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Youth Early-intervention Study (YES) - group interventions targeting social participation and physical well-being as an adjunct to treatment as usual: study protocol for a randomized controlled trial.

Gehue LJ, Scott E, Hermens DF, Scott J, Hickie I - Trials (2015)

Bottom Line: However, few interventions for youth presenting to mental health services offer a coherent rationale for multi-faceted approaches that efficiently address all these targets.Randomization determines whether individuals commence with module A or module B.The sample will be assessed pre-randomization, and at week 1 and week 8 (after completion of the first module), and at week 11 (commencement of second module) and week 19 (completion of second module).

View Article: PubMed Central - PubMed

Affiliation: Clinical Research Unit, Brain and Mind Research Institute, The University of Sydney, Sydney, NSW, Australia. gehue@icloud.com.

ABSTRACT

Background: It is increasingly acknowledged that clinical interventions for young persons with mental disorders need to optimize social, vocational and physical functioning, and take into account developmental needs, rather than focusing only on the traditional target of psychiatric symptom change. However, few interventions for youth presenting to mental health services offer a coherent rationale for multi-faceted approaches that efficiently address all these targets. This trial uses two facilitated group therapy modules (social and physical activity) as a vehicle for promoting clinical, cognitive, social and vocational change. The modules are an adjunct to usual treatments offered to youth attending mental health services in Sydney, Australia.

Methods/design: The design is a 2-arm, parallel group cross-over, randomized clinical trial (RCT) that examines the efficacy of this adjunctive youth early intervention program (called "YES") for improving social, vocational, mental and physical health functioning in a trans-diagnostic sample of 120 young persons aged 14-25 years who are currently receiving a range of "usual treatments" for clinically diagnosed anxiety, affective and/or psychotic disorders. Individuals who provide written informed consent are offered 2 group therapy modules (each comprising 4 hours per week for 8 weeks) with a 3-week "pause" between modules. Randomization determines whether individuals commence with module A or module B. The sample will be assessed pre-randomization, and at week 1 and week 8 (after completion of the first module), and at week 11 (commencement of second module) and week 19 (completion of second module). Final follow-up is 1-year post trial entry.

Discussion: If the findings of this exploratory trial demonstrate benefits in the target domains, then it will be important to extend the research by undertaking: (a) a comparison of the YES program to a control intervention in a randomized controlled trial, (b) an explanatory study of putative mediators of change, and (c) a multi-center trial with a number of trained therapists offering the group modules combined with a longer follow-up period.

Trial registration: Australian New Zealand Controlled Trial Registration: ACTRN1262400175673 , Date: 16 July 2015.

No MeSH data available.


Related in: MedlinePlus

Recruitment, consent and randomization flowchart
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Related In: Results  -  Collection

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Fig1: Recruitment, consent and randomization flowchart

Mentions: Individuals who are eligible for the study will be randomized to start with either: module A (Social Participation) followed by module B (Physical Well-being) or to start with module B followed by module A. An independent person (i.e. a colleague not directly involved with the study) will undertake the randomization using a computerized random number generator program Fig. 1.Fig. 1


Youth Early-intervention Study (YES) - group interventions targeting social participation and physical well-being as an adjunct to treatment as usual: study protocol for a randomized controlled trial.

Gehue LJ, Scott E, Hermens DF, Scott J, Hickie I - Trials (2015)

Recruitment, consent and randomization flowchart
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4525721&req=5

Fig1: Recruitment, consent and randomization flowchart
Mentions: Individuals who are eligible for the study will be randomized to start with either: module A (Social Participation) followed by module B (Physical Well-being) or to start with module B followed by module A. An independent person (i.e. a colleague not directly involved with the study) will undertake the randomization using a computerized random number generator program Fig. 1.Fig. 1

Bottom Line: However, few interventions for youth presenting to mental health services offer a coherent rationale for multi-faceted approaches that efficiently address all these targets.Randomization determines whether individuals commence with module A or module B.The sample will be assessed pre-randomization, and at week 1 and week 8 (after completion of the first module), and at week 11 (commencement of second module) and week 19 (completion of second module).

View Article: PubMed Central - PubMed

Affiliation: Clinical Research Unit, Brain and Mind Research Institute, The University of Sydney, Sydney, NSW, Australia. gehue@icloud.com.

ABSTRACT

Background: It is increasingly acknowledged that clinical interventions for young persons with mental disorders need to optimize social, vocational and physical functioning, and take into account developmental needs, rather than focusing only on the traditional target of psychiatric symptom change. However, few interventions for youth presenting to mental health services offer a coherent rationale for multi-faceted approaches that efficiently address all these targets. This trial uses two facilitated group therapy modules (social and physical activity) as a vehicle for promoting clinical, cognitive, social and vocational change. The modules are an adjunct to usual treatments offered to youth attending mental health services in Sydney, Australia.

Methods/design: The design is a 2-arm, parallel group cross-over, randomized clinical trial (RCT) that examines the efficacy of this adjunctive youth early intervention program (called "YES") for improving social, vocational, mental and physical health functioning in a trans-diagnostic sample of 120 young persons aged 14-25 years who are currently receiving a range of "usual treatments" for clinically diagnosed anxiety, affective and/or psychotic disorders. Individuals who provide written informed consent are offered 2 group therapy modules (each comprising 4 hours per week for 8 weeks) with a 3-week "pause" between modules. Randomization determines whether individuals commence with module A or module B. The sample will be assessed pre-randomization, and at week 1 and week 8 (after completion of the first module), and at week 11 (commencement of second module) and week 19 (completion of second module). Final follow-up is 1-year post trial entry.

Discussion: If the findings of this exploratory trial demonstrate benefits in the target domains, then it will be important to extend the research by undertaking: (a) a comparison of the YES program to a control intervention in a randomized controlled trial, (b) an explanatory study of putative mediators of change, and (c) a multi-center trial with a number of trained therapists offering the group modules combined with a longer follow-up period.

Trial registration: Australian New Zealand Controlled Trial Registration: ACTRN1262400175673 , Date: 16 July 2015.

No MeSH data available.


Related in: MedlinePlus