Empowering Economically Insecure Parents to Manage Child Anxiety

NCT05990322 | Unknown

• 1 other identifier: 00195
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Efforts to develop and disseminate evidence based practices (EBPs) for youth anxiety have made great strides. Still, up to 82.2% of youth who need mental health treatment for anxiety never access care or drop out prematurely; commonly cited barriers to treatment are shortage of care, transportation limitations, financial burden, and gatekeeping behaviors by caretakers. As such, there is great need for accessible, scalable interventions that can ameliorate the global burden of youth anxiety, including those that help prevent the onset of anxiety in high-risk children. Single session interventions (SSIs), which have prevented and reduced child anxiety across numerous trials to date, may offer a promising solution, given their potential disseminability and cost-effectiveness. The proposed randomized trial will evaluate the effects of a novel, web-based, self-guided SSI designed to systematically reduce parent accommodation in economically insecure parents.

Conditions

Project EMPOWER; Online Resources and Referrals

Outcome Measures

Primary Outcomes (2)

• Family Accommodation Scale

  Family Accommodation Scale is a 9-item measure designed to assess the extent a caregiver accommodate a child's anxiety symptoms; example questions include: "how often did you assist your child in avoiding things that might make him/her more anxious?" and "have you modified your family routine because of your child's symptoms?" Items are rated from 0 (never) to 4 (daily). Scores range from 0-36 with higher scores indicating more frequent parental accommodation

  Change from Baseline to 2-week and 4-week follow up

• Perceived pre-to-post SSI change

  This two-item measure assesses participants' perceived change in their ability to help their children manage distressing situations and their ability to provide validation to their children from pre- to post-SSI. Parents in both groups will rate this question on a 5-point scale of 1 (much less able) to 5 (much more able).

  Immediately after the SSI

Secondary Outcomes (9)

• Distress Tolerance Scale

  Change from Baseline to 2-week and 4-week follow up

• Program Feedback Scale

  Immediately after the SSI

• Penn State Worry Questionnaire

  Baseline

• Consumer Financial Protection Bureau Financial Well-Being Scale

  Baseline

• Brief SPENCE Children's Anxiety Scale

  Change from baseline to 4-week follow-up

Study Arms (2)

Project EMPOWER

EXPERIMENTAL

Project EMPOWER is a web-based, self-administered SSI for parents that takes about 30 minutes to complete. The program includes 5 elements, based on current best-practices in SSI design (Schleider, Dobias, Sung, \& Mullarkey, 2020) and existing interventions targeting accommodation (Lebowitz \& Omer, 2014): (1) an introduction to the program's rationale; (2) psychoeducation around child anxiety and avoidance, along with how parental accommodation can inadvertently maintain child anxiety; (3) information on how parents can better identify children's patterns of avoidance and encourage brave behavior instead; (4) facilitating parents' creation of an "action plan" for promoting brave behavior and reduce avoidance in their own child; (5) a vignette exercise in which parents read about another family's difficulty managing their child's anxiety; parents identify the elements of the anxiety cycle and provide possible solutions to these parents based on what they learned.

Behavioral: Project EMPOWER

Online Resources and Referrals

PLACEBO COMPARATOR

Online Resources and Referrals (ORR) is an information sheet containing materials about the nature of child anxiety and a list of national resources related anxiety treatment. ORR does not include any psychoeducational components regarding parental accommodation.

Behavioral: Project EMPOWER

Interventions

Project EMPOWER BEHAVIORAL

Experimental Condition

Online Resources and Referrals; Project EMPOWER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have at least one child between the ages of 4-10 years old
• Spouse/partner has not taken part of this study before
• Report clinical levels of child anxiety symptoms, per a score above a 7.5 on the Brief SPENCE Children's Anxiety Scale
• Report economic insecurity, indicated by a score less than or equal to 44 on the Consumer Financial Protection Bureau Financial Well-Being Scale (CFPB)

You may not qualify if:

• Participant is non-English speaking

Sponsors & Collaborators

• Stony Brook University: lead
• Robert Wood Johnson Foundation: collaborator

Central Study Contacts

JENNA SUNG, MA

CONTACT

631-632-7800; Jenna.sung@stonybrook.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08