Project Relate: Romantic Relationship Competence SSI

Sponsor
Stony Brook University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05722574
Collaborator
(none)
500
2
4.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Romantic Competence Intervention
  • Behavioral: Information Only Control Condition
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized to either the intervention condition or the information-only control group.Participants will be randomized to either the intervention condition or the information-only control group.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Project Relate: Romantic Relationship Competence Single-Session Intervention Trial
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Information Only Control Condition

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.

Behavioral: Information Only Control Condition
Online, 30-minute self-administered relationship education activity for youth ages 16-20

Experimental: Romantic Competence Intervention

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.

Behavioral: Romantic Competence Intervention
Online, 30-minute self-administered relationship competence program for youth ages 16-20

Outcome Measures

Primary Outcome Measures

  1. Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) [Pre-SSI to 3-month follow-up]

    The PHQ-9 is a reliable, valid measure of depression symptom severity. Higher scores indicate more severe symptoms of depression.

Secondary Outcome Measures

  1. Beck Hopelessness Scale - 4 Item Version (Steed, 2001) [Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up]

    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.

  2. Relationship Learning Inventory (Davila et al., 2000) [Pre-Intervention to Immediately Post-Intervention]

    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.

  3. Generalized Anxiety Disorder (GAD-7; Steed, 2001) [Pre-SSI to 3-month follow-up]

    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.

  4. Relationship Decision Making Scale (Vennum & Fincham, 2011) [Pre-SSI to 3-month follow-up]

    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.

  5. Relationship Knowledge and Efficacy Scale (Davila et al., 2020) [Pre-SSI to 3-month follow-up]

    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.

  6. Qualitative Changes in the Relationship Learning Inventory [Immediately Post-Intervention]

    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.

Other Outcome Measures

  1. UCLA Loneliness Scale [Pre-SSI to 3-month follow-up]

    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.

  2. Perceived Changes [Immediately Post-Intervention]

    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).

  3. Program Feedback Scale [Pre-Intervention to Immediately Post-Intervention]

    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.

  4. Global/General Attachment (ECR-RS, 9-item Version; Fraley et al., 2015) [Pre-SSI to 3-month follow-up]

    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.

  5. Interpersonal Reactivity Index (Peloquin & Lafontaine, 2010). [Pre-SSI to 3-month follow-up]

    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.

  6. Couple Satisfaction Index (CSI-4; Funk & Rogge, 2007). [Pre-SSI to 3-month follow-up]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Stony Brook University

Investigators

  • Principal Investigator: Jessica Schleider, PhD, Stony Brook University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jessica Schleider, Assistant Professor, Stony Brook University
ClinicalTrials.gov Identifier:
NCT05722574
Other Study ID Numbers:
  • IRB2022-00262
First Posted:
Feb 10, 2023
Last Update Posted:
Feb 14, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2023