Feasibility Trial of a Parent Peer-Co-Led Caregiver Group for Pediatric Early Onset Schizophrenia Spectrum Disorders

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Children's Hospital

About this trial

While early onset schizophrenia spectrum disorders are among the most debilitating psychiatric illnesses, evidence-based treatment for this population is limited. This study evaluates the feasibility and acceptability of a parent peer co-led group intervention for caregivers of youth with Early Onset Schizophrenia Spectrum Disorder to support further refinement.

Caregivers of youth with Early Onset Schizophrenia Spectrum Disorder will be invited to participate. Participants will be assigned to either the treatment group or the wait-list control group. Those in the treatment group will receive the group intervention immediately at study start and wait-list participants will be invited to participate following completion of the study. The group intervention consists of 10 group therapy intervention sessions covering psychosis psychoeducation (e.g. symptoms monitoring, stress \& stress management, family communication skills, and coping skills).

Feasibility will be assessed through recruitment and retention, acceptability through the Client Satisfaction Questionnaire. Secondary aims include effectiveness using Goal Attainment Scaling (GAS), Perceived Stress Scale (PSS), and qualitative feedback from participants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals who are 18 years old or older.

Individuals who are primary caregivers

Individuals are caregivers of a young person who meets criteria for EOSSD per clinician report.

Individuals who are fluent in English.

Disqualifiers

Non-fluency in English.

Impaired decision making capacity per PI review.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group Therapy

    Behavioral

    The intervention consists of 10 sessions. Intervention sessions are held over a secure zoom platform, for 1-1.5 hrs, with up to 10 participants, once/week. The group will be facilitated by licensed psychologist. The group sessions will include, 1) Introductions, Goal Setting, Group Norms, Overview of Group, 2) Psychosis Psychoeducation, 3) Developmental Considerations, 4) Mental Health Systems \& Collaborating with Schools, 5) Role of Stress and Decreasing Stress in the Home, 6) Communication Skills, 7) Health Behaviors, 8) Coping Skills \& The Science of Psychosis, 9) Medications \& Prevention Planning, 10) Goal Setting \& Wrap-Up.

  • Treatment as Usual (TAU)

    Other intervention

    Participants in the Waitlist group will receive treatment as usual (parent support and guidance from child's clinician, individual therapy for child, and psychopharmacological medication management for their child).

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Treatment GroupExperimental treatment 1 intervention
Group B: Wait List Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility measured as attendance to the group sessions

The average number of total group sessions attended

Time frame
Immediately following the last intervention session
2

Acceptability as measured on the Client Satisfaction Questionnaire-Participant Versions (CSQ)

Client Satisfaction Questionnaire-Participant (CSQ) - used to assess acceptability of intervention, as defined by participant ratings on quality of service, fits of the intervention to meet need to support satisfaction, and overall satisfaction.

Time frame
Within two weeks following group intervention completion

Secondary outcomes

1

Effectiveness of the intervention as measured on progress on the Goal Attainment Scale (GAS)

Effectiveness is defined as progress made towards individualized patient's goals, we will assess the difference in progress made towards goals between those in the wait-list control and treatment group. Progress towards caregiver goals will be measured using Goal Attainment Scale (GAS).

Time frame
Within two weeks following group intervention completion
2

Social Validity

Social validity as assessed via the Semi-structured Interview for Social Validation

Time frame
Post-Intervention

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: