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Project Relate: Romantic Relationship Competence SSI

Primary Purpose

Relational Problems, Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Romantic Competence Intervention
Information Only Control Condition
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relational Problems

Eligibility Criteria

16 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: are fluent in English have consistent internet and computer/laptop/smartphone access report elevated depressive symptoms (a score of >2 on the Patient Health Questionnaire-2 item version [PHQ-2]) Exclusion Criteria: fail to meet the above-listed inclusion criteria exit the study prior to condition randomization respond with either copy/pasted responses from text earlier in the intervention to any of free response questions obvious lack of English fluency in open response questions responding with random text in open response questions duplicate responses from the same individual in baseline or follow-up surveys

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Information Only Control Condition

    Romantic Competence Intervention

    Arm Description

    The information only control condition is designed to mimic relationship education that could be easily found online by adolescents. This condition does not teach romantic competence skills such as insight, communication/mutuality, or emotion regulation skills; rather, it focuses on educating subjects about the healthy and unhealthy signs of a romantic relationship. In addition, this condition is designed to control for nonspecific aspects of the intervention, such as engaging in an online program and taking time to reflect on one's relationships.

    The Romantic Competence Single-Session Intervention provides adolescents with the opportunity to learn one of three relational skills online: (1) Insight, the ability to understand what one needs in relationships and act in alignment with one's needs, (2) Communication, the capacity to listen to others and express one's needs effectively, and (3) Stay vs. Go, the ability to reflect and make difficult decisions in relationships. Adolescents are presented with the opportunity to choose which module they would like to complete. Each module has the following components: psychoeducation, a personalized action plan, and practice overcoming barriers.

    Outcomes

    Primary Outcome Measures

    Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
    The PHQ-9 is a reliable, valid measure of depression symptom severity. Higher scores indicate more severe symptoms of depression.

    Secondary Outcome Measures

    Beck Hopelessness Scale - 4 Item Version (Steed, 2001)
    This scale asks participants to rate 4 statements based on their sense of hopelessness. Participants rate the 4 statements on a 4 point scale ranging from 0 (Absolutely Disagree) to 3 (Absolutely Agree). Average scores across all items range from 0 to 3, with a higher score indicating greater levels of hopelessness.
    Relationship Learning Inventory (Davila et al., 2000)
    This measure uses 3 questions post-intervention to assess the extent to which participants gained learned something important after the activity, thought about relationships differently, or felt validated in the way that they have been thinking/acting in their relationships.
    Generalized Anxiety Disorder (GAD-7; Steed, 2001)
    The GAD-7 measures the severity of clinical anxiety symptoms, based on diagnostic criteria for generalized anxiety disorder. The GAD-7 includes 7 items asking respondents how often, during the last 2 weeks, they were bothered by each of 7 anxiety symptoms. Higher scores reflect higher generalized anxiety symptoms.
    Relationship Decision Making Scale (Vennum & Fincham, 2011)
    The Relationship Deciding Scale measures effective decision-making during interpersonal situations. It has three subscales with items rated on a 5- point scale (1 = strongly disagree, 5 = strongly agree), relationship confidence, assessing confidence in maintaining a relationship; warning signs, assessing awareness of and ability to deal with warning signs in relationships; and deciding, assessing thoughtfulness regarding decisions. Higher scores suggest more effective decision-making.
    Relationship Knowledge and Efficacy Scale (Davila et al., 2020)
    This measure consists of 21 items, rated 1-7 (1 = strongly disagree, 7 = strongly agree), and measures six domains: (1) confidence in one's knowledge about what a healthy relationship is and ability to manage relationships; (2) confidence in one's knowledge about and ability to cope with relationship problems; (3) willingness to compromise oneself; (4) beliefs that any relationship can work if you work hard enough; and (5) overreliance on emotions for relationship decisions. Higher scores reflect better relationship knowledge and efficacy.
    Qualitative Changes in the Relationship Learning Inventory
    Immediately after the activity, participants will be asked, "In your opinion, what was the most important thing you learned from this activity?" "Based on what you learned, will you do anything differently in your relationships? If yes, please elaborate on what you will do differently." At the 3-month follow-up, we also ask two additional questions, "From what you remember, what was the most important thing you learned in our relationship education activity?" and "Since completing this activity, have you noticed any changes in how you navigate your relationships? If yes, please tell us what you have noticed." Participants are provided with space to answer these questions via text entry.

    Full Information

    First Posted
    February 1, 2023
    Last Updated
    February 10, 2023
    Sponsor
    Stony Brook University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05722574
    Brief Title
    Project Relate: Romantic Relationship Competence SSI
    Official Title
    Project Relate: Romantic Relationship Competence Single-Session Intervention Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stony Brook University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The COVID-19 pandemic has increased social isolation and depressive symptoms in youth, adding strain to an already overwhelmed mental healthcare system. Online single-session interventions are digital programs that can help expand access to care and teach evidence-based skills. To help youth build healthy relationships, we developed 3 online single-session interventions (SSI) to teach romantic competence skills to adolescents and emerging adults. Youth, ages 16-20, will be recruited to social media and randomly assigned to one of two conditions: the intervention condition, offering them three SSIs to select from, or an information-only control group. Within the intervention condition, youth will complete one of three romantic competence SSIs: (1) Insight, targeting awareness of one's needs in relationships, (2) Communication, teaching listening and communication skills, and (3) Stay vs. Go, helping youth make difficult decisions. Investigators will assess each SSI's relative benefits on relationship knowledge and depressive symptoms up to three months later compared to the information-only control group. Results will reveal if online SSIs can teach romantic competence skills and if engaging in these interventions has psychosocial benefits for youth with elevated depressive symptoms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Relational Problems, Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomized to either the intervention condition or the information-only control group.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Information Only Control Condition
    Arm Type
    Active Comparator
    Arm Description
    The information only control condition is designed to mimic relationship education that could be easily found online by adolescents. This condition does not teach romantic competence skills such as insight, communication/mutuality, or emotion regulation skills; rather, it focuses on educating subjects about the healthy and unhealthy signs of a romantic relationship. In addition, this condition is designed to control for nonspecific aspects of the intervention, such as engaging in an online program and taking time to reflect on one's relationships.
    Arm Title
    Romantic Competence Intervention
    Arm Type
    Experimental
    Arm Description
    The Romantic Competence Single-Session Intervention provides adolescents with the opportunity to learn one of three relational skills online: (1) Insight, the ability to understand what one needs in relationships and act in alignment with one's needs, (2) Communication, the capacity to listen to others and express one's needs effectively, and (3) Stay vs. Go, the ability to reflect and make difficult decisions in relationships. Adolescents are presented with the opportunity to choose which module they would like to complete. Each module has the following components: psychoeducation, a personalized action plan, and practice overcoming barriers.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Romantic Competence Intervention
    Intervention Description
    Online, 30-minute self-administered relationship competence program for youth ages 16-20
    Intervention Type
    Behavioral
    Intervention Name(s)
    Information Only Control Condition
    Intervention Description
    Online, 30-minute self-administered relationship education activity for youth ages 16-20
    Primary Outcome Measure Information:
    Title
    Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
    Description
    The PHQ-9 is a reliable, valid measure of depression symptom severity. Higher scores indicate more severe symptoms of depression.
    Time Frame
    Pre-SSI to 3-month follow-up
    Secondary Outcome Measure Information:
    Title
    Beck Hopelessness Scale - 4 Item Version (Steed, 2001)
    Description
    This scale asks participants to rate 4 statements based on their sense of hopelessness. Participants rate the 4 statements on a 4 point scale ranging from 0 (Absolutely Disagree) to 3 (Absolutely Agree). Average scores across all items range from 0 to 3, with a higher score indicating greater levels of hopelessness.
    Time Frame
    Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
    Title
    Relationship Learning Inventory (Davila et al., 2000)
    Description
    This measure uses 3 questions post-intervention to assess the extent to which participants gained learned something important after the activity, thought about relationships differently, or felt validated in the way that they have been thinking/acting in their relationships.
    Time Frame
    Pre-Intervention to Immediately Post-Intervention
    Title
    Generalized Anxiety Disorder (GAD-7; Steed, 2001)
    Description
    The GAD-7 measures the severity of clinical anxiety symptoms, based on diagnostic criteria for generalized anxiety disorder. The GAD-7 includes 7 items asking respondents how often, during the last 2 weeks, they were bothered by each of 7 anxiety symptoms. Higher scores reflect higher generalized anxiety symptoms.
    Time Frame
    Pre-SSI to 3-month follow-up
    Title
    Relationship Decision Making Scale (Vennum & Fincham, 2011)
    Description
    The Relationship Deciding Scale measures effective decision-making during interpersonal situations. It has three subscales with items rated on a 5- point scale (1 = strongly disagree, 5 = strongly agree), relationship confidence, assessing confidence in maintaining a relationship; warning signs, assessing awareness of and ability to deal with warning signs in relationships; and deciding, assessing thoughtfulness regarding decisions. Higher scores suggest more effective decision-making.
    Time Frame
    Pre-SSI to 3-month follow-up
    Title
    Relationship Knowledge and Efficacy Scale (Davila et al., 2020)
    Description
    This measure consists of 21 items, rated 1-7 (1 = strongly disagree, 7 = strongly agree), and measures six domains: (1) confidence in one's knowledge about what a healthy relationship is and ability to manage relationships; (2) confidence in one's knowledge about and ability to cope with relationship problems; (3) willingness to compromise oneself; (4) beliefs that any relationship can work if you work hard enough; and (5) overreliance on emotions for relationship decisions. Higher scores reflect better relationship knowledge and efficacy.
    Time Frame
    Pre-SSI to 3-month follow-up
    Title
    Qualitative Changes in the Relationship Learning Inventory
    Description
    Immediately after the activity, participants will be asked, "In your opinion, what was the most important thing you learned from this activity?" "Based on what you learned, will you do anything differently in your relationships? If yes, please elaborate on what you will do differently." At the 3-month follow-up, we also ask two additional questions, "From what you remember, what was the most important thing you learned in our relationship education activity?" and "Since completing this activity, have you noticed any changes in how you navigate your relationships? If yes, please tell us what you have noticed." Participants are provided with space to answer these questions via text entry.
    Time Frame
    Immediately Post-Intervention
    Other Pre-specified Outcome Measures:
    Title
    UCLA Loneliness Scale
    Description
    The ULS is a widely used self-report scale of loneliness. The brief 3-item version will be used here. Participants will rate agreement with 3 items reflecting loneliness (e.g. "I feel left out"; "I feel isolated from others"). Higher scores reflect higher levels of loneliness.
    Time Frame
    Pre-SSI to 3-month follow-up
    Title
    Perceived Changes
    Description
    Participants are asked 3 questions about perceived changes in mood, hopelessness, and problem-solving capabilities. "Compared to before doing this activity, to what extent are you feeling hopeless right now?" Items are rated 1-5 (1 = much more hopeless, 5 = much less hopeless). Compared to before doing this activity, what is your mood like right now?" Items are rated 1-5 (1 = much worse, 5 = much better). "Compared to before doing this activity, to what extent are you able to solve the problems facing you right now?" Items are rated 1-5 (1 = much less able to solve problems, 5 = a lot more able to solve problems).
    Time Frame
    Immediately Post-Intervention
    Title
    Program Feedback Scale
    Description
    The PFS asks youth to rate agreement with 7 statements indicating perceived acceptability of an SSI (e.g. "I enjoyed the program") on a 5-point Likert scale (1="really disagree"; 5="totally agree"). A score of 3.5/5 or above on any given PFS item is interpreted as an "acceptable" rating on that item. Scores are calculated at the item-level, and higher scores reflect greater acceptability for each item.
    Time Frame
    Pre-Intervention to Immediately Post-Intervention
    Title
    Global/General Attachment (ECR-RS, 9-item Version; Fraley et al., 2015)
    Description
    The Relationship Structures Questionnaire is a self-report measure that assesses general attachment patterns across a variety of close relationships. It asks participants to rate the extent to which each statement describes their feelings about close relationships in general. This abbreviated measure consists of 9 items, ranking from 1 (Strongly Disagree) to 7 (Strongly Agree). This measure consists of two subscales: anxiety and avoidance. Higher scores on the anxiety and avoidance subscales represent higher levels of attachment insecurity.
    Time Frame
    Pre-SSI to 3-month follow-up
    Title
    Interpersonal Reactivity Index (Peloquin & Lafontaine, 2010).
    Description
    We assessed empathy and perspective-taking with the two subscales of the Interpersonal Reactivity Index (IRIC; Péloquin & Lafontaine; 2010); this measure was only administered to youth who were dating or in a committed romantic relationship. Items rated on a 5-point scale (0 = does not describe me well, 4 = describes me very well). Example items for perspective taking include, "When I'm upset at my partner, I usually try to 'put myself in his/her shoes' for a while" and empathic concern, " I often have tender, concerned feelings for my partner when he/she is less fortunate than me." Participants were instructed to 'Answer about your current or most recent partner,' and higher scores reflect higher levels of empathy and perspective-taking, respectively.
    Time Frame
    Pre-SSI to 3-month follow-up
    Title
    Couple Satisfaction Index (CSI-4; Funk & Rogge, 2007).
    Description
    We used the 4-item measure from the Couple Satisfaction Index to measure relationship satisfaction; this measure was administered to youth who were dating or in a committed romantic relationship. Items include questions like "How rewarding is your relationship with your partner?" and "In general, how satisfied are you with your relationship?" Items are ranked 0- Not at all to 5- Completely. CSI-4 scores can range from 0 to 21. Higher scores indicate higher levels of relationship satisfaction.
    Time Frame
    Pre-SSI to 3-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: are fluent in English have consistent internet and computer/laptop/smartphone access report elevated depressive symptoms (a score of >2 on the Patient Health Questionnaire-2 item version [PHQ-2]) Exclusion Criteria: fail to meet the above-listed inclusion criteria exit the study prior to condition randomization respond with either copy/pasted responses from text earlier in the intervention to any of free response questions obvious lack of English fluency in open response questions responding with random text in open response questions duplicate responses from the same individual in baseline or follow-up surveys
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jessica Schleider, PhD
    Phone
    (631) 632-4131
    Email
    jessica.schleider@stonybrook.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Atina Manvelian, PhD
    Email
    atina.manvelian@stonybrook.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jessica Schleider, PhD
    Organizational Affiliation
    Stony Brook University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    After our trial has ended, data without any identifying markers will be made available to researchers interested in our dataset.
    IPD Sharing Time Frame
    Deidentified data will be made available on the Open Science Framework within one year of publishing study results.
    IPD Sharing Access Criteria
    Access will not be restricted.
    Citations:
    PubMed Identifier
    25524788
    Citation
    Avenevoli S, Swendsen J, He JP, Burstein M, Merikangas KR. Major depression in the national comorbidity survey-adolescent supplement: prevalence, correlates, and treatment. J Am Acad Child Adolesc Psychiatry. 2015 Jan;54(1):37-44.e2. doi: 10.1016/j.jaac.2014.10.010. Epub 2014 Oct 29.
    Results Reference
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    PubMed Identifier
    32929399
    Citation
    Marques de Miranda D, da Silva Athanasio B, Sena Oliveira AC, Simoes-E-Silva AC. How is COVID-19 pandemic impacting mental health of children and adolescents? Int J Disaster Risk Reduct. 2020 Dec;51:101845. doi: 10.1016/j.ijdrr.2020.101845. Epub 2020 Sep 10.
    Results Reference
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    PubMed Identifier
    28117056
    Citation
    Schleider JL, Weisz JR. Little Treatments, Promising Effects? Meta-Analysis of Single-Session Interventions for Youth Psychiatric Problems. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):107-115. doi: 10.1016/j.jaac.2016.11.007. Epub 2016 Nov 25.
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    Citation
    Osborn TL, Rodriguez M, Wasil AR, Venturo-Conerly KE, Gan J, Alemu RG, Roe E, Arango G S, Otieno BH, Wasanga CM, Shingleton R, Weisz JR. Single-session digital intervention for adolescent depression, anxiety, and well-being: Outcomes of a randomized controlled trial with Kenyan adolescents. J Consult Clin Psychol. 2020 Jul;88(7):657-668. doi: 10.1037/ccp0000505. Epub 2020 May 11.
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    PubMed Identifier
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    Schleider JL, Mullarkey MC, Fox KR, Dobias ML, Shroff A, Hart EA, Roulston CA. A randomized trial of online single-session interventions for adolescent depression during COVID-19. Nat Hum Behav. 2022 Feb;6(2):258-268. doi: 10.1038/s41562-021-01235-0. Epub 2021 Dec 9.
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    PubMed Identifier
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    Citation
    Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.
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    Zhang WC, Jia CX, Hu X, Qiu HM, Liu XC. Beck Hopelessness Scale: Psychometric Properties Among Rural Chinese Suicide Attempters and Non-Attempters. Death Stud. 2015;39(7):442-6. doi: 10.1080/07481187.2014.970300. Epub 2015 Feb 13.
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    Ahlen J, Ghaderi A. Evaluation of the Children's Depression Inventory-Short Version (CDI-S). Psychol Assess. 2017 Sep;29(9):1157-1166. doi: 10.1037/pas0000419. Epub 2016 Dec 5.
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