Abstract
Reduced activation of the Research Domain Criteria (RDoC) positive valence systems (PVS) is observed in high-risk (HR) children of depressed mothers and predictive of future psychopathologies. We developed a dyadic, neuroscience-informed preventive intervention, Family Promoting Positive Emotions (FPPE), designed to prevent psychopathology in HR children by targeting PVS processes. The current study evaluated the initial efficacy of FPPE compared to written information (WI) psychoeducation in engaging PVS-related targets and reducing perceived stress and emotional distress symptoms in HR youth. Participants included 74 children ages 8-12 years and their biological mothers reporting elevated depressive symptoms. Following random assignment, 55 dyads completed FPPE (n=29) or WI (n=26) and pre-post assessments of child clinical symptoms. Youth completed a reinforcement learning task and 10 days of positive affect ratings to assess PVS-related targets. Results revealed a small within-subjects increase in child daily positive affect in FPPE, but not WI. Further, FPPE, versus WI, resulted in reductions in mother-reported child perceived stress and symptoms of anger, anxiety, and depression with medium-to-large within-subjects effects. Intervention effects on reinforcement learning and child-rated clinical symptoms were not observed. This study suggests FPPE shows promise in enhancing PVS function and reducing the emergence of clinical symptoms in HR children.
ClinicalTrials.gov Identifier:
Keywords: depression, early intervention, positive emotions, cognitive behavior therapy, parent child relations, stress
Offspring of mothers with depression are at elevated risk for many forms of psychopathology across the lifespan. By adolescence, 40% of offspring of mothers with major depressive disorder (MDD) develop depression compared to 10-15% of youth in the general population (Murray et al., 2011; Weissman et al., 2016). Youth of depressed mothers are also at heightened risk for anxiety disorders and externalizing psychopathologies (Goodman et al., 2011; Hammen, 2009). Further, a study following offspring over 30 years demonstrated an increased mortality rate in offspring of depressed parents with an approximate 8-year difference in the mean age at death compared to offspring of parents with no history of depression (Weissman et al., 2016). Given these alarming statistics, there is a critical need for preventive interventions that directly target risk processes in high-risk (HR) youth of depressed mothers to alter emotional and behavioral risk trajectories across development.
Reduced activation of the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) positive valence systems (PVS) is consistently observed in children of depressed mothers prior to the onset of psychiatric disorders (for reviews, see Burkhouse & Kujawa, 2023; Kujawa & Burkhouse, 2017) and may be a viable prevention target for HR youth. Specifically, studies probing PVS processes at the brain and behavioral levels indicate that HR youth exhibited blunted ventral striatum activation, reduced electroencephalogram (EEG) responses to reward, and impairments in reward learning (Burkhouse & Kujawa, 2023; Kujawa & Burkhouse, 2017). Further, there is compelling evidence that attenuated reward responses prospectively predict depressive symptom increases into early adolescence (Kujawa et al., 2019; Kujawa & Burkhouse, 2017) and responses to stress (Goldstein et al., 2020). As such, prevention programs that directly target PVS function may hold promise for preventing depression and other forms of psychopathology characterized by low PVS function.
NIMH has argued for an experimental therapeutics approach directly targeting core mechanisms of psychopathology (Insel & Gogtay, 2014). Yet, few studies have translated findings from affective neuroscience mechanistic research to personalized approaches to prevention in HR offspring. Prior prevention programs developed for HR youth incorporate cognitive, behavioral, and/or interpersonal therapy techniques, usually targeting heterogenous depressive symptoms in offspring (for reviews, see Gladstone & Beardslee, 2009; Loechner et al., 2018; Rishel, 2012), with small-to-medium effect sizes (Hetrick et al., 2015; Loechner et al., 2018; Rishel, 2012). Given the consistent evidence that reduced PVS activation plays a key role in depression and other psychopathologies, prevention programs that focus directly on enhancing PVS function in HR youth may increase resilience and yield stronger response rates for the prevention of psychopathology. Indeed, adult intervention studies provide promising support for the notion that treatments designed to manipulate PVS processes are effective in alleviating symptoms of depression (for a review, see Nielson et al., 2021). For instance, deep brain stimulation of reward-related brain regions has been shown to be effective in reducing internalizing symptoms across several studies (for a review, see Nielson et al., 2021), and this may result from increasing neural reward responsiveness pre-to-post brain stimulation (Figee et al., 2013). Other research with pharmacological and psychotherapeutic interventions indicates that gold-standard treatments for depression may work by enhancing PVS processes across behavioral and brain units of analysis (Burkhouse et al., 2018; Nielson et al., 2021; Craske et al., 2023); however, this work has yet to be translated to prevention efforts for youth at high risk for depression.
This preliminary study took an innovative experimental therapeutics approach to the prevention of emotional disorders in youth of depressed mothers. To directly target PVS, we developed Family Promoting Positive Emotions (FPPE), a dyadic, neuroscience-informed preventive intervention. FPPE was inspired in part by Positive Affect Treatment (PAT), a 15-session individual intervention for adults with depression or anxiety (Craske et al., 2016, 2019, 2023). PAT teaches skills to enhance positive affect, including positive emotion psychoeducation, pleasant events scheduling, attending to and savoring the positive, and cultivating the positive through gratitude and loving kindness. In two randomized controlled trials (RCT), PAT has been shown to lead to greater improvements in positive affect, depression, anxiety, and suicidal ideation across time, compared to a negative affect intervention (Craske et al., 2019, 2023). In addition, improvements in PVS processes, such as reward anticipation and responsiveness, correlated with improvements in clinical measures pre-to-post PAT (Craske et al., 2023), supporting the clinical utility of targeting PVS through intervention. This work is complemented by RCTs with adults showing that interventions aimed at enhancing PVS processes (e.g., positive cognitive-behavioral therapies, augmented depression therapy, amplification of positivity) are effective in decreasing depression and anhedonia (Chaves et al., 2017; Dunn et al., 2019; Geschwind et al., 2019; Taylor et al., 2020), but this research has yet to be extended to preventive interventions for children.
Given the role of social dynamics in positive emotions (Brown & Fredrickson, 2021), FPPE uses a dyadic approach to engage mother–child pairs in a skills-based intervention, with developmentally appropriate content to enhance pleasant activities as well as attention to, anticipation, savoring, and cultivation of the positive in mothers and children. Through skills training, practice, and individual and dyadic goals, FPPE is designed to directly target PVS function, with the potential to prevent the emergence of depression and other emotional problems in HR youth. Like cognitive behavioral approaches to depression prevention and treatment (Compas et al., 2009; Lewinsohn et al., 1990), FPPE includes a focus on pleasant events scheduling to increase rewards in the environment, but specifically in the context of the mother–child relationship and complements these behavioral skills with unique cognitive approaches to upregulate positive emotions. FPPE is administered in weekly dyadic sessions with a skills coach, mother, and child and provides and involves personalized feedback, encouraging dyads to capitalize on each other’s positive emotions, increase enjoyable activities, and cultivate positivity within the family context.
FPPE was designed for children in late childhood to early adolescence, a developmental period before the emergence of an adolescent-specific developmental changes in PVS functions, such as reward responsiveness (Kujawa, Klein, et al., 2020) and heightened risk for internalizing symptoms (Bennik et al., 2014; Lee & Gotlib, 1991; Luoma et al., 2001; Williamson et al., 2004). Moreover, the intervention was developed specifically for HR mother–child dyads, given evidence that offspring of depressed mothers are at heightened risk for psychopathology and exhibit alterations in PVS function at this stage of development. FPPE is administered virtually to support scalability, and skills are delivered in eight sessions to minimize burden on families and given evidence that shorter prevention programs generate larger effect sizes (Stice et al., 2009).
In this pilot RCT study, we used a multi-method approach to examine the initial efficacy of FPPE compared to a written information (WI) psychoeducation intervention. Although there is no established treatment-as-usual comparison for children before the emergence of clinically significant symptoms, psychoeducation is a common and effective approach for preventive interventions, including for depression (Beardslee et al., 1997, 2003), with evidence of small-to-medium effects on youth internalizing symptoms (Compas et al., 2011). We tested FPPE’s ability to engage key PVS-related targets and hypothesized that FPPE would increase daily positive affect in children and performance on a widely using reinforcement learning task (Luking et al., 2016; Pizzagalli et al., 2005) compared to WI. Next, we tested the effects of FPPE on child symptoms of emotional distress, including anger, anxiety, and depression. Given the study was conducted in the context of the COVID-19 pandemic and the role of PVS in shaping responses to stress, we also examined intervention effects on perceived stress. We hypothesized that FPPE would lead to reductions in clinical symptoms and perceived stress compared to WI.
Methods
Participants
Participants were 74 U.S. children (8-12 years old) and their biological mothers with elevated depressive symptoms. Recruitment began in November 2021 and concluded in October 2022. Families were recruited through social media, online advertisements, and flyers, and all assessments and intervention sessions were conducted virtually. To focus on prevention rather than treatment, mothers who reported current depressed mood or anhedonia in offspring (present for at least half of the time in the past 2 weeks based on the DSM-5 Level 1 Cross-Cutting Symptom Measure; Bastiaens & Galus, 2018) were excluded. Given evidence that overactivation of PVS may underlie some forms of psychopathology (Baskin-Sommers & Foti, 2015; Nusslock & Alloy, 2017), children or mothers with prior diagnoses of bipolar or mania were excluded, as were mothers reporting current substance use problems. Significant developmental or intellectual disabilities and psychotic disorders (based on mother report of prior diagnoses) were also exclusionary for mothers and children.
Of families assigned to FPPE, 18 withdrew prior to completing the intervention. The average number of sessions attended for families who withdrew after starting FPPE was 1.89 (SD=1.36). Fifty-five participants completed their assigned intervention (29 FPPE, 26 WI) and pre- and post-intervention measures (Figure 1) and were included in analyses of intervention completers. We also conducted intention-to-treat analyses including all 74 participants who completed pre-intervention measures and were randomized.1
Figure 1.
CONSORT diagram depicting the study design and sample sizes.
Among intervention completers, children were 43.6% girls, 54.5% boys, and 1.8% nonbinary, with a mean age of 9.65 years (SD=1.24). Children identified as 13.0% Hispanic or Latinx, 16.4% Black or African American, 1.8% Asian, 70.9% White, and 10.9% biracial. On average, mothers were 39.11 years (SD=5.36) and identified as 10.9% Hispanic or Latinx, 16.4% Black or African American, 76.4% White, and 7.3% multiracial or another race. Most mothers (74.5%) completed a college degree, and the median household income was $80,000-$89,999 (Range: <$10,000-$100,000+). Demographic characteristics of FPPE vs. WI dyads are presented in Table 1. The groups did not significantly differ on any measures. Families completing the assigned intervention did not significantly differ from those who withdrew early on most measures (ps>.24); however, mothers completing the intervention were older than those who did not, t(72)=1.97, p=.03, d=.60 (95% CI: −1.13 to −.07).
Table 1.
Demographic characteristics of families completing FPPE (n=29) vs. WI (n=26)
| FPPE (n=29) | WI (n=26) | Group difference | |
|---|---|---|---|
| M (SD) | Cohen’s d | ||
| Child age | 9.38 (1.24) | 9.96 (1.18) | 0.48 |
| Mother age | 38.48 (5.58) | 39.81 (5.13) | 0.25 |
| Mother depressive symptoms at screening | 12.14 (3.57) | 11.27 (3.01) | −0.26 |
| % | Chi-Square | ||
| Child gender (% girls) | 41.4% | 46.2% | 0.97 |
| Child race | 1.85 | ||
| White | 72.4% | 69.2% | |
| Black | 17.2% | 15.4% | |
| Biracial | 6.9% | 15.4% | |
| Child ethnicity (% Hispanic/Latinx) | 3.6% | 23.1% | 4.55 |
| Mother education (% college degree or higher) | 82.8% | 65.4% | 2.18 |
| Household income (% $70,000 and above) | 62.1% | 57.7% | 0.11 |
Note: *p ≤.05
Ethical Considerations
Study procedures were registered on clinicaltrials.gov (NCT05223842, https://clinicaltrials.gov/ct2/show/NCT05223842) and approved by the Vanderbilt Institutional Review Board. Written informed consent was obtained from mothers and assent from children prior to the start of study procedures.
Procedures
Interested mothers were directed to a REDCap screening form to determine initial eligibility. Following informed consent, mothers completed the Patient Health Questionnaire (Kroenke et al., 2001); scores ≥8, indicating mild current symptoms, were required for inclusion.2 Mothers were also asked whether they or their child had ever been diagnosed with bipolar disorder or mania, psychotic disorders or schizophrenia, intellectual disability, or developmental disabilities, and rated their own current substance use and child’s current depressive symptoms. Next, eligible families completed informed consent and child assent via videoconference with the study coordinator, followed by baseline measures of child symptoms and reinforcement learning. Children then completed 10 days of daily surveys of positive affect. Families were randomized to 8 sessions of FPPE, administered by a Masters- or PhD-level skills coach supervised by A.K. and K.B., or to a written information condition in which psychoeducation materials were provided weekly to families electronically for 8 weeks. A parallel trial design was used. Randomization was completed by generating random numbers in Excel. Each random number was ranked based on the total expected sample size, and the list was divided into two groups (initially 25/group). Participants were assigned to groups by the study coordinator according to the random numbers.3 Following completion of FPPE or WI, families completed post-intervention measures through a videoconference with the study coordinator.
FPPE
FPPE is a structured, manualized intervention developed to enhance positive emotions in HR children. Mothers completed an orientation session with the skills coach to address recommendations for intervention sessions (e.g., minimizing distractions, focusing on the positive, offering praise). Each FPPE session began with an icebreaker game to engage the dyad and to set the tone for the positive mood of the session, followed by homework review4 with positive reinforcement for progress towards goals, introduction of new content, dyadic practice, and reinforcement by the skills coach. Sessions ended with collaborative identification of individual and shared goals for the week and a specific plan for accomplishing goals. Both the parent and the child were provided engaging workbooks to summarize skills in developmentally appropriate ways and offer a place to record assignments and track goal progress.
Session 1 focused on positive emotion psychoeducation and recognizing connections between feelings, thoughts, and behaviors as well as how others’ emotions impact our own. Similar to CBT for depression (Lewinsohn et al., 1990), the intervention relied heavily on pleasant events but focused on mother–child activities. Beginning in Session 2 and continuing throughout the intervention, mothers and children identified individual and shared goals for pleasant activities and were encouraged to increase the frequency of these activities across time, with a specific focus on active, social, and success activities. Cognitive skills including attending to, savoring, anticipating, and taking credit for the positive were introduced in Sessions 3 through 5. Cognitive skills emphasized increasing attention to and the salience of positive aspects of mothers’ and children’s environments and relationships, rather than traditional cognitive restructuring in CBT, which focuses on changing negative thoughts. Cultivating gratitude and love in the family was introduced in Sessions 6 and 7 and included developing a shared gratitude practice and recognizing positives of the self and each other. Session 8 focused on skills review and future planning.
For fidelity and treatment adherence, video-recorded sessions were recorded and a subset of 20 sessions (8.03% of the total 249 sessions completed) were reviewed by clinical psychologists K.B. and A.K. who rated adherence to FPPE components expected in each session. On average, 96.25% (SD=7.14) of key FPPE components were included (5 sessions were double coded for inter-rater reliability with 100% agreement).
Written Information (WI)
For a comparison condition, mothers were provided written information materials addressing psychoeducation on depression in families, warning signs of depression in children and adolescents, helping children cope with stress, and how to find quality treatment services. Written information materials were shared through 8 engaging, weekly newsletter-style emails to mothers, with each covering a specific topic and including links to mental health resources and online videos for additional information. A trained research assistant sent text messages to mothers in the WI condition at weeks 1, 4, and 8 to ensure receipt of materials and answer any questions.
Measures
Intervention satisfaction
Mothers and children rated their satisfaction with the intervention, understanding of the skills, and how helpful the materials and skills were on a scale of 1 (not at all) to 5 (very much so) following each FPPE session or WI email. Children in FPPE completed a similar satisfaction survey, but children in WI did not, given that information was sent directly to mothers without an expectation for child involvement. The 3 items (i.e., satisfaction, understanding, helpful) were averaged across all session completed for each participant to derive total satisfaction ratings. Internal consistency of the 3 items at the initial session was acceptable (Cronbach’s αs=.69 for parent report and .86 for child).
Daily positive affect
To assess child positive affect pre- and post-intervention, children completed the brief version of the Positive and Negative Affect Schedule (Ebesutani et al., 2012), which was emailed to families 1 time per day on weekdays and 2 times per day on weekends for 10 days before and 10 days immediately following the intervention (maximum of 14 prompts total). This schedule was selected to allow for detection of real-world experiences of positive affect, while minimizing burden on participants from longer or denser sampling. Mothers’ email addresses were used, and they were instructed to have their child complete the questionnaire on their smartphone or computer as soon as possible. Children were instructed to rate how they were feeling in the moment on a scale of 1 (very slightly or not at all) to 5 (extremely) for 5 positive emotions. On average participants completed 11.05 (SD = 2.62; range: 2-14) surveys pre-intervention and 10.16 (SD = 2.89; range: 1-14) post-intervention. Analyses focused on average positive affect pre- and post-intervention, which demonstrated good internal consistency at both assessments (αs=.86-.93).
Emotional distress
Broader symptom outcomes were assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS), which include brief, widely available measures validated for youth 8 to 12 years old (Fries et al., 2005). Mothers and children completed the PROMIS Emotional Distress scales pre- and post-intervention, which consist of 5 to 15 items each rated on a 5-point scale and assess anger, anxiety, and depressive symptoms in the past 7 days (Irwin et al., 2010). All subscales demonstrated good internal consistency across both time points and self and informant reports (αs=.82-.92). Pre-intervention parent report was missing for one WI family.
Perceived stress
The NIH Toolbox Perceived Stress Scale (PSS) is a well-supported 10-item measure of subjective experiences of stress with both parent and child self-report versions that demonstrates strong psychometric properties (Cohen et al., 1983; Kupst et al., 2015) and was completed by mothers and children pre- and post-intervention. The PSS assesses feelings of stress in response to a range of life circumstances in the past month (e.g., “How often have you been angered because of things that happened that were outside of your control?”). The PSS demonstrated acceptable to good internal consistency pre- and post-intervention (child-reported αs=.64-.73; mother-reported αs=.81-.88).
Reinforcement learning task
During pre- and post-intervention assessments, children completed a well-established computerized reinforcement learning task (Pizzagalli et al., 2005), previously adapted for children as young as 7 (Luking et al., 2016). Participants were sent a hyperlink to the task on Cognition.run via videoconferencing chat with the study coordinator. Mothers read the instructions on the screen to the child and once the game began, mothers were instructed to let the child complete the task on their own. Children completed three blocks consisting of 50 trials each (150 trials total). In the task, a simple face stimulus is presented with either a short or long mouth, and participants are prompted to select whether the stimulus is short or long. Feedback indicating a correct response and a reward is presented, with 1 button more likely to elicit positive feedback than the other. The extent to which children preferentially select the button that is more likely to be reinforced across the task was used to quantify reinforcement learning. Response bias was calculated based on prior work (Pizzagalli et al., 2005) as:
A higher response bias indicates that participants showed increased accuracy for more frequently rewarded vs. less frequently rewarded stimuli. Reinforcement learning data were missing for 3 participants pre-intervention and 2 participants post-intervention.
Data Analysis
First, mixed-design ANOVAs were conducted in SPSS (version 27) to test the group (FPPE vs. WI) x time (pre- and post-intervention) effects on primary outcome measures (daily positive affect, child emotional distress, and perceived stress). Given the proof-of-concept approach and concerns with interpreting between-subject effects for pilot efficacy trials with relatively small samples (Kistin & Silverstein, 2015; Leon et al., 2011), we also used paired samples t-tests to examine pre- to post-intervention change in both the FPPE and WI groups with one-tailed p-values (Figures 2, 3,4,and 5), given a priori hypotheses, and examined effect sizes and 95% confidence intervals. We first conducted analyses in intervention completers only (29 in FPPE, 26 in WI). For intention-to-treat, mixed-design ANOVAs were repeated using restricted estimation maximum likelihood (REML) in the lme4 package in R (Bates et al., 2015) including all participants who completed intake measures and were randomized to an intervention (47 in FPPE, 27 in WI).
Figure 2.
Bar graph depicting child response bias on the reinforcement learning task pre- and post-intervention for youth completing FPPE vs. WI. Note: *p ≤.05, **p<.01, ***p<.001, Cohen’s d represents the within-subjects effect.
Figure 3.
Bar graphs depicting child-reported daily positive affect and emotional distress pre- and post-intervention for youth completing FPPE vs. WI. Note: *p ≤.05, **p<.01, ***p<.001, Cohen’s d represents the within-subjects effect.
Figure 4.
Bar graphs depicting parent-reported child emotional distress and perceived stress pre- and post-intervention for youth completing FPPE vs. WI. Note: *p ≤.05, **p<.01, ***p<.001, Cohen’s d represents the within-subjects effect.
Results
Participant Satisfaction with FPPE
Including all participants who completed any sessions, there was a trend such that mothers’ mean satisfaction ratings across sessions were higher in FPPE (M=4.71, SD=.28) compared to WI (M=4.50, SD=.48), t(38.57)=1.95, p=.06, d=.38 (95% CI: .03 to 1.04). Importantly, satisfaction ratings (scored out of 5) were relatively high in both conditions, supporting psychoeducation as a useful comparison condition. Children in FPPE also reported generally high satisfaction across sessions (M=3.97, SD=0.85), although ratings were somewhat lower than those observed for mothers.
In open-ended post-intervention items, both mothers and children generally reported liking the positive focus and dyadic structure of FPPE (mothers: e.g., “It focused on positive things, and always left me feeling more optimistic.”; “I liked working on this together with my son and seeing his progress in recognizing positivity. Finding the ways to use positive skills daily was helpful.”; children: e.g., “I liked that I got to spend time with mommy.”; “I loved it all and it was very easy to understand.”).
Pre-Intervention Group Differences
FPPE and WI completers did not differ on response biases, or child- or parent-reported emotional distress or perceived stress prior to the interventions (ds=.001 to .39, ps>.16), but children completing FPPE reported lower daily positive affect prior to the intervention compared to those in WI, t(53)=−2.08, p=.02, d=−.56 (95% CI: −1.10 to −.02).
Daily Positive Affect and Reinforcement Learning
Descriptive statistics of positive affect and responses biases pre- and post-intervention in each group are presented in Table 2 and depicted in Figures 2 and 3. The group × time interaction on daily child positive affect, F(1,53)=1.25, p=.27, ηp2=.02, was not significant. Within-subjects analyses indicated that positive affect increased from pre- to post-intervention in the FPPE group, t(28)=1.94, p=.03, d=.36 (95% CI: −.02 to .73), but not the WI group, t(25)=.06, p=.48, d=.01 (95% CI: −.37 to .40). Contrary to hypotheses for reinforcement learning, there was a trend effect of time, such that response bias scores decreased overall, F(1,48)=2.53, p=.12 ηp2=.05, but the group × time interaction was not significant, F(1,48)=.25, p=.62, ηp2=.005 and reinforcement learning did not significantly change across time for children in either group (ps>.09).
Table 2.
Pre- and post-intervention measures FPPE (n=29) vs. WI (n=26)
| FPPE Pre | FPPE Post | WI Pre | WI Post | |||
|---|---|---|---|---|---|---|
| M (SD) | d | M (SD) | d | |||
| Response bias | 1.25 (.50) | 1.09 (.31) | −.26 | 1.16 (.36) | 1.07 (.31) | −.19 |
| Child report | ||||||
| Positive affect | 23.99 (4.63) | 25.15 (4.61) | .36* | 26.43 (4.04) | 26.48 (4.54) | .01 |
| Anger | 13.83 (4.97) | 13.38 (5.20) | −.09 | 12.88 (4.26) | 12.04 (4.73) | −.20 |
| Anxiety | 26.03 (10.54) | 23.90 (8.92) | −.27 | 24.15 (8.04) | 23.08 (8.63) | −.22 |
| Depression | 25.03 (9.82) | 23.59 (8.58) | −.18 | 22.19 (7.19) | 23.38 (9.55) | .12 |
| Perceived stress | 26.93 (4.87) | 26.38 (5.95) | −.14 | 25.27 (6.09) | 24.88 (4.68) | −.06 |
| Parent report | ||||||
| Anger | 12.52 (4.09) | 10.48 (3.90) | −.52** | 12.52 (4.12) | 12.00 (3.94) | −.15 |
| Anxiety | 18.09 (7.62) | 14.83 (4.97) | −.58** | 18.53 (6.22) | 17.52 (5.59) | −.19 |
| Depression | 21.31 (7.32) | 17.31 (5.39) | −.64*** | 21.66 (7.00) | 20.48 (6.58) | −.20 |
| Perceived stress | 25.24 (7.09) | 20.62 (5.51) | −.61** | 25.32 (6.66) | 25.04 (4.45) | −.05 |
Note: *p ≤.05, **p<.01, ***p<.001; Cohen’s d represents the within-subjects effect.
Child Symptom Outcomes
Child Report
Descriptive statistics of child-reported symptom measures pre- and post-intervention in each group are presented in Table 2 and depicted in Figure 3. The group × time interactions for child-reported depression, anxiety, anger, and perceived stress did not reach significance (ps>.30). In addition, no significant within-subjects changes in child-reported symptoms were observed in either the WI (ps>.13) or FPPE (ps>.08) groups.
Parent Report
Descriptive statistics of parent-reported symptom measures pre- and post-intervention in each group are presented Table 2 and depicted in Figure 3. The group × time interaction for parent-reported child perceived stress, F(1,52)=5.79, p=.02, ηp2=.10, was significant, with a trend for similar effects on child symptoms of depression, F(1,52)=2.97, p=.09, ηp2=.05. The group × time interaction was not significant for anxiety, F(1,52)=2.20, p=.15, ηp2=.04 or anger, F(1,52)=2.21, p=.14, ηp2=.04. All parent-reported symptom dimensions significantly decreased from pre- to post-intervention in the FPPE group: t(28)=−3.47, p<.001, d=−.64 (95% CI: −1.04 to −.24) for depression; t(28)=−3.12, p=.002, d=−.58 (95% CI: −.97 to −.18) for anxiety; t(28)=−2.77, p=.005, d=−.52 (95% CI: −.90 to −.12) for anger; and t(28)=−3.26, p=.001, d=−.61 (95% CI: −1.00 to −.21) for perceived stress. In contrast, no significant changes in parent-reported symptoms were observed in the WI group: t(24)=−1.02, p=.16, d=−.20 (95% CI: −.60 to .19) for depression; t(24) =−.93, p=.18, d=−.19 (95% CI: −.58 to .21) for anxiety; t(24)=−.75, p=.23, d=−.15 (95% CI: −.54 to .25) for anger; and t(24)=−.27, p=.40, d=−.05 (95% CI: −.45 to .34) for perceived stress.
Intention-to-Treat Analyses
Results of intention-to-treat analyses using mixed-design ANOVAs with REML were generally consistent with analyses with intervention completers. The group × time interaction for parent-reported child perceived stress remained significant, F(1,64.41)=7.55, p=.01. The group x time interactions for parent-reported child anger, F(1,63.16)=7.41, p=.01, anxiety, F(1,57.23)=9.52, p<.01, depression F(1,57.08)=11.35, p<.01, and child-reported anxiety F(1,58.75)=5.12, p=.03, all reached significance. Effects of time on parent-reported child anger, anxiety, and depression were all significant in the FPPE group (ps<.01) with no significant change in the WI group (ps>.26). There was a trend for an increase in daily positive affect in the FPPE group (p = .09) but not WI (p=.92).
Discussion
The goal of this multi-method study was to conduct a preliminary RCT of an RDoC- and neuroscience-informed preventive intervention targeting PVS in children of mothers with elevated depressive symptoms. Results indicated that FPPE, an 8-week dyadic positive emotion focused intervention administered virtually, produced high satisfaction ratings for both mothers and children, supporting its tolerability in families. At the between-subjects level, we found few significant differences in clinical and PVS outcomes between youth assigned to FPPE versus WI, likely due to the relatively small sample. At the within-subjects level, FPPE was associated with increases in child-reported daily positive affect, offering preliminary support of PVS target engagement, but no effects of FPPE on enhancing reinforcement learning were observed. FPPE was also associated with reductions in symptoms of depression, anxiety, anger, and perceived stress in children at risk for depression, with medium to large effects in within-subjects analyses. Symptom changes were only apparent for parent report of child symptoms rather than child-reported symptoms. Together, this study provides initial, preliminary support for the acceptability, feasibility, and utility of a dyadic positive affect-focused intervention for preventing the emergence of emotional distress symptoms in HR youth.
Consistent with an experimental therapeutics approach to prevention, FPPE is expected to exert its effects in preventing the development of children’s psychological symptoms via increasing PVS function. Surprisingly, we did not find evidence of significant between-subjects effects on PVS measures in this preliminary trial, likely due to the relatively small sample, but within-subjects comparisons indicated that FPPE was associated with increases in daily positive affect in at-risk youth with a small effect size. In contrast, positive affect remained stable in youth assigned to psychoeducation. Importantly, treatments for depression tend to have more limited effects on increasing positive affect than decreasing negative affect (Dunn et al., 2020), so this pattern of results for FPPE is particularly promising. Further, these findings were observed using daily survey over 10 days, supporting the potential utility of FPPE to produce changes in real-world experiences of positive affect. Contrary to our hypotheses, FPPE had no effect on enhancing behavioral measures of reinforcement learning. Given mixed findings regarding whether HR youth show altered behavioral performance on the probabilistic reward task (Luking et al., 2015; Morris et al., 2015), one possibility is that HR youth in the current sample already demonstrated intact behavioral reward learning processes at baseline. It is important to note that although this task has been used with children in prior research, it did appear to be quite challenging for many children and may not be the most reliable measure of reward learning for younger children. It is also possible that FPPE may exert its effects through other PVS components, such as reward anticipation and responsiveness. Indeed, the intervention was inspired from neuroimaging and EEG research documenting that HR offspring exhibit alterations in brain and electrocortical correlates of reward anticipation and consumption (Burkhouse & Kujawa, 2023; Kujawa & Burkhouse, 2017). These measures were not included in this initial validation study due to limited funds and because FPPE was delivered to families virtually. Thus, an important next step will be to test whether FPPE enhances PVS function across other brain-behavioral measures, and whether these changes, in turn, result in the prevention of emotional disorders and stress sensitivity in HR youth.
Next, it is notable that the observed changes, other than daily positive affect, were most evident for maternal reports of child symptoms. Although it is common for different informants to disagree with one another, especially in reports of internalizing symptoms (De Los Reyes & Kazdin, 2005), an important next step will be to incorporate other measures of affect and symptoms, such as diagnostic interviews and observable positive affect using parent-child interaction tasks. Given evidence that social desirability increases with age (Soubelet & Salthouse, 2011), one possibility is that mothers may have been more prone to social desirability effects for intervention outcomes than children. This pattern of distinct patterns of change for parent- and child-reported symptoms, however, is consistent with other prevention studies. For example, there is evidence that child-reported changes in internalizing symptoms with preventive interventions become more apparent at later stages of longitudinal follow-ups, suggesting it may take more time for them to emerge (Compas et al., 2009). Although it is promising that we are seeing immediate effects for FPPE with parent-reported assessments and daily assessments of positive affect with children, a critical next step will be to incorporate longitudinal follow-ups to evaluate the robustness of these effects over time as families practice and use positive emotion skills in the real world.
In these preliminary results, targeting PVS processes in HR children was associated with decreases in child symptoms post-intervention. Although it is encouraging that FPPE produced immediate effects in HR youth who were not exhibiting elevated clinical symptoms at baseline, replication trials with larger sample sizes are required to reliably estimate effect sizes for this prevention program. Moreover, it will be important for future studies to evaluate how FPPE compares to other established prevention programs for youth at high risk for depression, which tend to show small-to-medium effects at the between-subjects level (for reviews, Gladstone & Beardslee, 2009; Loechner et al., 2018; Rishel, 2012). It is also noteworthy that FPPE exerted the strongest effects for changes in parent-reported perceived stress among HR offspring. This finding is consistent with increasing evidence that reduced activation of PVS plays a key role in the effects of stress on psychopathology (Kujawa, Klein, et al., 2020; Pizzagalli, 2014). FPPE may exert its immediate effect on child’s stress responses through targeting PVS processes, and clinical effects may become more apparent over time through reductions in perceived stress.
There are many strengths to this study, including a novel prevention program for HR youth inspired by affective neuroscience that demonstrated good tolerability and satisfaction with families, and an RDoC-informed multi-method approach to examining outcomes. Some limitations also warrant additional research. First, the grant proposal and associated protocol registered on clinicaltrials.gov focused exclusively on child outcomes. FPPE was designed as a dyadic intervention, and many of the skills focus on increasing attention to and the salience of positive aspects of dyads’ environments and relationships. Thus, a critical next step will be to evaluate how FPPE impacts mothers’ PVS processes and symptoms, and how these maternal changes, in turn, may influence the child. Second, moving toward more personalized prevention approaches, future research with larger samples will be important for examining whether certain families may benefit most from FPPE (e.g., at-risk offspring exhibiting greater deficits in PVS function may be more likely to benefit versus those with intact reward processing at baseline). Moreover, most parents in the study were highly educated, incomes were relatively high, and the sample was limited in racial and ethnic diversity. It will be important for future FPPE efficacy studies to include larger economically and racially diverse samples. In this initial validation study, mothers with at least mild depressive symptoms at baseline were included. On average, mothers were experiencing moderate levels of depressive symptoms that were above the suggested cut-off for diagnosing major depression using the PHQ-9 (Levis et al., 2020; Moriarty et al., 2015). Nonetheless, diagnostic assessments in future studies are needed to evaluate generalizability and determine whether MDD characteristics (e.g., timing, severity, chronicity) impact response rates to FPPE. Next, although FPPE produced high satisfaction ratings, there was a higher level of attrition in FPPE compared to WI. Although most FPPE dropouts happened prior to the initial session and were likely attributed to time demands and scheduling difficulties, disproportional drop-out rates threaten the validity of the study. In future research, it will be important to test a comparison intervention with similar time demands and scheduling expectations to minimize group differences in attrition or to use alternative randomization approaches to account for higher drop-out in the active intervention group. It will also be important to stratify based on key variables, like positive affect, to ensure an even distribution at baseline. In addition, future research is needed to investigate predictors of FPPE dropout to ensure it is feasible and acceptable for families from diverse backgrounds. Moreover, the trial focused exclusively on mother-child dyads given prior evidence linking maternal depression to alterations in child PVS function (Burkhouse & Kujawa, 2023). Paternal depression is also associated with emotional and behavioral problems in offspring (Sweeney & MacBeth, 2016), and a critical next step will be to evaluate the efficacy of FPPE with other caregivers. Lastly, limitations to the study design precluded our ability to draw firm conclusions on the efficacy of FPPE, including the lack of clinical measures at each session, longitudinal follow-ups, and clinician-administered interviews to assess child psychopathology. Although participants completed intervention satisfaction forms, we did not systematically collect data on treatment credibility and expectancy or homework compliance. Future work incorporating these assessments and neural indices of PVS function is needed to fully evaluate FPPE’s long-term efficacy, its potential target mechanisms, and further understanding of when and how the intervention exerts its effects.
Given that PVS deficits are implicated in an array of psychopathologies (Kujawa, Klein, et al., 2020), our goal is to refine FPPE to be an efficient, feasible, and engaging intervention that may be combined with other interventions for a transdiagnostic and more generalizable approach to prevention. Indeed, we see preliminary evidence that FPPE may be effective in preventing symptoms of anxiety, depression, and perceived stress. Research suggests shorter prevention programs may produce larger effect sizes (Stice et al., 2009); therefore, an important next step will be to evaluate how many sessions are required to engage and modify PVS processes and whether it may be delivered in a shorter format. In addition to a standalone prevention program, FPPE could be offered as an add-on preventive intervention for youth with early markers of low PVS function to enhance intervention response rates. This precision medicine approach targeting functional domains of behaviors may ultimately lead to improved adherence and outcomes by meeting the individual needs of children at risk and their families.
Conclusion
This preliminary study provides support for the feasibility and acceptability of a dyadic RDoC-informed preventive intervention targeting PVS processes in children of mothers with elevated depressive symptoms. Reductions in parent-reported symptoms of emotional distress and perceived stress and improvements in daily child-reported positive affect were observed post-intervention among HR youth in FPPE relative to psychoeducation, although some effects were only present in within-subjects analyses. The current study takes the first, preliminary step in translating links between low PVS function and depression risk to prevention and offers a proof-of-concept for applying neuroscience and the RDoC framework to advance interventions for vulnerable youth.
Acknowledgements
This research was supported by a John and Polly Sparks Early Career Grant from the American Psychological Foundation to A.K., Peabody Small Grant from Vanderbilt University to A.K., and in part by UL1 TR000445 from NCATS. Study funders were not involved in the trial design, implementation of the project, or analysis/interpretation of results. K.L.B. was supported by NIMH K23-MH113793, M.G. and C.F. were supported by NIMH T32-MH067631, S.P. and K.E.H. were supported by NIMH T32-MH18921, S.P. was supported by NIMH F31-MH127817, and L.D. was supported by NIMH F31-MH127863.
Abbreviations:
- FPPE
Family Promoting Positive Emotions
- WI
Written Information
- RDoC
Research Domain Criteria
- PVS
Positive Valence Systems
- HR
High-Risk
Footnotes
Declaration of Interest Statement
The authors report there are no competing interests to declare.
We planned to enroll 25 participants per group in this pilot RCT for feasibility given limited funding and based on power analyses which indicated .80 power to detect medium within-subjects effects. We over-enrolled to account for attrition and stopped recruitment when we were confident that we would have a minimum of 25 intervention completers in each group.
We initially planned to enroll only mothers reporting elevated COVID-19-related stressors on the Pandemic Stress Questionnaire (Kujawa, Green, et al., 2020); however, due to the changing nature of the pandemic and challenges with assessment, we removed this criterion and enrolled all mothers otherwise eligible regardless of stressor endorsement.
Due to higher drop out in the FPPE group, the targeted sample size for WI was obtained prior to meeting recruitment goals for FPPE and block sizes were adjusted so that the likelihood of being assigned to FPPE was 75-100% towards the end of the study.
In cases where the family did not complete the homework, the skills coach reviewed the assigned homework skill(s) with the family using examples from the mother and child’s week.
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