Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarelon Research

About this trial

This is a two-arm, prospective, longitudinal, randomized controlled trial (RCT) that will compare usual care to usual care plus a prenatally initiated, virtually administered psychological intervention, called HeartGPS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.

Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.

CHD diagnosis received between 16.0 and 30.0 weeks gestation.

Singleton pregnancy.

Disqualifiers

Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.

Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial.

Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.

Postnatal diagnosis of CHD.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HeartGPS

    Other intervention

    GPS stands for Guiding parents through emotions, Providing information and support, and Strengthening connections. Participants randomized to the treatment group will participate in HeartGPS, which includes three key components tailored to the CHD population: 1. Eight virtually administered counseling sessions, 2. Tailored educational resource, 3. Mental health care plan.

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Usual Fetal Cardiac CareNo intervention 0 interventions
Group B: HeartGPSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety.

State-Trait Anxiety Inventory (STAI) - State total score at 4 months

Time frame
4 months

Secondary outcomes

1

STAI-State total score at 36 weeks gestation

State-Trait Anxiety Inventory (STAI) - State total score at 36 weeks gestation. Range is 20-80, with higher scores indicating higher levels of anxiety.

Time frame
36 weeks gestation
2

STAI-State total score at 1-2 months postpartum

State-Trait Anxiety Inventory (STAI)-State total score at 1-2 months postpartum. Range is 20-80, with higher scores indicating higher levels of anxiety.

Time frame
1-2 months postpartum
3

STAI-State total score at 12 months postpartum

State-Trait Anxiety Inventory (STAI)-State total score at 12 months postpartum. Range is 20-80, with higher scores indicating higher levels of anxiety.

Time frame
12 months postpartum
4

PCL-5 total score at 4 months

PTSD Checklist for DSM-5 (PCL-5) total score at 4 months. Range is 0-80, with higher scores indicating greater symptom severity.

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.