Trial Outcomes & Findings for A Randomized Controlled Trial of PCIT-ED for Preschool Depression (NCT NCT02076425)

NCT ID: NCT02076425

Last Updated: 2019-12-02

Results Overview

The Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (K-SADS-EC) is a semi-structured clinical interview for DSM-5 disorders adapted for use in children aged 3-6. The MDD core symptom score was the number of core MDD symptoms endorsed on the K-SADS-EC. These 9 symptoms were (1) depressed mood, (2) anhedonia, (3) insomnia/hypersomnia, (4) fatigue, (5) decreased concentration, (6) weight/appetite change, (7) psychomotor agitation/retardation, (8) worthlessness/guilt, (9) suicidal thoughts/behaviors. The range of possible values is 0-9, with 9 being the worst outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

229 participants

Primary outcome timeframe

completion of therapy (average of 20 weeks)

Results posted on

2019-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	PCIT-ED Parent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. PCIT-ED	Wait List No intervention while subjects wait for PCIT-ED in the second phase of the study.
Overall Study STARTED	114	115
Overall Study COMPLETED	100	91
Overall Study NOT COMPLETED	14	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized Controlled Trial of PCIT-ED for Preschool Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PCIT-ED n=114 Participants Parent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. PCIT-ED	Wait List n=115 Participants No intervention while subjects wait for PCIT-ED in the second phase of the study.	Total n=229 Participants Total of all reporting groups
Age, Continuous	5.14 years STANDARD_DEVIATION 0.97 • n=5 Participants	5.28 years STANDARD_DEVIATION 1.13 • n=7 Participants	5.21 years STANDARD_DEVIATION 1.05 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	42 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	73 Participants n=7 Participants	149 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=5 Participants	105 Participants n=7 Participants	204 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	18 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants	82 Participants n=7 Participants	176 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	114 Participants n=5 Participants	115 Participants n=7 Participants	229 Participants n=5 Participants
K-SADS-EC MDD Core Symptom Score	5.49 units on a scale STANDARD_DEVIATION 1.47 • n=5 Participants	5.71 units on a scale STANDARD_DEVIATION 1.51 • n=7 Participants	5.60 units on a scale STANDARD_DEVIATION 1.49 • n=5 Participants
Preschool Feelings Checklist-Scale Version (PFC-Scale) Score	38.77 units on a scale STANDARD_DEVIATION 9.57 • n=5 Participants	41.71 units on a scale STANDARD_DEVIATION 11.37 • n=7 Participants	40.25 units on a scale STANDARD_DEVIATION 10.59 • n=5 Participants
Children's Global Assessment Scale (CGAS) Score	44.00 units on a scale (0-100) STANDARD_DEVIATION 6.51 • n=5 Participants	42.61 units on a scale (0-100) STANDARD_DEVIATION 6.57 • n=7 Participants	43.30 units on a scale (0-100) STANDARD_DEVIATION 6.56 • n=5 Participants

PRIMARY outcome

Timeframe: completion of therapy (average of 20 weeks)

Outcome measures

Outcome measures
Measure	PCIT-ED n=100 Participants Parent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. PCIT-ED	Wait List n=91 Participants No intervention while subjects wait for PCIT-ED in the second phase of the study.
Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score	1.74 number of symptoms (0-9) Standard Deviation 1.69	4.15 number of symptoms (0-9) Standard Deviation 2.04

SECONDARY outcome

Timeframe: completion of therapy (average of 20 weeks)

The Preschool Feelings Checklist - Scale Version (PFC-Scale), was adapted from the PFC, which is a validated screening checklist used to capture young children at high risk for MDD. The PFC-Scale is a 23-item Likert scale with possible values of 0, 1, 2, 3, or 4 for each item. The total score is a sum of the 23 items, so the range of possible values is 0-92, with 92 being the most severe score possible.

Outcome measures

Outcome measures
Measure	PCIT-ED n=99 Participants Parent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. PCIT-ED	Wait List n=90 Participants No intervention while subjects wait for PCIT-ED in the second phase of the study.
Preschool Feelings Checklist-Scale Version (PFC-Scale) Score	20.13 units on a scale Standard Deviation 9.68	33.24 units on a scale Standard Deviation 11.12

OTHER_PRE_SPECIFIED outcome

Timeframe: completion of therapy (average of 20 weeks)

The Children's Global Assessment Scale (CGAS) is a standardized instrument that measures children's global level of impairment completed by the clinician-rater. The possible range of values is 0-100, with 0 indicating the most severe global impairment.

Outcome measures

Outcome measures
Measure	PCIT-ED n=100 Participants Parent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. PCIT-ED	Wait List n=91 Participants No intervention while subjects wait for PCIT-ED in the second phase of the study.
Children's Global Assessment Scale (CGAS) Score	76.83 units on a scale (0-100) Standard Deviation 16.61	55.75 units on a scale (0-100) Standard Deviation 17.14

Adverse Events

PCIT-ED

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait List

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joan Luby

Early Emotional Development Program at Washington University School of Medicine

Phone: 3142862730

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place