Clinical trial NCT04704583: Parental Guidance for Failure to Launch.
Official title: Parental Guidance for Parents of Highly Dependent Adult Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failure to Launch
Anxiety Disorders
Hikikomori
Keywords: Parents
Child
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized wait-list control group design
Primary purpose: TREATMENT

Brief summary: In the proposed study the outcome of administering parental guidance, based on the Supportive Parenting for Anxious Childhood Emotions (SPACE) program, to parents of highly dependent adult children will be explored. The proposed study's primary purpose is to assess the outcome of parental guidance. In addition, the study will also examine participants' acceptance and adherence to this parental guidance method.

Detailed description: Recent years have seen an increase in the number of adult Americans who live with their parents. In the 18 to 34 age group, living with one's parents is currently the most common living arrangement. Some adult children have been using their parents' homes as only a temporary solution due to economic hardship. However, other adults remain at home, highly reliant on their parents, and not in higher education or employment. The latter group (who are at times referred to as 'failure to launch') are considered to suffer from a combination of a personal and familial problem and pose a significant challenge for therapists (Lebowitz, 2016). To date, little evidence exists to guide case conceptualization or intervention strategies. In this protocol, the term "FTL" for the sake of brevity in place of "highly dependent adult children who are not functioning independently" will be used.

For the clinician, work with individuals with FTL cases can seem more like treatment with child patients than adult patients. Parents often initiate clinical contact, and in many cases, the dependent adult is not open or willing to engage in treatment directly.

Dr. Lebowitz and colleagues' work with the parents of youth who suffer from clinical anxiety has suggested a theoretical conceptualization and a means of intervention in cases of FTL. Youth with anxiety display a similar pattern of reliance on parents for help in avoiding the situations they find distressing, a process known as family accommodation. Working with parents on decreasing family accommodation has been found to be efficacious in reducing anxiety and increasing independent coping in youth. This manualized approach, known as SPACE (Supportive Parenting for Anxious Childhood Emotions), has been repeatedly tested in clinical trials, including in randomized controlled trial research.

In the proposed study, the investigators will examine outcomes of a parental guidance program, based on SPACE, for parents of FTL adults (henceforth, SPACE-FTL). The current proposal builds on a published feasibility study that found reducing family accommodation was successful in FTL, and in a considerable proportion of cases the adult children started working or studying or moved to independent lodgings.

In the study, the investigators aim to investigate the SPACE-FTL outcomes including improvement in adult child symptoms and reductions in related impairment (e.g., cost-of-illness), when compared to no treatment (i.e., wait-list control). The primary hypothesis is that SPACE-FTL will decrease FTL severity and impairment, compared with the wait-list control condition. Additional outcomes will relate to the feasibility, acceptability, and parents' satisfaction of SPACE-FTL. The investigators hypothesize that parents will rate SPACE-FTL as highly acceptable and that adherence will be above 70%.

Eligibility criteria: Inclusion Criteria:

Individuals with FTL will be characterized as:

1. Living at parents' home.
2. Not employed gainfully for more than 10 hours per week 3. Not actively engaged in educational programs.
3. These conditions have been met for at least six months.

Participating Parents will:

1. Consent to the study and all study procedures.
2. Be proficient or fluent in English.
3. Be living with the supported individual.

Participants will be excluded based on the following conditions:

1. The individual with FTL is suffering (or likely is suffering) from a major mental disorder, per parent report. This includes any lifetime history of a psychotic disorder, bipolar disorder, Autism spectrum disorder, or intellectual delay.
2. the individual with FTL is suffering (or likely is suffering) from Substance Use Disorder (including behavioral addictions).
3. the individual with FTL has suffered a major injury or disease and thus cannot work or study.
4. The individual with FTL shows signs of acute suicidality, requiring higher level of care

Exclusion Criteria:

-

Primary outcomes:
measure: Change in FTL status
timeFrame: Once before and once after the 13 weeks of therapy
measure: Change in FTL symptoms
timeFrame: Once before and once after the 13 weeks of therapy
measure: Change in clinical severity
timeFrame: Once before and once after the 13 weeks of therapy
Secondary outcomes:
measure: Change in family accommodation
timeFrame: Once before and once after the 13 weeks of therapy
measure: Change in cost of illness
timeFrame: Once before and once after the 13 weeks of therapy
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University Child Study Center
state: Connecticut
Study officials:
References:
citation: Lebowitz ER, Shimshoni Y. The SPACE program, a parent-based treatment for childhood and adolescent OCD: The case of Jasmine. Bull Menninger Clin. 2018 Fall;82(4):266-287. doi: 10.1521/bumc.2018.82.4.266.
citation: Fry, R. (2016). For First Time in Modern Era, Living with Parents Edges out Other Living Arrangements for 18-to 34-Year-Olds: Share Living with Spouse or Partner Continues to Fall. Pew Research Center.
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.
citation: Lebowitz E, Dolberger D, Nortov E, Omer H. Parent training in nonviolent resistance for adult entitled dependence. Fam Process. 2012 Mar;51(1):90-106. doi: 10.1111/j.1545-5300.2012.01382.x.
citation: Lebowitz ER, Woolston J, Bar-Haim Y, Calvocoressi L, Dauser C, Warnick E, Scahill L, Chakir AR, Shechner T, Hermes H, Vitulano LA, King RA, Leckman JF. Family accommodation in pediatric anxiety disorders. Depress Anxiety. 2013 Jan;30(1):47-54. doi: 10.1002/da.21998. Epub 2012 Sep 10.
citation: 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.