Project Relate: Romantic Relationship Competence SSI

NCT05722574 | Unknown

• 1 other identifier: IRB2022-00262
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Relational Problems; Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-SSI to 3-month follow-up

Secondary Outcomes (6)

• Beck Hopelessness Scale - 4 Item Version (Steed, 2001)

  Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up

• Relationship Learning Inventory (Davila et al., 2000)

  Pre-Intervention to Immediately Post-Intervention

• Generalized Anxiety Disorder (GAD-7; Steed, 2001)

  Pre-SSI to 3-month follow-up

• Relationship Decision Making Scale (Vennum & Fincham, 2011)

  Pre-SSI to 3-month follow-up

• Relationship Knowledge and Efficacy Scale (Davila et al., 2020)

  Pre-SSI to 3-month follow-up

Other Outcomes (6)

• UCLA Loneliness Scale

  Pre-SSI to 3-month follow-up

• Perceived Changes

  Immediately Post-Intervention

• Program Feedback Scale

  Pre-Intervention to Immediately Post-Intervention

Study Arms (2)

Information Only Control Condition

ACTIVE COMPARATOR

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

Romantic Competence Intervention

EXPERIMENTAL

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

Interventions

Romantic Competence Intervention BEHAVIORAL

Online, 30-minute self-administered relationship competence program for youth ages 16-20

Romantic Competence Intervention

Information Only Control Condition BEHAVIORAL

Online, 30-minute self-administered relationship education activity for youth ages 16-20

Information Only Control Condition

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 \[PHQ-2\])

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Related Publications (12)

• 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.

  PMID: 25524788 BACKGROUND

• 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.

  PMID: 32929399 BACKGROUND

• 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.

  PMID: 28117056 BACKGROUND

• 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.

  PMID: 32391709 BACKGROUND

• 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.

  PMID: 34887544 BACKGROUND

• 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.

  PMID: 21697139 BACKGROUND

• 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.

  PMID: 25679324 BACKGROUND

• 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.

  PMID: 27918174 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jessica Schleider, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Schleider, PhD

CONTACT

(631) 632-4131; jessica.schleider@stonybrook.edu

Atina Manvelian, PhD

CONTACT

atina.manvelian@stonybrook.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized to either the intervention condition or the information-only control group.

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: February 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Deidentified data will be made available on the Open Science Framework within one year of publishing study results.
• Access Criteria: Access will not be restricted.