21 and older, any sex, with Modified DECIDE Intervention or Treatment as Usual Care Group. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Parent Needs & Resources Domain of CANS - Provider Arm OnlyPrimary· baseline and immediately post intervention (T2), up to 4 weeks
Change in Parent Needs \& Resources Domain of CANS is measured using three items from the Parent Needs \& Resources Domain of the Child and Adolescent Needs and Strengths (CANS), Involvement with Care, Knowledge, and Organization. Each item is scored 0, 1, 2, or 3. A domain score is created by calculating the sum of the items. The domain score ranges from 0 to 9 with higher scores meaning more need/less strength and is calculated at baseline and immediately post-intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from
Group
Value
95% CI
Modified DECIDE-Provider Arm
0
-2 – 0
Change in Parent Activation Measure Mental Health (P-PAM-MH) - Parent Arm OnlyPrimary· baseline and immediately post intervention (T2), up to 4 weeks
Change in Parent Activation Measure Mental Health is measured using a 13-item scale. Items are scored using a 4-point Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw item scores are summed and scaled from 0-100. Higher scores indicate greater activation and is calculated at baseline and immediately post-intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -100 to 100 with positive values indicating an increase in activation.
Group
Value
95% CI
Modified DECIDE-Parent Arm
15.7
4.9 – 25.5
Change in Parent Participation Engagement Measure (PPEM) - Provider and Parent Arm OnlySecondary· baseline and immediately post intervention (T2), up to 4 weeks
Change in Parent Participation Engagement Measure is measured using a 5-item scale that measures the frequency with which the parent engaged during clinical encounter or parent-provider interaction. Behaviors assessed include asking questions, making suggestions or sharing one's opinion or point of view, and participating in therapeutic activities. Response options are on a 5-point scale ranging from 1 = "not at all" to 5 = "very much". A mean score is calculated using all 5 items and has a range of 1 to 5. Higher scores indicate greater frequency of parent engagement and is calculated at base
Group
Value
95% CI
Modified DECIDE-Provider Arm
0.4
± 0.9
Modified DECIDE-Parent Arm
0.5
± 0.8
Change in Familiarity With Perspective Taking - Provider Arm and Provider Subgroup Arm OnlySecondary· baseline and immediately post intervention (T2), up to 4 weeks
Change in familiarity with perspective taking is measured using a single item that measures familiarity with concept of perspective taking. The response options are 0=Not at all, 1=A little bit, and 2=A lot. A higher score means more familiarity with the concept of perspective taking and is calculated at baseline and post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -2 to 2 with positive values indicating an increase in familiarity with the concept of perspective taking.
Group
Value
95% CI
Modified DECIDE-Provider Arm
0
0 – 1
Provider Subgroup Study
1
0 – 1
Change in Familiarity With Attribution Errors - Provider Arm and Provider Subgroup Arm OnlySecondary· baseline and immediately post intervention (T2), up to 4 weeks
Change in familiarity with attribution errors is measured using a single item that measures familiarity with concept of attribution errors. The response options are 1=Not at all, 2=A little bit, and 3=A lot. A higher score means more familiarity with the concept of attribution errors and is calculated at baseline and post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -2 to 2 with positive values indicating an increase in familiarity with the concept of attribution errors.
Group
Value
95% CI
Modified DECIDE-Provider Arm
1
0 – 1
Provider Subgroup Study
1
1 – 1
Change in Familiarity With Receptivity - Provider Arm and Provider Subgroup Arm OnlySecondary· baseline and immediately post intervention (T2), up to 4 weeks
Change in familiarity with receptivity is measured using a single item that measures familiarity with concept of receptivity. The response options are 1=Not at all, 2=A little bit, and 3=A lot. A higher score means more familiarity with the concept of receptivity and is calculated at baseline and post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -2 to 2 with positive values indicating an increase in familiarity with the concept of receptivity.
Group
Value
95% CI
Modified DECIDE-Provider Arm
0
0 – 1
Provider Subgroup Study
0
0 – 1
Change in Communication Scale of the Kim Alliance Scale Refined (KAS-R): Post-intervention - Parent Arm OnlySecondary· baseline and immediately post intervention (T2), up to 4 weeks
Change in the Communication scale of the Kim Alliance Scale Refined is measured using a 4-item scale that measures perception of parent-provider communication. Response categories include 1 = never to 4 = always. Items are summed with higher scores indicating higher quality of communication and is calculated at baseline and post intervention (range 4 to 16). Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -12 to 12 with positive values indicating an increase in quality of communication.
Group
Value
95% CI
Modified DECIDE-Parent Arm
0
0 – 1
Change in Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form: Post-intervention - Parent Arm OnlySecondary· baseline and immediately post intervention (T2), up to 4 weeks
Change in Perceived Efficacy in Parent-Physician Interactions is measured using a 10-item scale that measures patient's confidence in ability to elicit and understand information from and communicate information to providers. Response categories are 1 = low to 10 = high. A total score is obtained by summing all individual scores with higher scores indicating greater perceived confidence in ability to elicit and understand information from and communicate information to providers (range = 10 to 100). Change from baseline equals the score immediately post-intervention minus the score at baseline
Group
Value
95% CI
Modified DECIDE-Parent Arm
14
8 – 15
Change in Perception of Care Quality Survey: Post-intervention - Parent OnlySecondary· baseline and immediately post intervention (T2), up to 4 weeks
Change in Perception of Care Quality is measured using a single item that measures overall rating of parent's perception of care quality. Reponses are 1 to 10 where 1=Worst possible care to 10=Best possible care. Higher scores indicate perceptions of higher quality of care. Item was collected at baseline and immediately post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -9 to 9 with positive values indicating an increase in rating of perception of higher quality of care.
Group
Value
95% CI
Modified DECIDE-Parent Arm
0
0 – 3
Sponsor's own description
The DECIDE Parent-Provider Intervention is designed to support parents caring for adolescents who are receiving treatment for Disruptive, Impulse-Control, and Conduct disorders. Participating in DECIDE study may help you effectively ask questions and participate in decisions about your adolescent's care. There were three active study arms, each arm had a pre-post design of the DECIDE modified intervention.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 28 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04445155.