Clinical Research Directory

Implementation Study With Embedded RCT of a Digital System of Parenting Support Within Government Services in South Africa

ParentText, a WhatsApp-based parenting support programme, is designed as a universal intervention to improve parent-child relationships (module 1) and promote child safety (module 2). The SWIFT study is an explanatory sequential time series design with an embedded randomised controlled trial. The time-series design aims to assess whether a digital parenting support programme, ParentText, can be embedded effectively into the regular services offered by the Department of Health and Wellness in the Western Cape, South Africa, and to explore factors affecting parent engagement. The embedded randomised controlled trial tests whether the second module affects sexual violence reduction against children. Participants include caregivers 18 years and older, living in South Africa, and caring for at least one child aged 2 to 17 years. The primary outcome measures of the study are both implementation 1): Assessing which of four approaches to advertising the ParentText programme leads to the highest rates of programme uptake, engagement, and completion; and programmatic: Testing the effectiveness of the additional Child Safety Module in 2) - reducing child sexual violence vulnerability, 3) - increasing child sexual violence risk planning and 4) - reducing child sexual violence exposure. The secondary outcomes assess changes in programme users' self-reported parenting behaviour in terms of 1) positive involvement, 2) positive parenting, 3) parent mental health, 4) parent support of education, 5) caregiver child/ adolescent communication, 6) online safety, 7) harsh parenting, 8) child or adolescent behavioural problems; and assessing users' experience of the 9) accessibility of the chatbot, 10) acceptability of the chatbot; and 11) adolescents' report of their sexual violence risk and safety planning communication.. In the first period of the time series design, participants will be recruited via posters, which provide a WhatsApp number for the programme, at their local clinic. Once they join, they will be provided with information on the study and be invited to consent to participate. If they consent, they will complete a baseline survey and then be able to move on to the first 5-day module. On consent to the study, participants will be placed randomly into either the group that receives the second module (intervention group) or a control group that will receive the module only after the study is completed. Both the intervention group and the control group receive the one-month and three-month surveys. In the second, third, and fourth time periods, everything remains the same except the encouragement method. In the first time period, only posters were used for recruitment. Within the second period, one month later, recruitment will be via both posters and additional encouragement from clinic staff. Clinic staff will encourage either verbally or by providing the caregiver with a flyer during their clinic visit. Throughout both these recruitment periods (1) and (2), caregivers who have completed the programme can share it on social media by posting predesigned tiles that include the joining information for the chatbot. Should our ideal sample size (4,000 participants) not be reached through these mechanisms, there will be an additional time period (3-4 weeks; time period three) during which the study team will advertise directly on Facebook. Finally, should our sample size not be reached in this third period, there will be a fourth time period of advertising that offers ZAR50 (approximately USD3) in airtime to those who sign up. This ZAR50 will be provided in sums of: ZAR15 for completing each of the baseline and one-month questionnaires, and ZAR20 for completing the three-month questionnaire. Once the three-month questionnaires are completed, participants will also be invited to a focus group discussion or telephonic interviews. Participants will be purposively selected from the group of participants who consent to the qualitative data collection phase. The focus groups will be conducted with participants residing in the Western Cape province, who completed one or both modules, and will discuss topics such as their experience of the ParentText programme, and the encouragement. For the telephonic interviews, participants will be purposely selected for interviews, looking at a) caregivers' experience of the child safety module, b) reasons for engaging/not engaging with the programme, and c) which referral services they accessed. Further, adolescents (over the age of 12 years) will be recruited via their caregivers - upon completion of the 3-month survey, parents or legal guardians will be asked to provide consent for the team to contact their adolescent to undertake a telephonic survey and, in some cases, a qualitative interview with them. Teens will complete informed assent.

A Strength-based Parenting Program for Parents With Young Children From 3 to 6 Years Old

The parent education and family support component in phase 2 aims to strengthen protective factors of healthy child development and reduce risk factors of child abuse and neglect among disadvantaged families by providing community-based preventive interventions for children and their significant adults. Participants include about 600 parents from randomly assigned 100 preschools to the four groups (group 1: hub + school support; group 2: school support; group 3: hub support; group 4: delay group). The primary hypothesis is to examine the efficacy of the parenting programs for young children and their parents from K1 to K3. The programs are delivered by social workers at kindergartens or community hubs. The second aim/hypothesis of this project is to investigate the overall synergy impact of the community hub. The success of the parent-child interactive program offers a foundation for the hub to further develop community-based parent education and family support programs that aim at building parents/caregivers' competence in optimizing child development and competence in caregivers and professionals through networking multiple ecological systems, i.e., family, school, and hub or other organizations in the community.

Digital Behavioral Parenting Programs With and Without Added Emotion Regulation Strategies to Manage Anger in Parenting

This pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary effects of two digital parenting interventions for parents experiencing difficulties with anger in parenting. The interventions are internet-delivered adaptations of evidence-based parenting programs, collectively called the Supporting Healthier Interactions in Families by Online Tools (SHIFT) parenting programs. The main questions the study aims to answer are: 1. Are the study procedures and design feasible for a full-scale RCT? 2. Are the SHIFT parenting programs feasible and acceptable? 3. How do therapists and parents experience the SHIFT parenting programs? 4. Is participation in one of the SHIFT parenting programs, relative to the other and relative to waitlist control, associated with improvements in parent-reported intervention outcomes? 5. Is participation in the SHIFT parenting programs, relative to each other and waitlist control, associated with improvement in weekly measures of target mechanisms? Researchers will compare the two programs against each other and against a waitlist control. The first intervention (SHIFT) is a behavioral parent training (BPT) program with parenting strategies to manage child behavior problems. The second intervention (SHIFT+) includes the same BPT strategies with emotion regulation (ER) techniques from anger-management treatments. Participants will: * Be randomized to SHIFT, SHIFT+ or waitlist control. * Take part in one of the digital interventions and receive support in text messages and phone calls from a therapist at family support services in Swedish municipalities. Some participants will take part in the intervention after the waitlist period. * Respond to questionnaires and take part in interviews.

Early Test of an Innovative Child Maltreatment (CM) Prevention Strategy

Millions of children are victims of maltreatment each year in the United States. Research on home visiting programs show that child maltreatment can be prevented; however, these programs struggle to reach families in need and provide high quality care. SafeCare is a sustainable and effective home visiting child maltreatment prevention program, serving over 8,000 families each year. This study will examine the feasibility and implementation of a hybrid in-person/virtual delivery model for SafeCare with 12 home visiting providers and 40 caregivers to inform how home visiting programs are delivered to maximize reach to families, improve family outcomes, and decrease harm to children.

A Randomized Controlled Trial of the Efficacy of the Lighthouse Parenting Programme in Addressing Parenting Difficulties in China

The study will be conducted in three phases: assessments, group intervention and individual intervention. All participants will engage in the full program over a period of five weeks, divided into ten sessions. The 5 group interventions will occur once a week for 1.5 hours. During this time, the psychotherapist will disseminate psychological knowledge and skills pertinent to parenting, after which the group members will engage in practice exercises and discourse. Subsequently, one individual session will be conducted each week for one hour. The test group (Group A) will be assessed once at recruitment and after the last individual session. The control group (Group B) will undergo the same intervention as the test group after the test group completes the intervention and posttest, and will be assessed one additional time for pre-intervention status.

Effects of Enriched Parent-Infant Interaction on Health in Early Life

Early life experiences, such as those associated with stable attachment, supportive relationships, and nurturing environments, have profound effects on lifelong physical and mental health. However, children have very different levels of access to such experiences, depending on their family characteristics and associated risk and resilience factors. Low-cost interventions aimed at improving infant environments offer a promising avenue for reducing inequality in early experiences because they require minimal effort to implement. Previous work from the Music lab showed the promise of infant-directed vocalizations, especially music, for enriching parent-infant interaction. Such behaviors are cross-culturally universal, appear regularly in the context of infant care, and have robust effects on infant psychophysiology. In recently completed pilot work, it was found that a brief smartphone-based music intervention achieved high adherence and low attrition; led parents to increase their use of music in soothing their fussy infants; and improved infant mood, as reported via ecological momentary assessment (EMA). Together, these findings show the potential for enriched parent-infant interaction, particularly via infant-directed singing, to improve infant and parent health. Here, a Phase II randomized trial is proposed to explore such effects. Parent/infant dyads (N = 192, infant starting ages 0 to 4 months) will be randomly assigned to one of four conditions: (1) music with enrichment, where parents receive a smartphone-based intervention to learn to sing interactively with their infants, via the early childhood music program Music Together; (2) music with limited enrichment, where parents receive music recordings to listen to with their infants, but are not provided with enrichment activities; (3) enrichment with limited music, where parents receive books to read interactively with their infants, but are not provided with music activities; or (4) a no-treatment control. Throughout the 8-month study, a text-message-based EMA and a survey battery will be used to measure key health outcomes for both infants (distress and recovery, sleep quality, and mood) and parents (mood, mental health status, and parenting efficacy); potential moderators of such effects (demographics, family contextual factors, parent/infant attachment, and infant temperament); as well as parents' degree of engagement in the interventions. Effects will be analyzed both across the intervention groups and relative to the no-treatment control to determine the relative effects of each intervention. The results of this work will determine the effects of low-cost, low-effort early enrichment interventions on basic, everyday health outcomes for infants and parents, test the feasibility of app-based interventions and data collection tools (including in socio-economically disadvantaged families), and provide rich data on the daily lives (including mood, temperament, and sleep variables) of families with young infants. The findings will have particular relevance for underprivileged families and first-time parents, and will set the stage for larger-scale studies of early parent-infant enrichment.

Parent Training for Parents of Toddlers Born Very Premature:

The purpose of the study is to test the effects of the ezParent (web-based parent training program) intervention and telephone coaching calls (coach) on parent and child outcomes after 3-, 6-, and 12-months. Parents (n=220) will be randomized using a 2 x 2 factorial design to: (1) ezParent+coach, (2) ezParent, (3) Active Control+coach, or (4) Active control. The investigators will address these aims: 1. Determine the independent and combined effects of ezParent and coaching calls on parent outcomes. H1: The ezParent and ezParent+coach groups will report greater improvements in parenting skills and self-efficacy and reductions in harsh and negative discipline; and exhibit observed improvements in parent-child emotional connection vs. active control H2: There will be a synergistic effect of ezParent and coaching calls on parent outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls. 2. Determine the independent and combined effects of ezParent and coaching calls on child outcomes. H3: The ezParent and ezParent+coach groups will report greater reductions in child behavior problems vs. active control. H4: There will be a synergistic effect of ezParent and coaching calls on child outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls. 3. Determine differences in ezParent engagement with and without coaching calls. Engagement will be assessed by frequency (the number of times parents use the program), activity (proportion of material completed), and duration (amount of time parents use the program). H5: Relative to the ezParent only group, the ezParent+coach group will exhibit higher engagement with the ezParent.

The New Beginnings Podcast: Brief Audio Intervention for Parents From Divorced and Separated Families

The goal of this study is to learn if the New Beginnings Podcast can help children whose parents are going through a divorce or separation. The podcast shares parenting strategies that have been shown to help in past in-person and online programs. This study will also look at how easy it is for parents to use the podcast and how helpful they find it. The main questions it aims to answer are: 1. Do parents find the podcast easy to use, helpful, and relevant? 2. Does listening to the podcast improve children's mental health? 3. Does the podcast help parents build stronger relationships with their children and reduce conflict between parents? Researchers will compare families who use the podcast to families on a waitlist to see if the podcast makes a difference. Participants will: 1. Listen to podcast episodes over the course of the study 2. Answer questions about their experiences with the podcast 3. Complete surveys about their child's well-being, their parenting, and family relationships This study will include 80 parents and their children.

Resilient, Engaged, and Connected Study

Purpose of this study is to test the effectiveness and implementation of an evidence-based parenting intervention for improving parenting and school outcomes in a sample of 4-5-year-old children enrolled in public prekindergarten (PreK) programs in Maryland.

Amazing Start Parenting Program

Whether young children can develop healthily depends a lot on the family environment where they grow up in. Risk factors, such as low family income or health issues within the family, may pose threats to young children's development. To mitigate the effects of these risk factors, the research team has developed a community parenting program titled "Amazing Start", which aims to improve young children's well-being through the provision of parenting interventions to the families with known risk factors. The parenting interventions include one-to-one coaching on parent-child interactions as well as parent support groups that are led by social workers. This 2-year study aims to investigate the effectiveness and sustainability of the "Amazing Start" community parenting intervention program for at-risk families across three districts in Hong Kong using a randomized controlled trial. Participating families are randomized to either the experimental group, where parenting interventions are provided for a period of 9 months, or the wait-list control group, where no parenting intervention is provided during this 9-month period. Pre-test and post-test are conducted to assess the development of young children, as well as the parental stress, parental sense of competence, and parental satisfaction of the participating families. The wait-list control group receives the parenting intervention after the post-test.

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.

Parenting for Tomorrow: A New Model for Supporting Preschool Children's Mental Health in Head Start

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.

ATTACH in Denmark: A Feasibility Randomized Controlled Trial

The goal of this feasibility randomized controlled pilot trial is to learn whether the trial can be done as planned, and to investigate if the 10-session parenting program "ATTACH(TM) increases mentalizing skills (the ability to reflect on thoughts and feelings) in parents of children between 0-5 years of age, who are receiving support for psychosocial problems in their municipal family treatment center. The main questions the trial aims to answer are: * How many eligible parents agree to participate in the random allocation to treatment? * How many parents allocated to receive "ATTACH(TM) will have completed the program 5 months after allocation (at least 7 out of 10 sessions)? * How many parents complete the data collection 5 months after allocation on the primary exploratory clinical outcome, i.e., parental mentalizing skills? * Do parents who received the ATTACH(TM) program show more increase in their mentalizing skills, compared to parents, who did not receive treatment with ATTACH(TM)? Researchers will compare ATTACH, added to Treatment as Usual, with Treatment as Usual without ATTACH in three municipal family treatment centers located in the Capital Region of Denmark. Participants will: 1. Take part in baseline data collection with a survey, video observation of parent-child interaction, and an interview assessing mentalizing skills. 2. Be randomly allocated to receive treatment in their local family center with or without ATTACH. 3. Take part in data collection 5 months after being allocated to either group, as well as participate in an interview about their experiences with the treatment they received. 4. After one year, the research group will follow up on the current treatment/support needs of the families, who were allocated to either group.

Parenting for Lifelong Health Program in Kuwait

Parenting interventions play a crucial role in promoting positive parent-child interactions, which are fundamental to fostering child well-being. Over the years, substantial progress has been made in understanding the importance of these interactions, particularly in the context of early childhood development. Positive parent-child interactions lay the groundwork for various aspects of child development, including socioemotional skills, academic performance, and mental health. Evidence-based parenting programs have demonstrated strong effectiveness in promoting positive parenting and preventing child maltreatment. The Parenting for Lifelong Health (PLH) program has yielded positive outcomes in many countries. This project aims to culturally adapt the PLH program and conduct a randomized controlled trial (RCT) to assess its feasibility and effectiveness in Kuwait.

FAmily Oriented Mindfulness Informed Legal Education (FAMiLE) Programme for Parent or Carers Affected by Incarceration and Improving Parenting in Nigeria

Incarceration is a prevalent problem globally and in Nigeria. Its effect significantly impacts left behind parent or primary care givers and also the wellbeing of the families and children. Limited access to support has posed a constraint in effectively addressing the issues suffered by affected families in Nigeria. In addition, having a family member incarcerated could affect parenting due to factors such as anxiety, trauma, depression, poor social support, awareness of legal channels for complaint and harsh parenting to children. The implication is that it could not only have a negative impact on the affected victim but also on their parenting styles or caring responsibilities, which could be detrimental to children\'s development and wellbeing and resort to criminal behaviours. In essence this study seeks to examine the feasibility and acceptability of a brief FAmily oriented Mindfulness informed Legal Education (FAMiLE) intervention in comparison to the waitlist control group (who will be administered the intervention at a later date) in improving parenting, legal awareness, social cohesion, wellbeing and reducing trauma and anxiety as a result of the effect of having a family member incarcerated.

Problem Management Plus Mindfulness-informed Legal Education for Addressing Gender-based Violence and Improving Parenting

Gender-based violence and, more specifically, domestic violence is a prevalent problem globally and in Nigeria. Its effect significantly impacts women and also the wellbeing of their families. Limited access to support has posed a constraint in effectively addressing the issues suffered by affected victims in Nigeria. In addition, gender-based violence could affect parenting due to factors such as anxiety, trauma, depression, poor social support, limited awareness of legal channels for complaint and harsh parenting to children. The implication is that it could not only have a negative impact on the affected victim but also on their parenting styles or caring responsibilities, which could be detrimental to the child development, wellbeing and the potential subsequent resort to criminal behaviours. In essence, the current study aims to test the feasibility and acceptability of a novel cross disciplinary intervention titled, Problem Management plus Mindfulness-informed Legal Education (PM+MiLE) for addressing gender-based violence and improving parenting in Nigeria in comparison to the waitlist control group for the purposes of improving social cohesion, legal awareness, wellbeing and reducing depression, including trauma and anxiety as a result of experiencing gender-based violence, in Nigeria.