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

Anxiety Disorders Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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.

Family accommodation (FA) describes parents' attempts to help a child avoid feeling anxious by participating in symptom-driven behaviors and modifying family routines. FA is highly prevalent among parents of anxious children and has been linked to greater symptom severity in the child and to poorer response to ICBT. Research has linked a number of biological and behavioral parent markers to protective parental behavior and to child anxiety. The nonapeptide oxytocin (OT) is implicated in parental attachment and protective behavior in humans and animals. Coded behavioral observations link aspects of parental behavior (i.e., autonomy granting, over involvement, and sensitivity) to child anxiety. A number of studies also have shown that these biological and behavioral markers interact to predict anxiety outcomes in at-risk children. Yet so far this research has been siloed from intervention research and has not informed parent-based treatments, highlighting the need for clinical investigators equipped with the necessary skills to integrate multiple units of analysis into explanatory RCTs of novel interventions.

This study represents a fusion of clinical, biological and behavioral research through an explanatory RCT of a parent-based treatment focused on modifying parental responses to child anxiety and distress as a mediator of treatment outcome, and on biological and behavioral markers as possible moderators of treatment outcome. The intervention evaluated in this study (Supportive Parenting for Anxious Childhood Emotions; SPACE) aims to systematically reduce FA through a series of concrete manualized steps. This study is an integrated explanatory RCT of SPACE with the following 3 specific aims:

Aim 1 - Specificity: Does SPACE lead to significantly lower levels of FA compared to ICBT? Hypothesis: Levels of FA for parents in SPACE will be significantly lower after treatment than before treatment, as compared to parents of children in ICBT.

Aim 2 - Mediation: Does reducing FA lead to positive child outcomes? Hypothesis: Parents' reduced FA will be a significant mediator of positive child outcomes (i.e., reduced child anxiety).

Aim 3 - Moderation: Do key biological and behavioral markers (i.e., parental OT, autonomy granting, over involvement, sensitivity) moderate child outcomes? Hypothesis: Baseline levels of maternal OT, autonomy granting, over involvement, and sensitivity will be significant moderators of child outcomes (i.e., reducing child anxiety). ;

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Disease
• Phobic Disorders

• NCT number: NCT02310152
• Study type: Interventional
• Source: Yale University
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Completion date: November 2018