Parental Guidance for Failure to Launch.

NCT ID: NCT04704583

Last Updated: 2024-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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%.

Conditions

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Failure to Launch Anxiety Disorders Hikikomori

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized wait-list control group design
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment group (active)

Individuals in this group will start treatment after the initial assessment, without a delay.

Group Type EXPERIMENTAL

SPACE parental-guidance

Intervention Type BEHAVIORAL

The treatment will be delivered to the parents in ten 50-minute sessions. The sessions are planned to be weekly and will be completed within 13 weeks of the first session. The sessions include instruction and education, acquiring skills, role-play, and simulations. Parents will be given exercises and goals in reducing accommodation to achieve at home (in cognitive behavioral therapy this is sometimes called 'homework') in some of the sessions. For example, parents to write down one or two things that they would most like to see their child handling better.

Wait-list control group

Individuals in this group will start treatment after the initial assessment, with a delay of thirteen weeks.

Group Type ACTIVE_COMPARATOR

SPACE parental-guidance

Intervention Type BEHAVIORAL

The treatment will be delivered to the parents in ten 50-minute sessions. The sessions are planned to be weekly and will be completed within 13 weeks of the first session. The sessions include instruction and education, acquiring skills, role-play, and simulations. Parents will be given exercises and goals in reducing accommodation to achieve at home (in cognitive behavioral therapy this is sometimes called 'homework') in some of the sessions. For example, parents to write down one or two things that they would most like to see their child handling better.

Interventions

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SPACE parental-guidance

The treatment will be delivered to the parents in ten 50-minute sessions. The sessions are planned to be weekly and will be completed within 13 weeks of the first session. The sessions include instruction and education, acquiring skills, role-play, and simulations. Parents will be given exercises and goals in reducing accommodation to achieve at home (in cognitive behavioral therapy this is sometimes called 'homework') in some of the sessions. For example, parents to write down one or two things that they would most like to see their child handling better.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yale University Child Study Center

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30589579 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 22428713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22965863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25261837 (View on PubMed)

Other Identifiers

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No NIH funding

Identifier Type: OTHER

Identifier Source: secondary_id

2000029082

Identifier Type: -

Identifier Source: org_study_id

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