Clinical Research Directory

Positive Parenting Program in Foster Care

The purpose of the study is to evaluate early implementation outcomes of a positive parenting program, Child Adult Relationship Enhancement in Primary Care (PriCARE), in the foster care setting and to assess the efficacy of PriCARE in promoting positive parenting and increasing empathy among foster caregivers.

Step-by-Step: Evaluation of a Stepped Care Model

The primary aim of this project is to examine the effectiveness of a stepped care model of interventions for children's defiant or aggressive behavior problems. The stepped model consists of a brief internet-based parenting support program (Step 1). For those with continued need of additional interventions, Step 2 includes access to one of following interventions: b) a Cognitive Behavior Therapy (CBT) -Virtual Reality (VR)-assisted parenting support program, b) a Cognitive Behavior Therapy -Virtual Reality-assisted child intervention, or c) standard interventions/support at the family's unit/clinic and continued access to the study's internet-based parenting support program, after which the family may choose CBT-VR for the child or the parent.

Family STEPS: Family Check-Up+

Interventions that promote safe, stable, and nurturing relationships between caregivers and children are key to improving healthy family relationships, reducing child socioemotional and behaviour problems, and preventing child maltreatment. Although a broad range of parenting programs are currently implemented in communities across Ontario, most programs are inadequately evaluated, or else not evaluated at all using a pilot pragmatic Hybrid Type II individually randomized controlled trial conducted within routine service settings. The trial will enroll 300 families in Ontario, Canada. The evaluation is informed by the RE-AIM framework, with a primary emphasis on Reach and Implementation and secondary examination of Effectiveness, consistent with the objectives of a Hybrid Type II design.

I-InTERACT Preterm Parenting

Many children born very preterm experience behavior problems, and existing resources for parenting these children are lacking. A pilot trial established the effectiveness of a preterm parenting intervention, I-Interact Preterm (I2P). This study proposes a three-arm randomized controlled trial (RCT) comparing the established seven-session I2P program, a microlearning delivery mode (I2P-Micro), and an internet resource comparison group (IRC). Outcomes will be assessed at pretreatment, post-treatment (12 weeks later), and at an extended follow-up six months post-randomization. These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in significant improvements relative to the IRC condition, with greater utilization expected in the I2P-Micro group.

SKIP for PA Study: Team and Leadership Level Implementation Support for Collaborative Care

In a prior application (MH064372), the investigators' treatment research program (Services for Kids In Primary-care, SKIP) developed and tested a chronic care model-based intervention, called Doctor Office Collaborative Care (DOCC), that was found to be effective in the management of childhood behavior problems and comorbid ADHD. In the "SKIP for PA Study", the investigators propose to conduct a randomized clinical trial to evaluate the effects of team- and practice leadership-level implementation strategies designed to enhance the use and uptake of DOCC in diverse pediatric primary care offices.

Resilience Through Interventions for Successful Early Outcomes

Purpose: The purpose of this research is to determine the effects of Attachment and Biobehavioral Catch-up (ABC), an evidence-based parenting program, on stress biomarkers in children. Participants: The study will involve approximately 150 caregiver-child dyads, with children aged between 24 and 42 months. Participants will include primary caregivers fluent in English or Spanish, along with their children who have experienced social risk factors for adversity. Procedures (Methods): Participants will be randomly assigned to either receive the ABC parenting program (10 sessions) immediately or be placed on a wait-list, receiving the program after about 4 months. The study procedures include caregivers completing online surveys, engaging in play-based observational tasks with their children, and collecting non-invasive biological samples (saliva, cheek swab, hair) from the children and saliva samples from the caregivers at 2-3 time-points.

Improving Outcomes in Social Services Through Routine Outcome Monitoring and Systematic Client Feedback

In this project the investigators want to test whether a new method FIT (Feedback informed treatment) can improve the interventions people receive through social services. The FIT method involves regularly providing information about how the client think things are going and what the client thinks about the help and care they receive.

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.

The Pittsburgh Study Early Childhood

The Early Childhood Collaborative of The Pittsburgh Study is a community-partnered, county-wide implementation of programs for children and families from birth through formal school entry to address real-world challenges that exist in providing effective preventive interventions for families with young children, particularly low-income families.

Implementing Dyadic Developmental Psychotherapy (DDP) - Evaluation Research

The objective of this study is to evaluate the implementation and use of Dyadic Developmental Psychotherapy (DDP) in three centra, with particular focus on its potential effects on the quality of the observable caregiver-child interaction. The three centra included are Telemark Hospital Trust, Department for Child- and Adolescent Psychiatric Health, Child Protective Services in Skien and Child Protective Services in Porsgrunn. The implementation of DDP is being led by Telemark Hospital Trust, while therapists from all centra are being trained in DDP as part of the implementation process. Primarily we aim to identify any changes associated with DDP treatment in the caregiver-child interaction, as measured by the Emotional Availability Scales (EA scales). Our secondary outcome measures assess changes in parental self-efficacy, parental stress, and child emotional and behavioral problems. The research aims are divided in three research questions: Q1: What changes are associated with DDP treatment: Q1.1 the quality of the caregiver-child interaction Q1.2 parental self-efficacy Q1.3 parental stress, Q1.4 child emotional and behavioral problems Based on previous literature, we hypothesize that we will see an increase in the quality of the caregiver-child interaction and parental self-efficacy after completing the DDP treatment, and a decrease in parental stress and child emotional and behavioral problems (Becker-Weidman, A. 2006) In addition to assessing the effects of DDP we will evaluate the implementation of DDP in the three centra, and inform the implementation by collecting information through interviews with patients and clinicians. We aim to answer: Q2: How do children and their caregivers experience DDP as a therapeutic intervention? Q3: How do clinicians experience the training process and the use of DDP as a therapeutic intervention? Based on previous literature, we hypothesize that we will see an increase in the quality of the caregiver-child interaction and parental self-efficacy after completing the DDP treatment, and a decrease in parental stress and child emotional and behavioral problems

Multi-level Child Mental Health Interventions in Azerbaijan

To improve mental health outcomes among children aged 7-14 from low-income families in Azerbaijan, this study will refine and test three evidence-based intervention approaches: family-strengthening intervention; trauma-focused mental health services; and economic empowerment in the form of Child Savings Accounts. Based on prior research on the mental health of deinstitutionalized children conducted by this U.S.-Azerbaijani team in collaboration with a local Community Collaborative Board, these intervention components have been adapted to maximize fit to the cultural context of Azerbaijan. In this study, the adapted interventions will be tested with 600 child-caregiver dyads in a trial using the Multiphase Optimization Strategy (MOST) to compare different intervention components and identify the most optimal combination. Given the limited human and financial resources in low- and middle-income countries (LMICs), it will be important to identify whether each of these interventions is necessary and/or sufficient for improving the mental health of children. The study will test the effects of each intervention component on children's mental health outcomes (symptoms of depression, anxiety; disruptive behaviors; post-traumatic symptoms;), on associated cognitive and social processes (e.g., attention, emotion recognition bias) and functional outcomes (e.g., academic performance). The study will also examine the mediating pathway associated with each intervention component.

Strong Mother Strong Special Individual

Special needs individuals with mental disabilities and other special conditions accompanying mental needs (hearing disability, visual disability, physical disability, autism spectrum disorder, multiple disabilities, language and speech disorder, learning disability and emotional/behavioral disorder) are diagnosed with special needs individuals. It includes mothers who are in service. Caregivers of children with mental special needs may experience mental problems such as anxiety, hopelessness and depression, which negatively affects the caregiver's mental resilience and increases their care burden. In order to reduce the care burden, artistic activities will be organized to express the emotions of caregivers.

Pilot Study of Parent Training With Role-plays in Virtual Reality for Parents of Children With Behavior Problems

The main aim of this pilot trial is to evaluate preliminary effects and feasibility of a new parent training program for parents of children aged 8-16 years with disruptive behavior (e.g., angry, aggressive or defiant behavior). The parent training program is based on cognitive behavioral therapy (CBT) and includes practicing of skills in virtual reality (VR). The main questions the project aims to answer are: * What are the preliminary effects of the CBT-VR parent training program? * What is the level of parent engagement in the CBT-VR parent training program? * What are the experiences of parents and therapists of the CBT-VR parent training program? The CBT-VR parenting program is delivered at clinics during individual sessions. Parents will answer quantitative measurements before, during, and after treatment. Within-group analyses will be conducted to examine experiences and preliminary effects of the program. Parents and clinicians are also asked to participate in a qualitative interview after the program has ended.

Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Behavior Problems

The main aim of this small pilot trial is to evaluate preliminary effects and feasibility of the child intervention YourSkills for child disruptive behavior (e.g., enhanced anger or aggressive behavior) when evaluated in Sweden for children/youth aged 10-16 years. YourSkills is based on cognitive behavioral therapy (CBT) and includes practicing of skills in virtual reality (VR). The main questions the project aims to answer are: * What are the preliminary effects of the child/youth CBT-VR-program? * What is the level of child/youth engagement in the CBT-VR program? * What are the experiences of parents, children/youth and therapists of the program? The CBT-VR program is delivered at clinics during ten individual sessions. Parents will answer quantitative measurements before and after treatment, children will answer quantitative measurements before, during and after treatment. Within- group analyses will be conducted to examine experiences and preliminary effects of the program. Parents, children and clinicians are also asked to participate in a qualitative interview after the program has ended.