An Integrated Care Pathway for depression in adolescents: protocol for a Type 1 Hybrid Effectiveness-implementation, Non-randomized, Cluster Controlled Trial.

INTRODUCTION: Our group developed an Integrated Care Pathway to facilitate the delivery of evidence-based care for adolescents experiencing depression called CARIBOU-2 (Care for Adolescents who Receive Information 'Bout OUtcomes, 2nd iteration). The core pathway components are assessment, psychoeducation, psychotherapy options, medication options, caregiver support, measurement-based care team reviews and graduation. We aim to test the clinical and implementation effectiveness of the CARIBOU-2 pathway relative to treatment-as-usual (TAU) in community mental health settings. METHODS AND ANALYSIS: We will use a Type 1 Hybrid Effectiveness-Implementation, Non-randomized Cluster Controlled Trial Design. Primary participants will be adolescents (planned n = 300, aged 13-18 years) with depressive symptoms, presenting to one of six community mental health agencies. All sites will begin in the TAU condition and transition to the CARIBOU-2 intervention after enrolling 25 adolescents. The primary clinical outcome is the rate of change of depressive symptoms from baseline to the 24-week endpoint using the Childhood Depression Rating Scale-Revised (CDRS-R). Generalized mixed effects modelling will be conducted to compare this outcome between intervention types. Our primary hypothesis is that there will be a greater rate of reduction in depressive symptoms in the group receiving the CARIBOU-2 intervention relative to TAU over 24 weeks as per the CDRS-R. Implementation outcomes will also be examined, including clinician fidelity to the pathway and its components, and cost-effectiveness. ETHICS AND DISSEMINATION: Research ethics board approvals have been obtained. Should our results support our hypotheses, systematic implementation of the CARIBOU-2 intervention in other community mental health agencies would be indicated.

Suicidality risk in children and adolescents with externalizing disorders: symptoms profiles at high risk and the moderating role of dysregulated family relationships.

Children and adolescents with externalizing disorders are at risk for suicidal ideation or behavior. Factors that put them at risk could be symptoms related or facilitated by their environment. We evaluated the links of symptoms profiles with suicidality, and the effects of family relationship characteristics on these links. Latent profile analysis was used to subgroup participants referred for ADHD assessment (n = 1249, aged 6-17) based on their externalizing and internalizing symptoms. Self- and parent-reported child suicidal ideation (S-SI, P-SI), and parent-reported self-harm behavior (P-SHB) were compared across profiles. The moderating effects of parent-reported marital conflict and parenting practices were examined. A four-profile model showed optimal fit. Participants of the Low Symptoms profile followed by the Inattentive-Hyperactive/Impulsive profile showed lower P-SI compared to those of the Irritable-Defiant and the Conduct Problems profiles. Low Symptoms participants also reported lower S-SI compared to those of the Inattentive-Hyperactive/Impulsive and the Irritable-Defiant profiles. Participants of the Irritable-Defiant and the Conduct Problems profiles had higher P-SHB compared to the Low Symptoms and the Inattentive-Hyperactive/Impulsive participants. Dysregulated marital conflict practices were associated with greater increase in P-SI in all profiles compared to the Low Symptoms profile. Aggressive marital conflict practices were associated with increased P-SHB in the Conduct Problems profile compared to the Inattentive-Hyperactive/Impulsive profile. Children and adolescents with irritability and defiance symptoms with or without conduct problems show higher risk for suicidal ideation and behavior compared to those with ADHD symptoms alone. Dysregulated and aggressive marital conflict practices might pose additional suicidality risk in children and adolescents with disruptive behavior.

Stepping up to COVID-19: A Clinical Trial of a Telepsychology Positive Parenting Program Targeting Behavior Problems in Children With Neurological Risk.

OBJECTIVE: To evaluate the feasibility, acceptability, and preliminary efficacy of a stepped-care parenting program implemented during COVID-19 among families of behaviorally at-risk children with neurological or neurodevelopmental disorders aged 3-9 years. METHODS: Stepped-care I-InTERACT-North increased psychological support across 3 steps, matched to family needs: (1) guided self-help (podcast), (2) brief support, and (3) longer-term parent support. The intervention was provided by clinicians at The Hospital for Sick Children. Recruitment occurred via hospital and research cohort referral. A single-arm trial using a pragmatic prospective pre-post mixed-method design was utilized to assess accrual, engagement, acceptability, and preliminary efficacy. RESULTS: Over 15 months, 68 families enrolled (83% consent rate) and 56 families completed stepped-care (Step 1 = 56; Step 2 = 39; Step 3 = 28), with high adherence across Steps (100%, 98%, and 93%, respectively). Parents reported high acceptability, reflected in themes surrounding accessibility, comprehension, effectiveness, and targeted care. Positive parenting skill increases were documented, and robust improvement in child behavior problems was apparent upon Step 3 completion (p =.001, d = .390). Stepped-care was as effective as traditional delivery, while improving consent and completion rates within a pandemic context. CONCLUSIONS: This stepped-care telepsychology parenting program provides a compelling intervention model to address significant gaps in accessible mental health intervention while simultaneously balancing the need for efficient service. Findings inform program scalability beyond COVID-19 and emphasize the value of stepped-care intervention in delivering and monitoring mental health treatment.

Individual- and family-level associations between child psychopathology and parenting.

Parenting can protect against the development of, or increase risk for, child psychopathology; however, it is unclear if parenting is related to psychopathology symptoms in a specific domain, or to broad liability for psychopathology. Parenting differs between and within families, and both overall family-level parenting and the child-specific parenting a child receives may be important in estimating transdiagnostic associations with psychopathology. Data come from a cross-sectional epidemiological sample (N = 10,605 children ages 4-17, 6434 households). Parents rated child internalizing and externalizing symptoms and their parenting toward each child. General and specific (internalizing, externalizing) psychopathology factors, derived with bifactor modeling, were regressed on parenting using multilevel modeling. Less warmth and more aversive/inconsistent parenting in the family, and toward an individual child relative to family average, were associated with higher general psychopathology and specific externalizing problems. Unexpectedly, more warmth in the family, and toward an individual child relative to family average, was associated with higher specific internalizing problems in 4-11 (not 12-17) year-olds. Less warmth and more aversive/inconsistent parenting are broad correlates of child psychopathology. Aversive/inconsistent parenting, is also related to specific externalizing problems. Parents may behave more warmly when their younger children have specific internalizing problems, net of overall psychopathology.

Facial emotion recognition in children and youth with attention-deficit/hyperactivity disorder and irritability.

The ability to recognize emotions evident in people's faces contributes to social functioning and might be affected by ADHD and irritability. Given their high co-occurrence, we examined the relative contribution of ADHD and irritability to facial emotion recognition (FER). We hypothesized that irritability but not ADHD traits would predict increased likelihood of misrecognizing emotions as negative, and that FER performance would explain the association of ADHD and irritability traits with social skills. FER was measured using the Reading the Mind in the Eyes Test (RMET) in children (6-14 years old) referred for ADHD assessment (n = 304) and healthy controls (n = 128). ADHD, irritability and social skills were measured using parent ratings. We used repeated measure logistics regression, comparing the effects across emotion valence of images (i.e., neutral/positive/negative). High irritability but not ADHD diagnosis predicted lower RMET accuracy. ADHD traits predicted lower RMET accuracy in younger but not older participants, whereas irritability predicted poorer accuracy at all ages. ADHD traits predicted lower RMET accuracy across all emotion valences, whereas irritability predicted increased probability of misrecognizing neutral and positive but not negative emotions. Irritability did not increase the probability for erroneously recognizing emotions as negative. ADHD and irritability traits fully explained the association between RMET and social skills. ADHD and irritability traits might impact the ability to identify emotions portrayed in faces. However, irritability traits appear to selectively impair recognition of neutral and positive but not negative emotions. ADHD and irritability are important when examining the link between FER and social difficulties.

Developmental Precursors of Primary and Secondary Callous-Unemotional Traits in Youth.

There is growing evidence of diverse etiological pathways to the development of callous-unemotional (CU) traits, known as primary and secondary CU variants. The purpose of the present study was to extend previous cross-sectional research and examine theoretical predictors of CU variants prospectively from childhood to adolescence. Participants included high-risk control and normative samples from the Fast Track project (N = 754, male = 58%, Black = 46%). Using structural equation modelling, primary CU traits, identified in early adolescence, were associated with higher levels of childhood emotion regulation and lower levels of prosocial behavior. Secondary CU traits were associated with lower levels of childhood emotion regulation and low parental warmth, but not prosocial behaviour. Neither CU variant was related to harsh parenting. Parental warmth moderated emotion regulation and prosocial behavior on secondary CU traits. Results were not moderated by sex. A greater understanding of theoretical developmental precursors of CU variants may better guide intervention efforts.

Building I-INTERACT-North: Participatory Action Research Design of an Online Transdiagnostic Parent-Child Interaction Therapy Program to Optimize Congenital and Neurodevelopmental Risk.

To adapt an existing virtual family-based mental health intervention learning platform (I-InTERACT-North), using participatory action research design, to meet the needs of parents and children with congenital, neonatal, and neurodevelopmental conditions that impact development. A purposive sample of parent knowledge users recruited from a large pediatric hospital (n = 21) and clinician stakeholders (n = 16) participated in one interview. An iterative process was adopted to implement feedback in the adaption of the learning platform. Qualitative thematic analysis was used to examine themes across participant feedback. Initial satisfaction with the adapted website was high. Qualitative results revealed four themes: acceptability, usability, recommendations, and dissatisfaction. Addressed with iterations, technical difficulties, wanting more information on content, resources, and intended audience were areas of dissatisfaction. This study reflects the importance of participatory action research methods in informing virtual mental health interventions. Future directions to improve the learning platform are discussed.

Implementation and evaluation of a curriculum on the assessment and treatment of disruptive behaviour disorders.

Disruptive behaviour disorders (DBDs)-which can include or be comorbid with disorders such as attention-deficit hyperactivity disorder, oppositional defiant disorder, conduct disorder and disruptive mood dysregulation disorder-are commonly seen in paediatric practice. Given increases in the prescribing of atypical antipsychotics for children and youth, it is imperative that paediatric trainees in Canada receive adequate education on the optimal treatment of DBDs. We describe the development, dissemination, and evaluation of a novel paediatric resident curriculum for the assessment and treatment of DBDs in children and adolescents. Pre-post-evaluation of the curriculum showed improved knowledge in participants.

Comparing the Multicomponent Coping Power Program to Individualized Parent-Child Treatment for Improving the Parenting Efficacy and Satisfaction of Parents of Children with Conduct Problems.

This study compared the multicomponent Coping Power (group) program to individualized parent-child treatment with respect to changing the parenting efficacy and satisfaction of parents of children with conduct problems. One hundred fourteen parents of 9-12-year-old children with conduct problems were randomized to Coping Power or individualized treatment at an urban children's mental health clinic. Parents reported their pre- and post-treatment parenting efficacy and parenting satisfaction (Parent Sense of Competence Scale). Mixed effect models revealed that parenting efficacy and satisfaction significantly increased from pre- to post-treatment, and there was no evidence that this effect is different between Coping Power and individualized treatment, even after controlling for initial severity of child symptomatology. Findings support the effectiveness of Coping Power as an intervention for parenting efficacy and satisfaction among parents of children aged 9-12 years with conduct problems.

Effect of Comorbid Psychopathology and Conduct Problem Severity on Response to a Multi-component Intervention for Childhood Disruptive Behavior.

This study examined the effects of comorbid ADHD symptoms, internalizing psychopathology, Callous-Unemotional (CU) Traits, and conduct problem severity on children's response to an evidence-based psychosocial intervention. Clinic-referred children with DBD ages 8-12 years (N = 76) participated in a 15-week multi-component intervention. Parents provided weekly ratings of children's oppositionality-defiance, peer problems, and impairment. Oppositionality-defiance, peer problems, and impairment decreased significantly over the course of the intervention; however, there was considerable variability in weekly ratings. Baseline ADHD symptoms, internalizing psychopathology, CU traits, and conduct problem severity were unrelated to rate of change across treatment. However, ADHD symptoms uniquely predicted more oppositionality-defiance, peer problems, and impairment averaged across the 15 weeks of treatment. Follow-up analyses suggested this was driven by hyperactivity-impulsivity rather than inattention. Children with DBD and comorbid symptoms appear to benefit from a multi-component intervention, but those with ADHD symptoms may require additional support to address social and behavioral challenges.

Clinical Profiles of Children with Disruptive Behaviors Based on the Severity of Their Conduct Problems, Callous-Unemotional Traits and Emotional Difficulties.

This study identified clinical profiles of referred children based on the severity of callous-unemotional (CU) traits, emotional difficulties, and conduct problems. Parents of 166 children (132 males) aged 6-12 years referred to a hospital clinic because of disruptive behavior completed measures to assess these key indicators, and person-centered analysis was used to identify profiles. Four distinct profiles were identified that include: (1) Children low in severity on the three domains, (2) Children high in severity on the three domains, (3) Children high in severity in conduct problems and CU traits with minimal emotional difficulties, and (4) Children high in severity in conduct problems and emotional difficulties with minimal CU traits. Profiles differed in degree of aggression and behavioral impairment. Findings show that clinic-referred children with disruptive behaviors can be grouped based on these important indicators into profiles that have important implications for assessment and treatment selection.

Sustained impact of inattention and hyperactivity-impulsivity on peer problems: mediating roles of prosocial skills and conduct problems in a community sample of children.

This prospective 2-year longitudinal study tested whether inattentive and hyperactive/impulsive symptom dimensions predicted future peer problems, when accounting for concurrent conduct problems and prosocial skills. A community sample of 492 children (49 % female) who ranged in age from 6 to 10 years (M = 8.6, SD = .93) was recruited. Teacher reports of children's inattention, and hyperactivity/impulsivity symptoms, conduct problems, prosocial skills and peer problems were collected in two consecutive school years. Elevated inattention and hyperactivity/impulsivity in Year-1 predicted greater peer problems in Year-2. Conduct problems in the first and second years of the study were associated with more peer problems, and explained a portion of the relationship between inattention and hyperactivity/impulsivity with peer problems. However, prosocial skills were associated with fewer peer problems in children with elevated inattention and hyperactivity/impulsivity. Inattention and hyperactivity/impulsivity have negative effects on children's peer functioning after 1-year, but concurrent conduct problems and prosocial skills have important and opposing impacts on these associations.

Systematic Integration of Multi-Informant Externalizing Ratings in Clinical Settings.

Best practice clinical assessment of externalizing problems often necessitates collection of information from parents, youth themselves, and teachers. The present study tested the predictive validity of a psychometrically-driven scoring procedure to integrate multi-informant, dimensional ratings of externalizing problems. Participants were 2264 clinic-referred youth ages 6-18. Parents, teachers, and youth completed questionnaire ratings of externalizing problems (hyperactivity-inattention, conduct problems, and oppositionality-defiance) prior to an initial clinical appointment. The predictive validity of simple (highest informant rating; and all informant ratings separately) and more complex (latent S-1 bifactor model with specific informant factors; and moderated nonlinear factor analysis accounting for child age and sex) methods of informant integration was tested in predicting impairment, comorbidity, and number of clinical encounters. A simple model, in which all informant ratings were included, showed the best predictive validity across outcomes, performing as well or better than the use of the highest informant ratings or more complex latent variable models. The addition of child age and sex as moderators in the factor model did not improve predictive validity. Each informant (parent, teacher, and youth) contributes important information to the prediction of clinically-relevant outcomes. There is insufficient evidence at present to suggest that complex latent variable models should be favored over simpler models that preserve each informant's ratings.

Physiological Dysregulation in Children With and Without Externalizing Difficulties: Novel Insights From Intensive Longitudinal Data.

Extant research on physiological dysregulation in children has focused on point-in-time measures and absolute mean levels of physiology. However, these methods do not capture dynamic fluctuations in physiology that characterize dysregulation. In the present work, we aimed to assess whether physiological dysregulation as captured by fluctuations rather than mean levels would differentiate between children with and without clinically elevated levels of externalizing behavior. As an exploratory approach, we examined fluctuations in children's physiological responses (i.e., root mean square of successive differences [RMSSD] in beat-to-beat heart rate intervals) to social transgression scenarios across 15 short-term measurement occasions (5-second bins). Controlling for mean RMSSD, as well as emotional and cognitive correlates of externalizing behavior (i.e., sympathy and inhibitory control), children with externalizing difficulties exhibited greater within-person fluctuations in RMSSD (i.e., physiological dysregulation) compared to children without externalizing difficulties. The present findings provide preliminary support for using intensive longitudinal data comprised of short-term physiological measurements and point to the centrality of within-child physiological variability as a marker of dysregulation, particularly amongst children with externalizing disorders for whom self-regulation is a core challenge.

Predictors of Health-Related Quality of Life in Neurodivergent Children: A Systematic Review.

Health-related Quality of Life (HRQoL) is a multi-faceted construct influenced by a myriad of environmental, demographic, and individual characteristics. Our understanding of these influencers remains highly limited in neurodevelopmental conditions. Existing research in this area is sparse, highly siloed by diagnosis labels, and focused on symptoms. This review synthesized the evidence in this area using a multi-dimensional model of HRQoL and trans-diagnostically across neurodevelopmental conditions. The systematic review, conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Checklist, was completed in June 2023 using Medline, PsycInfo, Embase, PubMed, and Cochrane Library. Our search revealed 78 studies that examined predictors of HRQoL in neurodevelopmental conditions. The majority of these studies focused on autism and ADHD with a paucity of literature in other conditions. Cross-diagnosis investigations were limited despite the fact that many of the examined predictors transcend diagnostic boundaries. Significant gaps were revealed in domains of biology/physiology, functioning, health perceptions, and environmental factors. Very preliminary evidence suggested potentially shared predictors of HRQoL across conditions including positive associations between HRQoL and adaptive functioning, male sex/gender, positive self-perception, physical activity, resources, and positive family context, and negative associations with diagnostic features and mental health symptoms. Studies of transdiagnostic predictors across neurodevelopmental conditions are critically needed to enable care models that address shared needs of neurodivergent individuals beyond diagnostic boundaries. Further understanding of HRQoL from the perspective of neurodivergent communities is a critical area of future work.

Predictors of health-related quality of life for children with neurodevelopmental conditions.

Neurodevelopmental conditions can be associated with decreased health-related quality of life; however, the predictors of these outcomes remain largely unknown. We characterized the predictors of health-related quality of life (HRQoL) in a sample of neurodiverse children and youth. We used a cross-sectional subsample from the Province of Ontario Neurodevelopmental Disorders Network (POND) consisting of those children and young people in the POND dataset with complete study data (total n = 615; 31% female; age: 11.28 years ± 2.84 years). Using a structural equation model, we investigated the effects of demographics (age, sex, socioeconomic status), core features (Social Communication Questionnaire, Toronto Obsessive Compulsive Scale, Strengths and Weaknesses of attention deficit/hyperactivity disorder (ADHD)-symptoms and Normal Behavior), co-occurring symptoms (Child Behaviour Checklist), and adaptive functioning (Adaptive Behaviour Assessment System) on HRQoL (KINDL). A total of 615 participants had complete data for this study (autism = 135, ADHD = 273, subthreshold ADHD = 7, obsessive-compulsive disorder (OCD) = 38, sub-threshold OCD = 1, neurotypical = 161). Of these participants, 190 (31%) identified as female, and 425 (69%) identified as male. The mean age was 11.28 years ± 2.84 years. Health-related quality of life was negatively associated with co-occurring symptoms (B = - 0.6, SE = 0.20, CI (- 0.95, - 0.19), p = 0.004)) and age (B = - 0.1, SE = 0.04, CI (- 0.19, - 0.01), p = 0.037). Fewer co-occurring symptoms were associated with higher socioeconomic status (B = - 0.5, SE = - 0.05, CI (- 0.58, - 0.37), p < 0.001). This study used a cross-sectional design. Given that one's experiences, needs, supports, and environment and thus HrQoL may change significantly over the lifespan and a longitudinal analysis of predictors is needed to capture these changes. Future studies with more diverse participant groups are needed. These results demonstrate the importance of behavioural and sociodemographic characteristics on health-related quality of life across neurodevelopmental conditions.

The Toronto Adolescent and Youth Cohort Study: Study Design and Early Data Related to Psychosis Spectrum Symptoms, Functioning, and Suicidality.

BACKGROUND: Psychosis spectrum symptoms (PSSs) occur in a sizable percentage of youth and are associated with poorer cognitive performance, poorer functioning, and suicidality (i.e., suicidal thoughts and behaviors). PSSs may occur more frequently in youths already experiencing another mental illness, but the antecedents are not well known. The Toronto Adolescent and Youth (TAY) Cohort Study aims to characterize developmental trajectories in youths with mental illness and understand associations with PSSs, functioning, and suicidality. METHODS: The TAY Cohort Study is a longitudinal cohort study that aims to assess 1500 youths (age 11-24 years) presenting to tertiary care. In this article, we describe the extensive diagnostic and clinical characterization of psychopathology, substance use, functioning, suicidality, and health service utilization in these youths, with follow-up every 6 months over 5 years, including early baseline data. RESULTS: A total of 417 participants were enrolled between May 4, 2021, and February 2, 2023. Participants met diagnostic criteria for an average of 3.5 psychiatric diagnoses, most frequently anxiety and depressive disorders. Forty-nine percent of participants met a pre-established threshold for PSSs and exhibited higher rates of functional impairment, internalizing and externalizing symptoms, and suicidality than participants without PSSs. CONCLUSIONS: Initial findings from the TAY Cohort Study demonstrate the feasibility of extensive clinical phenotyping in youths who are seeking help for mental health problems. PSS prevalence is much higher than in community-based studies. Our early data support the critical need to better understand longitudinal trajectories of clinical youth cohorts in relation to psychosis risk, functioning, and suicidality.

Cognition and Educational Achievement in the Toronto Adolescent and Youth Cohort Study: Rationale, Methods, and Early Data.

BACKGROUND: Both cognition and educational achievement in youths are linked to psychosis risk. One major aim of the Toronto Adolescent and Youth (TAY) Cohort Study is to characterize how cognitive and educational achievement trajectories inform the course of psychosis spectrum symptoms (PSSs), functioning, and suicidality. Here, we describe the protocol for the cognitive and educational data and early baseline data. METHODS: The cognitive assessment design is consistent with youth population cohort studies, including the NIH Toolbox, Rey Auditory Verbal Learning Test, Wechsler Matrix Reasoning Task, and Little Man Task. Participants complete an educational achievement questionnaire, and report cards are requested. Completion rates, descriptive data, and differences across PSS status are reported for the first participants (N = 417) ages 11 to 24 years, who were recruited between May 4, 2021, and February 2, 2023. RESULTS: Nearly 84% of the sample completed cognitive testing, and 88.2% completed the educational questionnaire, whereas report cards were collected for only 40.3%. Modifications to workflows were implemented to improve data collection. Participants who met criteria for PSSs demonstrated lower performance than those who did not on numerous key cognitive indices (p < .05) and also had more academic/educational problems. CONCLUSIONS: Following youths longitudinally enabled trajectory mapping and prediction based on cognitive and educational performance in relation to PSSs in treatment-seeking youths. Youths with PSSs had lower cognitive performance and worse educational outcomes than youths without PSSs. Results show the feasibility of collecting data on cognitive and educational outcomes in a cohort of youths seeking treatment related to mental illness and substance use.

Autonomic Arousal, Ethical Guilt, and Externalizing Behavior in Childhood: A Clinical Extension and Replication.

Lower autonomic arousal is associated with higher externalizing behavior in childhood but the mechanisms explaining this link are still debated. One possibility is that lower autonomic arousal makes it difficult for children to anticipate or express social emotions, such as ethical guilt rooted in concern for others, thereby increasing their likelihood of externalizing behavior. However, evidence for this social-emotional hypothesis has been limited to community samples. The present study included ethnically diverse samples of 150 typically developing children (Mage = 8.01 years; 50% girls) and 62 children referred for clinically elevated externalizing behavior (Mage = 9.16 years; 16% girls; N = 212). Caregivers reported children's externalizing behavior. Children's respiratory sinus arrhythmia (RSA) was measured as an indicator of parasympathetic activity in response to hypothetical vignettes depicting externalizing behavior. Children's ethical guilt was coded from semi-structured interviews following each vignette. Greater RSA increases (indicating a low-arousal, rest-and-digest response) were associated with lower ethical guilt. Lower ethical guilt was associated with higher externalizing behavior. A significant indirect effect showed that RSA increases were associated with higher externalizing behavior through relative lapses in ethical guilt. Results were consistent across and within the community and clinical samples. Theoretical and practical implications for clinically elevated externalizing behavior are discussed.

Protocol for a randomized control trial of the Building Regulation in Dual Generations Program (BRIDGE): preventing the intergenerational transmission of mental illness in at-risk preschool children.

BACKGROUND: Since the onset of the COVID-19 pandemic, the worldwide prevalence of maternal depression has risen sharply; it is now estimated that one quarter of mothers experience clinically significant depression symptoms. Exposure to maternal depression during early childhood increases the risk for the development of childhood mental illness (MI) in offspring, with altered parenting practices mediating the association between maternal depression and child outcomes. Dual-generation interventions, which aim to simultaneously treat parent and child mental health, show promise for improving outcomes for mothers with depression and their young children. The Building Regulation in Dual Generations (BRIDGE) program combines Dialectical Behavior Therapy (DBT) and parenting skills training to concurrently treat maternal depression and improve parenting practices. In pilot within-group studies, BRIDGE has led to large reductions in maternal depression and child MI symptoms. The aim of the current study is to evaluate the efficacy of BRIDGE in reducing maternal depression and child MI symptoms (primary outcomes) as well as parenting stress and harsh parenting (secondary outcomes). METHODS: A three-armed randomized control trial with equal group sizes will be conducted to compare the efficacy of (1) BRIDGE (DBT + parenting skills), (2) DBT skills training, and (3) services-as-usual. Participants (n = 180) will be mothers of 3- to 5-year-old children who report elevated depression symptoms. Those randomized to BRIDGE or DBT skills training will complete a 16-week group therapy intervention. Assessments will be administered at pre-intervention(T1) post-intervention (T2), and 6-month follow-up (T3). DISCUSSION: Dual-generation programs offer an innovative approach to prevent the intergenerational transmission of mental illness. The current study will add to the evidence base for BRIDGE by comparing it to a stand-alone mental health intervention and a services-as-usual group. These comparisons will provide valuable information on the relative efficacy of including parenting support in a mental health intervention for parents. The results will contribute to our understanding of how maternal depression affects children's development and how intervening at both a mental health and parenting level may affect child and family outcomes. TRIAL REGISTRATION: Name of registry: Clinical Trials Protocol Registration and Results System; trial registration number: NCT05959538; date of registry: July 24, 2023; available: https://classic. CLINICALTRIALS: gov/ct2/show/NCT05959538.