Empowering Anxious Parents to Manage Child Avoidance Behaviors

Anxiety Disorders Clinical Trial

— EMPOWER  

Official title:

Empowering Anxious Parents to Manage Child Avoidance Behaviors: A Randomized Trial of a Single-Session Intervention Targeting Parent Accommodation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04453865
• Other study ID #: IRB2020-00069
• Status: Completed
• Phase: N/A
• Start date: July 5, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: March 2021
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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: a parenting behavior identified as a strong risk factor for anxiety in offspring. Study aims will be three-fold: (1) to examine the SSI's direct effects on parental accommodation, relative to an information-only control; (2) to assess the SSI's immediate effects on parents' perceived ability to help their children manage distressing situations; and (3) to evaluate the SSI's feasibility and acceptability. We will recruit parents reporting elevated anxiety levels, as children of anxious parents are at particular risk for developing anxiety symptoms themselves. Results may suggest a promising approach to preventing anxiety in at-risk children.

Description:

Anxiety disorders are among the most common, debilitating forms of childhood psychopathology, affecting 8.3-27.0% of youth before the age of 18. Child anxiety increases risk for psychiatric comorbidities across the lifespan) creates significant burdens for caregivers, and carries societal costs. Although numerous interventions have been developed to treat youth anxiety disorders, up to 82.2% of US youth with anxiety will not receive adequate care. Several reasons may explain this discrepancy, including the length and cost of existing evidence-based interventions (EBIs) and limited accessibility for families in need.

Single-session interventions (SSIs) may offer one potential solution to this gap in care. SSIs include core components of comprehensive EBIs delivered succinctly to improve the odds of access and completion. In a recent meta-analysis of 50 RCTs, SSIs reduced youth mental health problems of multiple disorders, with SSIs targeting child anxiety producing the largest effects (mean g = 0.58). Thus, well-targeted SSIs may offer cost-effective additions or alternatives to traditional care for anxiety in youth. However, most existing SSIs for child anxiety target populations already experiencing clinical distress, and a need remains for options that may prevent anxiety in vulnerable children. Given that family factors play a crucial role in the etiology of child anxiety, SSIs targeting parents and their interactions with offspring offer a novel approach to preventing youth anxiety. Thus, the aim of this project is to test the acceptability and short-term effects of a novel, web-based SSI targeting parental accommodation: a well-established, potentially modifiable risk factor for child anxiety. Results may reveal a promising, targeted approach to scalable child anxiety prevention.

Parental Accommodation as a Modifiable Intervention Target. Parent accommodation refers to changes in caregiver behaviors that facilitate or maintain their child's avoidance or anxiety. Examples include modifying family routines (i.e., staying home from work to alleviate a child's fear of separating) or directly participating in a child's avoidance strategies (i.e., keeping a child home from school). Parent accommodation reduces immediate distress but maintains long-term avoidance of feared stimuli or situations and high levels of parent accommodation are associated with anxiety problems in offspring. Parent accommodation is further maintained by caregiver factors, including parental anxiety and tolerance for distress. For instance, accommodation is greater among parents reporting higher distress about their child's anxiety symptoms and perceptions that anxiety exposure is harmful for youth.

Research shows that parent accommodation can be systematically reduced via psychosocial intervention, and interventions targeting accommodation have helped mitigate child anxiety. Translating core components of existing interventions that target parental accommodation into briefer, self-administered SSIs (i.e., those that do not involve a trained therapist) may improve families' access to empirically-driven supports for child anxiety. It may also enhance the implementation of mental health interventions by lay providers who frequently interact with children (e.g. teachers and pediatricians). Thus, the goal of this project is to test a web-based, self-guided SSI targeting parental accommodation. Parent participants will be randomized to either (a) Online Resources and Referrals (ORR) + parent accommodation SSI, or (b) ORR alone and delayed SSI access. We predict that parents will report larger declines in accommodation in the ORR+Accommodation SSI group, relative to the ORR + delayed SSI access group, from baseline to 2-week follow-up. We also predict that parents will perceive significant pre-to immediate-post-SSI increases in their ability to help their child manage distressing situations. Finally, we predict that participants will find the SSI to be acceptable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 1, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Report subclinical or greater anxiety symptoms, per a score of 40 or higher on the Penn State Worry Questionnaire (PSWQ)

2. Have at least one child between the ages of 4-10 years old

3. Live in the United States (US)

Exclusion Criteria:

1. Participant is non-English speaking

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Project EMPOWER
Project EMPOWER is a web-based, self-administered SSI for parents that takes about 30 minutes to complete

Other:
• Online Resources and Referrals
Information sheet containing materials about the nature of child anxiety and a list of national resources related anxiety treatment.

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

References & Publications (21)

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Lebowitz ER, Panza KE, Su J, Bloch MH. Family accommodation in obsessive-compulsive disorder. Expert Rev Neurother. 2012 Feb;12(2):229-38. doi: 10.1586/ern.11.200. Review. — View Citation

Lebowitz ER, Scharfstein L, Jones J. Child-Report of Family Accommodation in Pediatric Anxiety Disorders: Comparison and Integration with Mother-Report. Child Psychiatry Hum Dev. 2015 Aug;46(4):501-11. doi: 10.1007/s10578-014-0491-1. — View Citation

Lebowitz, E. R., Omer, H., Hermes, H., & Scahill, L. (2014). Parent Training for Childhood Anxiety Disorders: The SPACE Program. Cognitive and Behavioral Practice, 21(4), 456- 469. https://doi.org/10.1016/j.cbpra.2013.10.004

Merikangas KR, He JP, Burstein M, Swendsen J, Avenevoli S, Case B, Georgiades K, Heaton L, Swanson S, Olfson M. Service utilization for lifetime mental disorders in U.S. adolescents: results of the National Comorbidity Survey-Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):32-45. doi: 10.1016/j.jaac.2010.10.006. Epub 2010 Dec 3. — View Citation

Mojtabai R, Olfson M, Sampson NA, Jin R, Druss B, Wang PS, Wells KB, Pincus HA, Kessler RC. Barriers to mental health treatment: results from the National Comorbidity Survey Replication. Psychol Med. 2011 Aug;41(8):1751-61. doi: 10.1017/S0033291710002291. Epub 2010 Dec 7. — View Citation

Ramos-Cerqueira AT, Torres AR, Torresan RC, Negreiros AP, Vitorino CN. Emotional burden in caregivers of patients with obsessive-compulsive disorder. Depress Anxiety. 2008;25(12):1020-7. doi: 10.1002/da.20431. — View Citation

Salloum A, Johnco C, Lewin AB, McBride NM, Storch EA. Barriers to access and participation in community mental health treatment for anxious children. J Affect Disord. 2016 May 15;196:54-61. doi: 10.1016/j.jad.2016.02.026. Epub 2016 Feb 10. — View Citation

Schleider JL, Dobias ML, Sung JY, Mullarkey MC. Future Directions in Single-Session Youth Mental Health Interventions. J Clin Child Adolesc Psychol. 2020 Mar-Apr;49(2):264-278. doi: 10.1080/15374416.2019.1683852. Epub 2019 Dec 4. — View Citation

Schleider JL, Mullarkey MC, Weisz JR. Virtual Reality and Web-Based Growth Mindset Interventions for Adolescent Depression: Protocol for a Three-Arm Randomized Trial. JMIR Res Protoc. 2019 Jul 9;8(7):e13368. doi: 10.2196/13368. — View 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. Review. — View Citation

Schleider, J. L., & Weisz, J. R. (2017a). Can less be more? The promise (and perils) of single session youth mental health interventions. The Behavior Therapist, 40(7), 256-261.

Settipani CA, Kendall PC. The Effect of Child Distress on Accommodation of Anxiety: Relations With Maternal Beliefs, Empathy, and Anxiety. J Clin Child Adolesc Psychol. 2017 Nov-Dec;46(6):810-823. doi: 10.1080/15374416.2015.1094741. Epub 2015 Dec 16. — View Citation

Storch, E. A., Lehmkuhl, H., Pence, S. L., Geffken, G. R., Ricketts, E., Storch, J. F., & Murphy, T. K. (2009). Parental experiences of having a child with obsessive-compulsive disorder: Associations with clinical characteristics and caregiver adjustment. Journal of Child and Family Studies, 18(3), 249-258.

Thompson-Hollands J, Kerns CE, Pincus DB, Comer JS. Parental accommodation of child anxiety and related symptoms: range, impact, and correlates. J Anxiety Disord. 2014 Dec;28(8):765-73. doi: 10.1016/j.janxdis.2014.09.007. Epub 2014 Sep 16. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Accommodation at 2-week follow up
Primary	Perceived pre-to-post SSI change	This single-item measure assesses participants' perceived change in their ability to help their children manage distressing situations from pre- to post-SSI: "compared to before you completed this program, how prepared do you feel to help your child manage distressing situations?" Parents in both groups will rate this question on a 5-point scale of 1 (much less able to help child manage distressing situations) to 5 (much more able to to help child manage distressing situations).	Immediately after the SSI
Secondary	Program Feedback Scale	The program feedback scale asks participants to rate 7 statements regarding acceptability and feasibility; note whether they would recommend this activity to others; and share what they liked and would change about the SSI. The 7 statements are rated from 0 (Really Disagree) to 5 (Really Agree). Total score ranges from 0 to 35, with higher scores indicating a more positive program evaluation.	Immediately after the SSI
Secondary	Penn State Worry Questionnaire	16 item self-report questionnaire that asks individuals to rate how typical worry-related problems are for them, from 1 (not at all typical) to 5 (very typical). Scores range from 16-80; higher scores indicate more severe worry.	Baseline
Secondary	Coping with Children's Negative Emotions Scale	Coping with Children's Negative Emotions Scale measures parents' reactive emotions to their child's negative affect in distressing situations. Six subscales exist, but only the "distress reactions" domain, reflecting parental distress in the context of child negative affect, will be used. Participants rate 12 questions from 1 (very unlikely) to 7 (very likely). Score ranges from 12-84; higher numbers indicate more distress.	Baseline
Secondary	Revised Children's Anxiety and Depression Scale	25 item measure assessing child's symptoms of anxiety and depression. Each question is rated on a 4-point scale from 0 (Never) to 3 (Always). Total score ranges from 0 to 75 with higher scores indicating higher levels of psychopathology	Baseline
Secondary	Barriers to Access to Care Evaluation	30 item self-report questionnaire that asks about barriers they faced in getting professional care for a mental health problem on a scale of 0 (not at all) to 3 (a lot). Scores range from 0 to 90; higher scores indicate a higher number of barriers.	Baseline
Secondary	Adult Measure of Behavioral Inhibition	16 item measure assessing one's temperamental tendency to respond to social novelty and risk stimuli, with inhibition and avoidance. Each question is rated on a 3 point scale from 0 (no/hardly ever) and 2 (yes/most of the time). Total score ranges from 0 to 32 with a higher scores indicating a greater degree of inhibition.	Baseline
Secondary	Short Behavioral Inhibition Questionnaire	14-item parent rated scale measuring temperamental characteristics referring to shyness, fearfulness, and withdrawal in young, preschool children. Each question is rated on a 7-point scale from 1 (Hardly Ever) to 7 (Almost Always). Total score ranges from 14 to 98, with higher scores indicating a greater degree of inhibition	Baseline
Secondary	Ruminative Response Scale	22 item questionnaire measuring two aspects of rumination: brooding and reflective pondering. Each question is rated on a 4-point scale from 1 (almost never) and 4 (almost always). Total score ranges from 22 to 88 with a higher score indicating higher ruminative tendencies.	Baseline
Secondary	Distress Tolerance Scale	16 item measure assessing the extent to which one experiences and withstand distressing emotional states. Each item is rated on a 5-point Likert scale from 1 (strongly agree) and 5 (strongly disagree). Total score ranges from 16 to 80 with a higher score indicating higher levels of distress tolerance.	Change from Baseline Coping at 2-week follow up
Secondary	Co-Rumination Questionnaire	27-item self-report inventory that measures the extent to which one co-ruminates with others. For brevity, the survey has been modified to consist of 8 items that range from 1 (Not at all true) to 5 (really true). Total score ranges from 8 to 40 with a higher score indicating higher levels of co-rumination.	Baseline
Secondary	Patient Reported Outcomes Measurement Information System-Depression Short	8 item self-report measure of depression. The questions are rated on a 5-point scale ranging from 1 (never) to 5 (always). Scores range from 8 to 40m higher scores indicating higher levels of depression.	Baseline