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Parental Guidance for Failure to Launch. (SPACE-FTL)

Primary Purpose

Failure to Launch, Anxiety Disorders, Hikikomori

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPACE parental-guidance
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failure to Launch focused on measuring Parents, Child

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Yale University Child Study CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group (active)

Wait-list control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in FTL status
Change in the adult child's status of accommodation, employment, and participation in academic programs. The status will be measured with the Failure to launch parent screening survey (FTL-SPS). FTL parent screening survey (FTL-PSS). The set of 16 screening questions builds on previous work (Hicks, 2017; Huttner, 2019; Koyama et al., 2010; Nonaka, Shimada, & Sakai, 2018; Teo et al., 2015). The questions are answered by parents/caretakers and focus on objective demographic measures of failure to launch. Parents endorse FTL-PSS items that describe their child's present FTL status.
Change in FTL symptoms
Change in the adult child's status of accommodation, employment, and participation in academic programs. Symptoms will be measured with the adaptive behavior scale for Hikikomori (ABS-H). The Adaptive Behaviors Scale for Hikikomori (ABS-H; Nonaka et al., 2018), is a 38-item scale that measures adaptive behaviors in individuals with FTL. The scale is completed by parents. Parents answer the prevalence of symptoms on a 4 point scale (never, occasionally, often, always). A high average score indicates more FTL symptoms.
Change in clinical severity
We will assess clinical severity and change in severity with the Clinical Global Impression Scale Improvement and Severity (CGI-S, CGI-I). Clinical Global Impression Scale - Severity (CGI-S) and Improvement (CGI-I) (NIMH, 1985). The 14-item scales will be used to assess overall severity (CGI-S) and improvement (CGI-I) at follow up visits. CGI-I scores of 1 ("very much improved") or 2 ("much improved") indicate a positive treatment response; all other responses are considered negative responses.

Secondary Outcome Measures

Change in family accommodation
We will measure parental accommodation with the Family Accommodation Scale - Parent Version (FASA-P) Family Accommodation Scale (FASA-P) (Lebowitz et al., 2013) is a self-report questionnaire used to measure accommodation of or involvement by the family in a child's anxiety symptoms. The FASA contains 9 items that rate the frequency of accommodation, the participation of parents in anxiety symptoms and changes that parents make in routines and schedules due to child's anxiety. Together these items generate the total accommodation score. One additional item assesses the degree of distress the accommodation causes the parents, and four additional items assess short-term, negative consequences of not accommodating.
Change in cost of illness
We will examine changes in cost of FTL (for the individual's parents) with the Failure to Launch Cost of Illness (FTL-COI) measure. Cost-of-illness assessment (FTL-COI) is an in-house 14-item questionnaire that estimates the overall cost of the parent due to supporting their child. Items are summed to produce a total cost of illness per month.

Full Information

First Posted
January 8, 2021
Last Updated
February 17, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT04704583
Brief Title
Parental Guidance for Failure to Launch.
Acronym
SPACE-FTL
Official Title
Parental Guidance for Parents of Highly Dependent Adult Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failure to Launch, Anxiety Disorders, Hikikomori
Keywords
Parents, Child

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized wait-list control group design
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group (active)
Arm Type
Experimental
Arm Description
Individuals in this group will start treatment after the initial assessment, without a delay.
Arm Title
Wait-list control group
Arm Type
Active Comparator
Arm Description
Individuals in this group will start treatment after the initial assessment, with a delay of thirteen weeks.
Intervention Type
Behavioral
Intervention Name(s)
SPACE parental-guidance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in FTL status
Description
Change in the adult child's status of accommodation, employment, and participation in academic programs. The status will be measured with the Failure to launch parent screening survey (FTL-SPS). FTL parent screening survey (FTL-PSS). The set of 16 screening questions builds on previous work (Hicks, 2017; Huttner, 2019; Koyama et al., 2010; Nonaka, Shimada, & Sakai, 2018; Teo et al., 2015). The questions are answered by parents/caretakers and focus on objective demographic measures of failure to launch. Parents endorse FTL-PSS items that describe their child's present FTL status.
Time Frame
Once before and once after the 13 weeks of therapy
Title
Change in FTL symptoms
Description
Change in the adult child's status of accommodation, employment, and participation in academic programs. Symptoms will be measured with the adaptive behavior scale for Hikikomori (ABS-H). The Adaptive Behaviors Scale for Hikikomori (ABS-H; Nonaka et al., 2018), is a 38-item scale that measures adaptive behaviors in individuals with FTL. The scale is completed by parents. Parents answer the prevalence of symptoms on a 4 point scale (never, occasionally, often, always). A high average score indicates more FTL symptoms.
Time Frame
Once before and once after the 13 weeks of therapy
Title
Change in clinical severity
Description
We will assess clinical severity and change in severity with the Clinical Global Impression Scale Improvement and Severity (CGI-S, CGI-I). Clinical Global Impression Scale - Severity (CGI-S) and Improvement (CGI-I) (NIMH, 1985). The 14-item scales will be used to assess overall severity (CGI-S) and improvement (CGI-I) at follow up visits. CGI-I scores of 1 ("very much improved") or 2 ("much improved") indicate a positive treatment response; all other responses are considered negative responses.
Time Frame
Once before and once after the 13 weeks of therapy
Secondary Outcome Measure Information:
Title
Change in family accommodation
Description
We will measure parental accommodation with the Family Accommodation Scale - Parent Version (FASA-P) Family Accommodation Scale (FASA-P) (Lebowitz et al., 2013) is a self-report questionnaire used to measure accommodation of or involvement by the family in a child's anxiety symptoms. The FASA contains 9 items that rate the frequency of accommodation, the participation of parents in anxiety symptoms and changes that parents make in routines and schedules due to child's anxiety. Together these items generate the total accommodation score. One additional item assesses the degree of distress the accommodation causes the parents, and four additional items assess short-term, negative consequences of not accommodating.
Time Frame
Once before and once after the 13 weeks of therapy
Title
Change in cost of illness
Description
We will examine changes in cost of FTL (for the individual's parents) with the Failure to Launch Cost of Illness (FTL-COI) measure. Cost-of-illness assessment (FTL-COI) is an in-house 14-item questionnaire that estimates the overall cost of the parent due to supporting their child. Items are summed to produce a total cost of illness per month.
Time Frame
Once before and once after the 13 weeks of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals with FTL will be characterized as: Living at parents' home. Not employed gainfully for more than 10 hours per week 3. Not actively engaged in educational programs. These conditions have been met for at least six months. Participating Parents will: Consent to the study and all study procedures. Be proficient or fluent in English. Be living with the supported individual. Participants will be excluded based on the following conditions: 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. the individual with FTL is suffering (or likely is suffering) from Substance Use Disorder (including behavioral addictions). the individual with FTL has suffered a major injury or disease and thus cannot work or study. The individual with FTL shows signs of acute suicidality, requiring higher level of care Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eli R Lebowitz, Ph.D.
Phone
2037857905
Email
eli.lebowitz@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Uri Berger, Ph.D.
Phone
2032982177
Email
uri.berger@yale.edu
Facility Information:
Facility Name
Yale University Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eli R Lebowitz, Ph.D.
Phone
203-785-7905
Email
eli.lebowitz@yale.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual participant data for primary and secondary measures will be made available
IPD Sharing Time Frame
Data will be available six months after study completion
IPD Sharing Access Criteria
Data access requests will be reviewed by review panel and requestors will sign a Data Access Agreement
Citations:
PubMed Identifier
30589579
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
22428713
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.
Results Reference
background
PubMed Identifier
22965863
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.
Results Reference
background
PubMed Identifier
25261837
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.
Results Reference
background

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Parental Guidance for Failure to Launch.

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