Psychosis
Conditions
Keywords
prodrome, family therapy, clinical high risk
Brief summary
The purpose of this study is to learn whether a new family therapy using computer games with biofeedback might help people at clinical high risk for psychosis and their family members learn to experience less stress and have fewer mental health challenges.
Detailed description
CALMS revolves around the use of Emotional Manipulatives (EM) developed at Boston Children's Hospital (BCH). EM are single and multi-user biofeedback games designed to enhance executive control of emotion. The intervention and EM in CALMS were adapted from those used in Anger Control Training (ACT) with Regulate and Gain Emotional Control (RAGE-Control). In a randomized controlled trial at BCH, ACT and RAGE-Control relative to sham video-game play without biofeedback led to significantly greater reductions of aggression in adolescents and greater improvement in family functioning. In this feasibility study, family dyads will participate in 12 sessions aimed at 1. enhancing engagement through the use of video and other games, 2. enhancing stress resilience through biofeedback, education, and individualized stress-reduction practice, and 3. harnessing the power of the family to enhance contextual learning and the generality and duration of effects. Clinical, self-report, and heart rate measures will be assessed at baseline, 4, 8, and 12 week assessments.
Interventions
BEHAVIORALCALMS
Family Therapy; Multi-user Biofeedback Videogames
Sponsors
National Institute of Mental Health (NIMH)
Boston Children's Hospital
Beth Israel Deaconess Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Currently Meet or Have Met Criteria of Prodromal Syndromes (COPS) according to the SIPS within the past 2 years * Estimated IQ \> 70 * Speak fluent English * Have at least one parent or adult family member who also speaks fluent English and is willing to participate
Exclusion criteria
* Physical limitations precluding effective use of biofeedback videogames * Co-morbid psychiatric disorders, including substance disorders, but only if they better explain COPS symptoms or make participation counter-indicated. * Active suicidal ideation or attempts within the past 2 months unless being actively monitored and treated for this by a clinician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Percent of referred who consent and meet study criteria | Up to six months | Enrollment |
| Feasibility: Percent of 12 sessions completed | Up to six months | Engagement: Percent of sessions completed by consented and eligible participants |
| Feasibility: Counts of premature termination of intervention | Up to six months | — |
| Feasibility: Self-report of Credibility/Satisfaction | 12 week assessment or last assessment completed | Individual and family member self-report |
| Feasibility: Self-report of User Experience | 12 week assessment or last assessment completed | Self-report of ability to learn/use technology to lower stress reactivity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Global Functioning relative to Baseline | Weeks 4, 8, and 12 Assessments | SIPS Global Assessment of Functioning |
| Safety: Change in Hostility/Aggression relative to Baseline | Weeks 4, 8, and 12 | Self-report |
| Change in Social and Role Functioning relative to Baseline | Weeks 4, 8, and 12 Assessments | Global Functioning: Social & Role Scales; |
| Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task | Baseline, Weeks 4,8, and 12 | Executive Control of Emotion |
| Safety: Change in Video-game Addiction relative to Baseline | Weeks 4, 8, and 12 | Self-report |
| Positive Symptom Score Change relative to Baseline | Weeks 4,8, and 12 Assessments | Total positive symptom score according to the Structured Interview of Psychosis-risk Syndromes (SIPS) |
| Change in Perceived Stress relative to Baseline | Weeks 4, 8, and 12 Assessments | Self-report via Perceived Stress Scale |
| Change relative to Baseline in Youth Perceptions of Relationship with Family Member | Weeks 4, 8, 12 Assessments | Self-report of conflict, criticism, and warmth in relationship with participating family member |
| Change relative to Baseline in Parent Perceptions of Relationship with Adolescent or Young Adult | Weeks 4, 8, 12 Assessments | Self-report of conflict, criticism, and warmth in relationship with youth |
Countries
United States
Outcome results
None listed