Clinical trial NCT05722574: Project Relate: Romantic Relationship Competence SSI
Official title: Project Relate: Romantic Relationship Competence Single-Session Intervention Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Relational Problems
Depression
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the intervention condition or the information-only control group.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
timeFrame: Pre-SSI to 3-month follow-up
Secondary outcomes:
measure: Beck Hopelessness Scale - 4 Item Version (Steed, 2001)
timeFrame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
measure: Relationship Learning Inventory (Davila et al., 2000)
timeFrame: Pre-Intervention to Immediately Post-Intervention
measure: Generalized Anxiety Disorder (GAD-7; Steed, 2001)
timeFrame: Pre-SSI to 3-month follow-up
measure: Relationship Decision Making Scale (Vennum & Fincham, 2011)
timeFrame: Pre-SSI to 3-month follow-up
measure: Relationship Knowledge and Efficacy Scale (Davila et al., 2020)
timeFrame: Pre-SSI to 3-month follow-up
measure: Qualitative Changes in the Relationship Learning Inventory
timeFrame: Immediately Post-Intervention
Other outcomes:
measure: UCLA Loneliness Scale
timeFrame: Pre-SSI to 3-month follow-up
measure: Perceived Changes
timeFrame: Immediately Post-Intervention
measure: Program Feedback Scale
timeFrame: Pre-Intervention to Immediately Post-Intervention
measure: Global/General Attachment (ECR-RS, 9-item Version; Fraley et al., 2015)
timeFrame: Pre-SSI to 3-month follow-up
measure: Interpersonal Reactivity Index (Peloquin & Lafontaine, 2010).
timeFrame: Pre-SSI to 3-month follow-up
measure: Couple Satisfaction Index (CSI-4; Funk & Rogge, 2007).
timeFrame: Pre-SSI to 3-month follow-up
Locations:
Study officials:
affiliation: Stony Brook University
name: Jessica Schleider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.
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.
citation: 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.
citation: 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.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Davila J, Zhou J, Norona J, Bhatia V, Mize L, Lashman K. Teaching romantic competence skills to emerging adults: A relationship education workshop. Pers Relatsh. 2021;28(2):251-275. doi:10.1111/pere.12366
citation: Davila J, Mattanah J, Bhatia V, et al. Romantic competence, healthy relationship functioning, and well-being in emerging adults. Pers Relatsh. 2017;24(1):162-184. doi:10.1111/pere.12175
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.