveness of the two PEAK delivery formats.

Teachers Leading the Front Lines - North Carolina (Tealeaf-NC)

Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted child mental health care. Participants: \~300 estimated Procedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods, clustered evaluation of Tealeaf-NC's Reach, Adoption \& Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness \& Maintenance (Secondary Outcomes, clinically-based).

Agile Development of a Digital Exposure Treatment for Youth With Chronic Musculoskeletal Pain

This project proposes to systematically develop and evaluate the feasibility and preliminary effectiveness of a digitally delivered, graded exposure treatment for youth with chronic musculoskeletal pain, utilizing a sequential replicated and randomized single-case experimental design (SCED). SCED provides the opportunity to rigorously evaluate treatment effectiveness at the individual level. Development of iGET Living will be based on a series of short iterations, with alpha testing (Aim 1) on a small sample of adolescents with chronic pain (N = 15). For Aim 1, participants will participate in three, two hour focus groups (one per week over the course of three weeks), resulting in 6 total hours of participation per participant for Aim 1. Aim 2 will involve a sample (N = 20 youth) of naïve end-users. Participants will be enrolled in a baseline period ranging from 7-25 days (done to support SCED methodology) after which they will be enrolled in the online intervention program, lasting 6-weeks. Patients will be contacted 3-months post-discharge from treatment (week 22 of enrollment) and will complete self-report outcome measures at this time.