Clinical Trial: Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE)

Brief Summary: Childhood anxiety disorders are very common, carry tremendous personal and societal costs, frequently do not respond adequately to treatment, and involving parents in treatment has so far not enhanced outcomes. Explanatory clinical trials are needed to identify parent specific mechanisms of change that are not targeted in direct child treatment, and to identify markers of who is most likely to benefit from parent intervention. This study is an explanatory clinical trial of a parent based intervention and of cognitive behavioral therapy, and an investigation of biological and behavioral moderators of treatment response.

Detailed Summary:

Despite strong evidence for the efficacy of individual cognitive-behavior therapy (ICBT) for childhood anxiety disorders, up to 50% of children remain symptomatic after treatment and many still meet diagnostic criteria. Evidence for parental influences in the etiology and maintenance of anxiety in children has often led to the reasonable assumption that adding parent work to ICBT would enhance treatment effects. This idea has now been repeatedly tested in randomized controlled trials (RCTs) that compared ICBT to ICBT with added parent work. The specific content of the parent work has varied but has mainly included teaching parents skills for contingency management, modeling appropriate behavior, and reducing family conflict. Working with parents in these ways has so far not led to enhanced treatment effects compared to ICBT alone, as a number of meta-analytic and comprehensive reviews have shown.

One plausible conclusion from these data is that parent work cannot enhance effects beyond what is achieved through ICBT alone. This study focuses on an alternative plausible conclusion: That parent interventions need to be informed by theoretical working models of parent-specific mechanisms of change that are not targeted in ICBT; and that parent interventions need to be evaluated in explanatory RCTs that ask not only 'does treatment work?' but also 'how and for whom does treatment work?' Underlying systems that shape how parents respond to child anxiety or distress can provide clues to parent-specific targets for intervention and can point to potential moderators of treatment response. Identifying mechanisms by which parent interventions can enhance child anxiety outcomes, and identifying markers of parents most in need of such interventions advances the goal of personalized psychotherapy, and is the overall goal of this study.


Sponsor: Yale University

Current Primary Outcome:

  • Clinical Global Impression Scale Improvement and Severity [ Time Frame: After 12 weeks of treatment ]
    Clinician determined rating of illness
  • Pediatric Anxiety Rating Scale [ Time Frame: After 12 weeks of treatment ]
    Clinician administered rating of child anxiety


Original Primary Outcome: Multidimensional Anxiety Scale for Children (Parent and Child Versions) [ Time Frame: After 12 weeks of treatment ]

A self and parent report of child anxiety


Current Secondary Outcome: Multidimensional Anxiety Scale for Children (Parent and Child Versions) [ Time Frame: After 12 weeks of treatment ]

A self and parent report of child anxiety


Original Secondary Outcome:

Information By: Yale University

Dates:
Date Received: December 3, 2014
Date Started: November 2014
Date Completion: November 2019
Last Updated: June 21, 2016
Last Verified: June 2016