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50 active trials for Parent-Child Relations

MIO-CPP to Improve the Well-being, Permanency, and Safety Outcomes for Young Children at Risk of or in Out-of-home Placement in Philadelphia and Bucks Counties, and Affected by Maternal Substance Use

The purpose of the study is to evaluate the efficacy of a novel mother-child therapeutic model called MIO-CPP compared to CPP-only. The goal of MIO-CPP is to improve child well-being, permanency and safety, and reduce the risk for involvement in the child welfare system for children pre-birth to five who are affected by parental substance use disorders (SUD) and/or other mental health problems. The goal of the project is to improve child well-being, permanency and safety, and reduce the risk for involvement in the child welfare system for families with children pre-birth to five who are affected by parental substance use disorders (SUD) and/or other mental health problems. The project will integrate with SUD treatment programs for pregnant/parenting women and their children by providing two evidence based therapeutic models, Mothering from the Inside Out (MIO) and Child Parent Psychotherapy (CPP). MIO and CPP will promote the development of parental reflective functioning and strengthen parent/child attachment. The study will use a randomized control trial to test the effectiveness of MIO and CPP together (intervention) compared to CPP alone (controlled) on parent/caregiver well-being, child well-being, and family well-being. The study will assess and compare parental satisfaction as well as explore whether demographics, history of DHS involvement, and substance use treatment history affect the outcomes. MIO is an individual, 12-session, manualized, psychotherapeutic intervention. CPP is typically offered through weekly sessions with the mother-child dyad that last 1 to 1.5 hours. The MIO-CPP (intervention) model lasts 9 months and will begin with the standard 12 weeks of MIO for each mother, with the CPP assessment and engagement phase embedded during this time. This will be followed by the dyadic mother-child phase, the core intervention stage of CPP. The CPP (control) model will last for 9 months. The recruitment for study participants will stop when 170 mother-child dyads have enrolled in the study. Participants will be recruited from three substance use treatment facilities in Philadelphia and Bucks Counties: Caring Together at Drexel University, Interim House West, and Libertae, Inc. Data collection from participants will occur at four time points during the study: 1) when participants are enrolled; 2) 3 months following enrollment; 3) 6 months following enrollment; and 4) 9 months following enrollment or when the participant ends their participation in weekly therapy sessions if sooner than 9 months following enrollment. Study measures will include: 1) Parent/Caregiver Well-being: a) maternal reflective functioning, b) depression, anxiety, and trauma-related symptoms, c) parental substance use and move toward recovery; d) parenting stress; e) parent-child relationship; 2) Child Well-being: a) behavior problems, b) executive functions; c) socialization skills; 3) Family Well-being: a) child welfare involvement, b) reunifications. As part of this study, investigator will acquire administrative data about the safety and permanency of children and adult recovery for all study participants. The Primary Investigator will request substance use treatment data from the City of Philadelphia Department of Human Services, and Department of Behavioral Health and Department of Behavioral Health and Intellectual disAbilities. The requested data elements will include whether the study child has a child welfare record, the types of allegations of abuse or neglect, and when the allegations occurred (from birth to present day). Additionally, investigators will request all available substance use treatment records will be requested for adults who are a part of a study case for the year prior to enrollment in the study to one year following their enrollment in the study.

Start: January 2020
Video Feedback to Improve Parental Sensitivity in Mother-infant Dyads With Depressive Symptoms

Title: "Internet mentalization-based video feedback intervention to improve parental sensitivity in mother-infant dyads with maternal depressive symptoms: randomized controlled feasibility trial". Funding: ANID Millennium Science Initiative /Millennium Institute for Research on Depression and Personality-MIDAP ICS13_005 (MIDAP, www.midap.org). Principal Investigator: Marcia Olhaberry Huber, PhD, Academic, School of Psychology, Pontificia Universidad Católica de Chile, Associate Researcher, MIDAP. MIDAP Research Team: Javier Moran, PhD. Academic at the University of Valparaíso, María José León, PhD, Stefanella Costa, PhD. and Fanny Leyton, PhD. (c) University of Valparaíso. General Objective: To evaluate feasibility and acceptability of a brief Internet mentalization-based video feedback intervention to improve sensitivity in mothers with depressive symptoms. Key parameters for a future effectiveness study will be identified Design: Pilot randomized clinical trial; Participants: 60 mother-infant dyads (aged 4-12 months) attended in Public Health Centres.30 dyads will be assigned to the experimental group (EG) and will receive a weekly online brief intervention using video-feedback and psycho-educational materials on early parenting. 30 dyads will be assigned to the control group (CG) and will receive only psycho-educational materials. The study includes 3 assessments (pre-intervention, post-intervention and follow-up) and four weekly intervention sessions. Data analysis: For quantitative data descriptive statistics and ANCOVA will be used, for qualitative data Grounded Theory.

Start: March 2021
ATTACH™ Program: Promoting Vulnerable Children's Health at Scale

ATTACH™ is a psycho-educational parenting program, designed with community agencies serving families of preschoolers affected by toxic stress (e.g. parental depression, addictions, domestic violence, poverty) to bolster children's health and development. It focuses on improving parent-child relationship quality by targeting parents' reflective function (RF), i.e. the ability to better understand one's own and one's child's thoughts and feelings. RF is essential for high quality parent-child relationships and secure attachment, both tied to child development and health, especially cognition, communication and inflammation. ATTACH™ was implemented and tested in seven rapid-cycling pilot studies by researchers, guided by the IDEAS (Innovate, Develop, Evaluate, Adapt, Scale) Framework™, an innovative clinical trial approach. ATTACH™ significantly improved: (a) parent-child relationship quality and attachment, (b) parents' RF scores, and (c) children's cognitive and motor development. However, whether ATTACH™ continues to work with delivery by trained agency healthcare professionals rather than study researchers, in naturalistic, community settings remains to be seen. Small sample sizes also limited the ability to assess longer-term impacts and whether ATTACH™ is equally effective across patient populations. Further, another parenting intervention successfully reduced systemic inflammation in children exposed to toxic stress. Whether ATTACH™ impacts novel biomarkers of inflammation (i.e. immune cell gene expression and DNA methylation) is not known.

Start: May 2021
Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China

Objectives The primary objective of this study is to evaluate the effectiveness of the SREIA parent training program for families of children with ASD aged three to six years in mainland China. The study will be conducted within the context of routine service provision and assess the effectiveness of SREIA in reducing child behavioral problems as measured by the Externalizing scale of the Child Behavior Checklist (CBCL) for Ages 1.5-5, in comparison to a waitlist control group. Secondary objectives include examining the effectiveness of the SREIA program in reducing ASD symptoms and improving parental and familial outcomes including parental knowledge of ASD and ABA techniques, parenting styles, parental mental health (including stress, anxiety and depression), and family functioning. A process evaluation will be conducted alongside the quasi-experimental trial, the objectives of which are to 1) describe the implementation aspects of the programs with regard to participant involvement, program acceptability, delivery, and sustainability; 2) explore predictors of participant involvement; and 3) examine potential relations between implementation aspects and treatment effects. Background ASD is associated with elevated levels of child emotional and behavior disturbance, which impair child daily functioning and impose challenges to parenting. The SREIA programme is a group-based parent training in China, that has been delivered since 1993 and reached over 10,000 families. However, there is an absence of scientific evaluations of programme effectiveness. This study aims to fill this evidence gap, and the findings will be used to inform future modification, replication, and dissemination of the programme in other parts of China. This study will also contribute to the literature on the effectiveness of parent training programmes for ASD and for families living in low- and middle-income countries. Methods A quasi-experimental design with a mixed-methods approach will be used, involving two consecutive waves of delivery of the SREIA programme. Parent participants will complete demographic and outcome questionnaires at baseline, immediate post-intervention, and 6-month post-intervention (conditional to funding). The implementation components will be assessed by collecting attendance and engagement registry data, facilitators filling out fidelity checklists, research staff observing programme sessions, and parents answering a satisfaction questionnaire. After the programme, some parents, facilitators, and NGO (non-governmental organisation) managers will be invited to take part in qualitative interviews or focus group discussions so as to explore their views about the programme, and to better understand the quantitative data obtained.

Start: September 2020
Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas

Incarcerated pregnant women are a largely invisible special population with great need for health care and advocacy. The number of women who are incarcerated in the U.S. has increased over 750%, or from 13,258 in 1980 to 111,616 in 2016. Arkansas has the 8th highest number of incarcerated women in the nation, 60% higher than the national average. As the number of incarcerated women has risen, so too has the need for jails and prisons to address women's health needs, including pregnancy, childbirth, and postpartum care. Nationally, over 75% of incarcerated women are of childbearing age and about are pregnant upon intake. However, little is known about the population of women who have become incarcerated while pregnant in Arkansas - including the outcomes of these women and their children and how these outcomes may vary in relation to services that are received during incarceration. This research study aims to first expand knowledge on incarcerated women in Arkansas by using administrative data to retrospectively examine the health status and outcomes of pregnant women who were incarcerated in state prison by Arkansas over a five-year period (Aim 1). Then, the investigators will lay the groundwork for and subsequently analyze prospectively gathered outcomes of women in Arkansas state prisons by supplementing administratively-collected data with in-person data collection (Aim 2). This prospectively-gathered data will include records of: 1) self-report responses to surveys about their health and mental health, 2) women's participation or nonparticipation in elements of programming for incarcerated pregnant women that was recently launched by Arkansas Department of Correction in collaboration with the study PI (i.e., Growing Together), and 3) self-report responses to surveys about the elements of Growing Together. The Growing Together program elements that are currently active and that will be evaluated under this protocol are a lactation program, lactation education, and a mental health support group. The investigators will also pilot and conduct an open-label evaluation of an additional program component, doula support, with a sample of up to 24 incarcerated women (Aim 3). Assessment of the program components in Aims 2 and 3 will focus on evaluating acceptability to the population and feasibility.

Start: July 2021